Seeking talent near: Princeton, NJ

Position Summary

The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s growing portfolio of drug candidates at all stages of development, and will provide technical oversight, expertise and guidance of externalized drug product development related activities. The scope includes development of formulations, package, and process for all modes of administration including oral solid, liquid, and injectable dosage forms for candidates ranging from clinical development to process validation and life cycle management. The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution. The role will be critical in ensuring that we optimize development, reduce risk and accelerate the development of new assets for commercialization.

Primary Responsibilities

• Designs and develops pharmaceutical formulations and manufacturing processes to support clinical trials, registration and product launch.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, scale up, and commercialization of the new drug candidates in the Acadia pipeline.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development, scale-up to manufacturing of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• Review the clinical supply requirements with the clinical supply managers and plan requisite manufacturing schedule with the CSPs to ensure uninterrupted supply of clinical trial materials.
• Perform risk assessments of manufacturing process and product at key development milestones and address the findings with the relevant CSPs.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with analytical, manufacturing, quality assurance and regulatory counterparts to develop plans and protocols for drug product development and for life cycle management of the established products.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections.
• Other responsibilities as assigned.

Education and Experience

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.
• A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.
• Demonstrated success in the field of formulations and dosage form development.  
• Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the dosage form formulation and package development, manufacturing process development, scale-up, optimization and validation processes.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

#LI-HYBRID #NC1

Director, Formulation Sales – West Coast

Location: San Diego, CA (Debut’s Headquarters)

Reports To: Chief Commercial Officer

Type: Full-Time

Salary Range: USD $140,000–$175,000 per annum (base) + performance-based incentives, commensurate with experience

MAKE YOUR DEBUT

About Debut

Debut is a vertically integrated biotechnology company pioneering the next generation of high-performance cosmetic active ingredients. We combine AI-driven discovery with proprietary bioprocessing to develop the highest performing and clinically proven active ingredients that outperform conventionally sourced alternatives. From molecule to market, Debut controls the full value chain: ingredient discovery, formulation science, clinical validation, and scaled manufacturing delivering novel active ingredients to the global beauty industry faster and with better efficacy data than traditional suppliers.

Summary

Debut is seeking a commercially driven, highly connected Director of Formulation Sales to own and grow our West Coast formulation business. This is a hunter and closer role focused exclusively on selling custom-developed finished formulations to beauty brands, not an ingredient sales role. The right candidate has spent their career inside the beauty contract manufacturing ecosystem, knows how prestige and emerging brands buy, and understands how to move a formulation brief from first conversation to signed commercial agreement. The ideal candidate is deeply embedded in the West Coast beauty community, with active relationships across the LA, San Francisco, and Pacific Northwest markets. They will carry an established book of brand relationships, arrive ready to engage immediately, and be comfortable presenting to a VP of Product Development. Reporting directly to the Chief Commercial Officer, this person will serve as Debut’s primary commercial driver for West Coast formulation revenue.

Essential Functions

• Own and drive Debut’s West Coast formulation sales strategy, with full accountability for revenue achievement and expansion of the active customer base across prestige, masstige, and indie beauty segments in the West Coast market.
• Leverage an existing, active network of decision-maker relationships at major beauty brands with a concentration in West Coast-headquartered prestige, masstige and indie brands including VP-level and above contacts in product development, R&D, and procurement, to open doors, secure formulation briefs, and accelerate commercial cycles. Proactively identify, prioritize, and pursue new brand partnerships across skincare and color cosmetics to continuously expand Debut’s West Coast brand portfolio.
• Lead the full formulation sales cycle from initial brand engagement through briefing, proposal, sampling, pricing, and first production purchase order, coordinating closely with Debut’s R&D, Operations and formulation teams throughout. Awarded formulations are manufactured and filled by Debut’s CM partners, and this role is responsible for managing a smooth commercial handoff to ensure seamless execution.
• Develop deep understanding of each brand customer’s NPD roadmap, franchise architecture, launch/portfolio priorities and translate that intelligence into tailored product/formulation proposals that integrate Debut’s active ingredient platform.
• Represent Debut at US and international industry trade shows, brand summits, and brand innovation strategy sessions. Plan and execute brand-facing activations in coordination with the marketing and R&D teams ensuring Debut’s custom formulation capabilities are compellingly presented.
• Build and maintain a rigorous, accurate sales pipeline detailed in Debut’s CRM, providing the CCO with clear visibility into project status, revenue forecasts, and market intelligence on a regular cadence.
• Serve as a trusted commercial partner to brand customers throughout the product development lifecycle, managing the relationship from initial briefing through launch and beyond with the goal of securing repeat ongoing business. Translate market feedback including brand needs, competitive dynamics, and formulation trends into actionable insights that inform Debut’s formulation roadmap, and collaborate cross-functionally with R&D, operations, and the broader commercial team to ensure brand commitments are met.
• Operate with a high degree of autonomy and entrepreneurial urgency in a fast-moving, early-stage commercial environment, building a strong project pipeline while simultaneously closing business.

