Job Title: Associate Director, CMC Lead, Late-Stage Biologics      

Location: Remote OR Hybrid 3 days/week in office if located near Waltham, MA will be required.         

Role Overview: The Associate Director of CMC Leadership will provide technical and strategic leadership for late-stage CMC activities supporting the development, characterization, validation, licensure application, commercial readiness, and lifecycle management of biologics manufacturing process, with a focus on monoclonal antibodies. This role is a critical addition to our growing organization and is highly visible within the CMC team and across other functions. Serving as a matrix leader, this role will work closely with the CMC function leads in drug substance, drug product, analytical, and clinical supply chain. This role will also partner closely with Program Management, Quality, Regulatory Affairs, CDMOs, and consultants.

The ideal candidate is an established technical and matrix leader with hands-on technical experience in biologics process development and manufacturing support, and proven track record in leading cross-functional teams to achieve complex technical and regulatory milestones and bring late-stage biologics therapeutics to commercialization.

Key Responsibilities: 

• Oversee technical operations and lead strategy discussions for late-stage CMC activities including process characterization, PPQ, licensure application, regulatory inspection, and lifecycle management of monoclonal antibody therapeutics.
• Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports, in-process-control documents, process validation master plan, and BLA Module 3 sections.
• Lead CMC meetings and ensure drug substance, drug product, analytical, clinical supply chain, quality, program management, and regulatory affairs teams are aligned with overall CMC and program strategy.
• Maintain an effective action tracker for internal and external CMC deliverables. Adapt to changing priorities to ensure corporate CMC objectives are at the forefront.
• Facilitate problem solving, action planning, and decision making within the CMC team while keeping program level stakeholders informed at regular intervals.
• Foster a strong relationship with CDMOs and consultants. Ensure the external partners are fully aligned on Oruka strategy and goals.
• Liaise with internal and external stakeholders to support timely completion of technical. documents, batch records, campaign readiness, lot release, campaign reports, change controls, deviation investigations, and CAPAs.
• Partner with CDMO counterparts to oversee all CMC service, ensuring high quality work, timely delivery, and efficient meetings.
• Collaborate with manufacturing and clinical supply chain stakeholders to ensure robust clinical supply and distribution plans.
• Drive preparation and presentation of CMC content for internal and external meetings, facilitate cross-functional offsite workshops, and help organize business review meetings with CDMOs
• Support the diligence process and contract negotiation with new CDMOs and consultants.
• Work with program managers and Finance to track budgets, contracts, and change orders.
• 20-25% travel in support of diligence process, strategy discussion meetings, and activity supervision at CDMOs.

Qualifications:

• Master’s or PhD in relevant disciplines with 10+ (MS) or 7+ (PhD) years of experience in biologics CMC functions including upstream, downstream, analytical, and drug product.
• Must have experience leading late- and commercial-stage CMC activities including process characterization, PPQ, BLA, regulatory inspections, life cycle management, and post approval submissions.
• Prior matrix leadership experience is highly preferrable. Have led cross-functional CMC teams to drive strategy alignment on risk mitigation, resource planning, process validation, regulatory filing, and post approval changes.
• Experience with pre-filled syringe and/or auto-injector is a plus.
• Strong program management skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets.
• In-depth knowledge of CMC quality and regulatory requirements in support of global regulatory filings
• Experience with managing CDMOs. Demonstrated track record of successful tech transfers to commercial CDMOs
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
• Strong sense of urgency and ability to direct the CMC team towards their deliverables in a highly fast paced environment

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA -OR-remotely, is $182,000 to $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Job Title: Scientist/Senior Scientist, Upstream, Process Development & Manufacturing (Biologics)  

Location: Hybrid – Waltham, MA required to be in-office 3 days/week -OR- Remote

Position Overview: 

We are seeking an experienced and motivated Scientist/Senior Scientist to support upstream manufacturing activities. This role will be instrumental in contributing to process development and delivery of clinical trial material at CDMOs. The ideal candidate will collaborate cross-functionally within the CMC team including downstream, analytical, and drug product and other stakeholders such as QA, regulatory, and program management.  The successful candidate will help support CMC strategy in a fast-paced, innovative environment. You will be an integral part of a growing team with an opportunity to contribute towards developing best-in-class biotherapeutics.

Key Responsibilities

• Support cell culture process development and manufacturing activities at external CDMOs.
• Execute and support upstream process development, scale-up, and tech transfer to enable drug substance supply.
• Partner closely with CDMOs to execute fit‑for‑purpose upstream processes aligned with development timelines.
• Support planning and execution of drug substance manufacturing campaigns, including batch record review, sampling plans, deviations, investigations, and change management.
• Serve as person‑in‑plant (PIP) during key manufacturing campaigns to support real‑time issue resolution.
• Identify and mitigate technical and development risks using phase‑appropriate strategies.
• Manage upstream timelines and deliverables to ensure on‑time material delivery and effective cross‑functional handoffs.
• Apply phase‑appropriate QbD principles and analyze process data to support development decisions.
• Contribute to upstream sections of regulatory submissions (INDs, IMPDs).
• Travel up to 20–25% to support CDMO activities.