Education and Experience

The successful candidate will have a genuine passion for beauty and deep roots in the Prestige, Masstige and Indie beauty world. They are a product user, a relationship builder, and a closer.  Someone who understands how brands think and can credibly represent Debut’s formulation capabilities at every stage of the NPD process. They are organized, resilient, and motivated by winning. A bachelor’s degree is required; a background in cosmetic science, chemistry, or product development is a strong plus.

• 8+ years of experience in sales or in beauty product development within the contract manufacturing field or ingredient sales, with a meaningful portion of that time spent selling formulation or custom development services directly to beauty brands.
• Established, active network of decision-maker relationships at major beauty brands, with meaningful concentration in West Coast-headquartered companies across skincare and/or color cosmetics. Candidates must be able to demonstrate existing, active brand relationships, not historical contacts in their application materials.
• Customer-centric mindset with the ability to act as a true extension of a brand’s product development team. Strong interpersonal skills and a natural ability to build trust at every level of an organization.
• Demonstrated track record of meeting and exceeding revenue targets in a B2B formulation or contract manufacturing sales role, with experience managing complex sales cycles from prospecting through to contract execution.
• Strong technical fluency sufficient to engage credibly with brand R&D and product development teams on formulation performance, ingredient claims, and product development timelines without needing to be a chemist.
• Exceptional communication, presentation, and negotiation skills, with the ability to craft and deliver compelling product narratives tailored to brand-specific business priorities. Assertive and confident in closing.
• Willingness and ability to travel domestically and internationally as business needs require, including attendance at Debut’s innovation shows or key industry trade shows.
• Proficiency with CRM platforms (Monday, Salesforce or equivalent) and demonstrated discipline in pipeline management and forecasting. Accountable, KPI-focused, and goal-oriented.
• Experience working in or alongside an early-stage, high-growth company is a plus. Comfort operating in an environment where structure is still being built is essential. Self-motivated, proactive, and able to manage multiple priorities against tight timelines.

Essential Physical Characteristics

The physical characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

• Frequent sitting, standing, and walking during customer meetings, trade shows, and extended travel.
• Repetitive use of hands to operate computers, mobile devices, and presentation equipment.
• Ability to carry and transport sales materials and samples weighing up to 30 pounds.
• Frequent domestic and international air travel.
• Ability to navigate diverse physical environments including manufacturing facilities, trade show floors, and customer offices.

Condition of Employment

As part of Debut’s pre-employment process, prospective candidates will undergo a background check prior to beginning employment. Additional types of background investigations may be conducted based on the job-related activities of the position.

Debut is an equal opportunity employer. All applicants will be considered for employment without attention to age, nationality, sex, marital status, pregnancy status, caregiving responsibilities, race, religion, language, disability, or mental health conditions. Employment decisions at Debut are based on merit, qualifications, and business needs.

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director in the Early Stage Drug Product Development organization at Acadia is responsible for the development of pharmaceutical formulations primarily intended for early-stage clinical trials and preclinical animal studies. This role also supports drug discovery teams by assisting in the selection of optimal drug candidates through detailed physicochemical characterization and assessment of compound properties. The incumbent will focus on formulation strategies tailored to early development phases, ensuring that candidates are suitably prepared for initial safety and efficacy evaluations. Additionally, collaboration with research scientists and external partners is essential to address technical challenges and advance promising compounds toward clinical readiness.

The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues The role will be critical in ensuring that we select developable drug candidates, reduce risk and accelerate the introduction of new chemical entities into the Acadia pipeline.

Primary Responsibilities
 

• Designs and develops pharmaceutical formulations to support early stage clinical trials, providing acceleration options such as on-site compounding and impromptu type of drug products.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, oversee operations at existing suppliers.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• With Translational Sciences teams, plans conduct of preclinical and toxicological studies and develops requisite formulations for the same considering developability of the new drug candidates.
• Develops phase appropriate formulations for new drug candidates in FIH, Phase 1 and POC studies employing resource sparing approaches such as compounded formulations and/or on-site preparations.
• Conduct physicochemical characterizations of the new drug candidates to support developability assessments.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with the CMC team, late-stage formulation team, and formulation development management to establish the development strategy for formulation of the new drug candidates.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Collaborates with regulatory teams in preparation of the health authority submissions for the early clinical trial applications (e.g. IND, CTA, IMPD)
• Other responsibilities as assigned.

Education/Experience/Skills

Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.  A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.  Demonstrated success in the field of formulations and dosage form development.   Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the physicochemical characterization of new drug candidates to assess developability, formulations for early stage clinical studies, and dosage form formulation and package development.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel to domestic and international locations is required.

#LI-HYBRID #NC1 

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

We are actively seeking qualified candidates to join our talent pipeline for future client engagements.  

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

About Tr1X

Tr1X is a private, clinical-stage biotechnology company focused on developing a novel class of regulatory T cell-based products to cure autoimmune and inflammatory diseases. Founded by industry experts, including the scientists who discovered Type 1 regulatory T (Tr1) cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies for autoimmune diseases with high unmet medical need. Our TRX cells are designed to mimic the function of naturally occurring Tr1 cells, which work to restore immune tolerance, stopping severe autoimmune and inflammatory disease in its tracks. Tr1X is the first company ever to use an allogeneic engineered Tr1 cell therapy in clinical trials. Tr1X is headquartered in San Diego, CA. For more information, please visit www.tr1x.bio.

Position Summary

The Senior Scientist, LNP Platform & Process Development (Scientist) is an experienced hands-on, lab-based, individual contributor that leads the design, development, and optimization of lipid nanoparticle (LNP) formulation and process development efforts supporting the Tr1X in vivo CAR-Treg platform. This individual plays a central role in developing and advancing the targeted lipid nanoparticle (tLNP) delivery systems from early research optimization through scalable, IND-enabling development.

This is a high-impact, foundational role within the company. The Scientist helps design and implement the LNP backbone of the platform and influence both short-term program execution and long-term manufacturability strategy. The Scientist brings deep hands-on expertise in LNP formulation and process development, strong analytical rigor, and the ability to thrive in a fast-paced startup environment.

Key Responsibilities

• Contribute to the design, development, and optimization of LNP formulations for mRNA delivery, including targeted LNP systems incorporating conjugated or functionalized lipids.
• Evaluate lipid composition, formulation parameters, and mixing conditions to optimize particle size, polydispersity, encapsulation efficiency, stability, release characteristics, and biological performance.
• Develop scalable, GMP-compatible manufacturing processes to support program advancement.
• Apply Quality by Design (QbD) principles and Design of Experiment (DoE) studies to study design and execution.
• Lead the development and optimization of analytical characterization methods (both in-house and at the external CDMO), including but not limited to DLS, fluorescence-based assays such as Ribogreen, HPLC/UPLC methods (CAD, UV, IP-RP, SEC, IEX), LC-MS, and endotoxin testing.
• Interpret analytical and stability data to establish meaningful correlations between physicochemical properties and biological function.
• Collaborate closely with platform biology teams to support in vitro and in vivo studies, prepare development reports and technical documentation, and contribute to technology transfer activities with external CDMO partners.
• Spearhead IND-enabling documentation and contribute to defining the long-term strategy for scalable LNP platform development.
• Perform other responsibilities as required based on business needs.

Required Qualifications & Experience

• Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, or a related field with a minimum 4 years of relevant industry experience; or M.S. with 8+ years; or B.S. with 10+ years.
• Demonstrated in-depth expertise in LNP formulation and process development, including hands-on experience with microfluidic or scalable mixing technologies and downstream purification strategies such as TFF.
• Strong experience with analytical characterization of LNP systems and application of statistical design tools for process optimization.
• Highly organized, scientifically rigorous, and capable of independently driving projects while collaborating effectively in a multidisciplinary startup environment.
• Experience with mRNA therapeutics or nucleic acid delivery systems.
• Prior exposure to immunotherapy or cell therapy platforms preferred.
• Familiarity with regulatory expectations for CMC development and experience supporting technology transfer to external manufacturing partners preferred.
• Experience correlating formulation attributes with in vivo performance highly desirable.
  Ability to actively serve, collaborate, and develop relationships inside and outside the organization.
• Excellent written and oral communication skills.
• Strong analytical and problem-solving skills; great attention to detail and the ability to drive timely and fact-based decision making.
• Ability to function in a rapidly changing environment and handle multiple priorities.
• Demonstrated ability to partner, build trust, and cultivate positive working relationships with CDMOs.
• Experience with mRNA production and analytical quality control preferred.
• Effectively communicate changes and resolve issues with CDMOs.
• Lead and/or participate in cross functional development and manufacturing projects to ensure company objectives are met and exceeded.
• Ability to don and wear appropriate clean room attire and wear all required Personal Protective Equipment.

Other Requirements

• Legally authorized to work for any employer in the U.S.
• Position is on site in San Diego
• Travel may be required up to 10% of the time

The job responsibilities and requirements provided above are intended to describe the general nature of the work performed by individuals assigned to this job classification. It is not intended to be an exhaustive list of all duties and requirements. Tr1X retains the right to add, change, or delete duties, education, experience or any other requirements of the position at any time.

Working at Tr1X

At Tr1X, our team is united by a singular shared mission: to transform patients’ lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured.

Base Pay Range Anticipated: $145,000 - $160,000

Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position.

Compensation and Benefits

Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays.

Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at careers@tr1x.bio.

Notice to Employment Agencies

The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.

Account Manager  

Summary  

The primary focus for this position will be working with external brand partners, contract manufacturers of personal care products, and supporting sales and operations. Regarding external brand partnerships and sales, activities will be devoted to customer contacts, proactive problem diffusion, and management of all new projects and open orders. For operations, you will be working closely and communicating with the managers of each existing department to develop cohesive strategies and corresponding timelines for each new project.  Effective and efficient management of product briefs with the focus on developing high quality products that drive to repeat customer PO's. Support business development strategy and execution. Execute regular order process.  

Essential Functions 

• Support brand partners with timely and accurate cost estimates / quotes, timelines and other information 

• Receive and process all incoming product briefs and redirects 

• Liaison between contract manufacturer, external brands and internal stakeholders to clearly and effectively execute projects 

• Have working knowledge of the contract manufacturing process, specifically related to skincare, and preferably broader within personal care, color cosmetic products is a plus 

• Where possible, adjust project management approach and coordinate with the Debut team to fit the unique needs of each customer while respecting Debut processes  

• Utilize project management tools to track project progress, manage deadlines, and communicate status updates effectively to all stakeholders 

• Develop and maintain project schedules, ensuring that milestones are met, and any potential delays are promptly addressed 

• Be the main point of contact to the customer 

• Ensure R&D and costing paperwork is complete and accurate before sending to the customer 

• Actively manage the scale-up process for any customer products starting the first production run including carefully managing customer expectations  

• Think strategically about each customer's New Product Development (NPD) projects to drive customers to the best decision as efficiently as possible 

• Proactively raise risks, deadlines, and concerns to meet launch timeline objectives 

• Support business development initiatives as needed via sample and presentation coordination 

• Actively participate in market research on behalf of Debut 

• Participate in customer vetting as needed 

• Visit customers and contract manufacturers as needed 

• Clear and effective communication with brand partners and to Debut including executing the weekly order process and identify exceptions 

• Support the long-term scheduling process as well as daily / weekly scheduling processes 

• Support quality in the management of any quality issues that arise as it relates to resolution and communication to the customer  

• Investigate and resolve inventory questions and discrepancies 

• Forecasting future orders  

Education and Experience 

• BA or BS in chemistry, chemical engineering, biochemistry, or related field preferred 

• Minimum 3+ years of account management experience required, including brand-facing client engagement with strong ownership and accountability. Prior experience in skincare formulation account management is required 

• Experience working at or closely with a Contract Manufacturer of personal care products preferred 

• Knowledge of color cosmetics and ability to color match is a plus 

• Experience with technology transfer from bench scale to full production  

• Understanding of testing requirements necessary for product launch 

• Experience in Personal Care & Cosmetic Products required 

• Excellent Customer Service skills, ability to communicate clearly to both external and internal customers  

• Ability to work successfully with customers in difficult situations and communicate clearly either verbally or in writing 

• Preferable to have direct experience in the personal care, cosmetic or fragrance industry 

• Ability to adapt quickly to changing priorities in a fast-paced environment 

• Perform essential duties and responsibilities efficiently, accurately, and safely 

Essential Physical Characteristics 

The physical characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.  

• Continuous upward and downward flexion of the neck 

• Frequent: sitting, repetitive use of hands to operate computers, printers and copiers 

• Frequently uses hands to feel objects or control tools (e.g. pipetting).  Laboratory operations require dexterity and care to perform studies as required 

• Occasional: walking, standing, climbing stairs, bending and twisting of neck, bending and twisting of waist, squatting, simple grasping, reaching above and below shoulder level, and occasional lifting and carrying of files or material weighing up to 50 pounds 

• Must be willing to work with biohazardous agents (up to BSL2) 

• The R&D laboratory will result in exposure to hot and cold temperatures, noise, fumes, limited dust, and oily coolants 

• The performance of this position will present exposure to an industrial environment and requires support and compliance with the published Company PPE policy including but not limited to the use of personal protective equipment such as safety glasses with side shields, appropriate attire, safety shoes, hard hat, hearing protection, etc.  

Condition of Employment 

As part of Debut’s pre-employment process, prospective candidates will undergo a background check prior to beginning employment. Additional types of background investigations may be conducted based on the job-related activities of the position. 

Debut is an equal opportunity for employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. 

Salary: $80,000 - $110,000