Qualifications

• PhD or Master’s degree in Engineering or Biological Sciences with ~3-5 years of experience in upstream process development and/or manufacturing of biologics.
• Strong hands‑on expertise in CHO cell culture process development, scale‑up, media optimization, and bioreactor operations; mAb experience preferred.
• Solid understanding of upstream process parameters, product quality attributes, and troubleshooting in clinical manufacturing.
• Experience supporting or leading upstream tech transfer to CDMOs.
• Familiarity with phase‑appropriate cGMP and development regulatory expectations.
• Demonstrated ability to analyze and interpret process and manufacturing data.
• Exposure to upstream process characterization (PC) and process performance qualification (PPQ) is a plus
• Strong written and verbal communication skills and ability to work effectively with cross‑functional and external partners.
• Self‑motivated, execution‑focused, and comfortable operating in a fast‑paced, early‑stage biotech environment.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $130,000 to $208,000, who will work in Waltham, MA or remote if not living within commutable distance to Waltham. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Job Title: Senior Manager, Clinical Supply Chain (Biologics)         

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.          

Role Overview: We are seeking an experienced and motivated candidate to execute clinical supply chain activities in support of early-to-late-stage clinical trials. In this role, you will be responsible for overseeing labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies. You are an ideal candidate for this role if you enjoy working in a fast-paced, high-touch environment establishing strong relationships across CMC, Clinical, Program Management, Regulatory and Quality. You will be reporting to and working alongside the head of Clinical Supply Chain to help establish Clinical Supplies processes and best practices, while supporting multiple clinical trials across US, Canada and EU. You are highly communicative and motivated to produce results effectively, efficiently and early to support global clinical supply chain activities in support of vials and pre-filled syringes.

Key Responsibilities: 

• Execute clinical supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies
• Author, review and/or approve clinical labels, packaging batch records, shipping documents, stability, clinical study, and pharmacy protocols
• Serve as subject matter expert to generate label texts, distribution lanes, randomization codes, packaging specifications, and designs in compliance with regulations and GMPs
• Support site initiation visits (SIV), trials and OLEs by providing timely delivery of supplies, CoAs, stability, expiration, handling and destruction information
• Plan and adapt to changes against clinical demands, trial and protocol changes, expiration, and inventory management
• Support clinical supply and logistics planning in support of global regulatory filings
• Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot releases, change controls, deviations, and CAPAs
• Support clinical distribution across US, Canada and EU through both IRT and manual driven site shipments and depot transfers
• Verify with Quality the accuracy within blinded studies’ drug release, shipments & IRT setup
• Identify and execute process improvements through report development and SOPs
• Build strong relationships and partners with other leaders across CMC, quality, clinical operations, regulatory, and external CDMO/CPOs
• Serve as person-in-plant (PIP) during label and packaging campaigns
• 20-25% travel in support of diligence and campaign execution at the CPOs

Qualifications:

• Bachelor’s or Master’s in a scientific discipline with 6+ years of relevant experience in clinical supply chain and logistics
• Must have hands-on experience managing supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies
• Experience with clinical supply chain involving cold chain products is a plus
• Exposure to support clinical supply activities involving vials or pre-filled syringes is a plus
• Demonstrated experience managing import/export for clinical studies in US, Canada and EU
• Strong clinical supply skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets
• In-depth knowledge of quality and regulatory aspects of clinical supply chain in support of simple to complicated multi country clinical studies
• Demonstrated track record of successful tech transfers to commercial CPOs with an eye towards late stage and commercial launch
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
• Must have a creative, organized and strategic attitude with the ability to work in a fast-paced environment

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA, is $161,0000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Job Title: Associate Director/Director, Analytical Development and Validation, Tech Ops (Biologics)         

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Remote may be considered.        

Role Overview:

The Associate Director/Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities supporting the development, validation, and lifecycle management of biologic drug products, with a focus on monoclonal antibodies. This role will lead method validation and comparability efforts in support of BLA/MAA submissions, process changes, and commercial readiness, while partnering closely with CMC, Quality, Regulatory Affairs, and external partners.

The ideal candidate is a hands-on leader with deep expertise in analytical method validation, device functional testing, regulatory expectations for late-stage biologics, and the ability to guide teams through complex technical and compliance-driven milestones. This role is highly visible within the CMC team and a pivotal addition to our growing organization where you will play an integral role in supporting multiple programs’ analytical activities in support of releasing supplies for clinical trials and preparing for commercialization across US, Canada and EU.

Key Responsibilities: 

• Lead late-stage analytical development activities for biologics, including method validation, method qualification, and method transfer for release, stability, characterization and device functional testing assays.
• Provide subject matter expertise for ICH Q2/Q14, USP/EP/JP, and global regulatory expectations related to analytical methods.
• Oversee validation of assays including potency/bioassays, purity and impurities (SEC, CE-SDS, icIEF, HPLC), identity, characterization, residuals and device functional testing.
• Experience with PFS and Autoinjector functional testing is required, including validation per ISO guidance(s).
• Drive analytical strategies to support BLA/MAA submissions, post-approval changes, and comparability studies.
• Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness.
• Support analytical risk assessments, control strategy development, and lifecycle management
• Serve as analytical lead for regulatory interactions, including agency questions and inspections.
• Build, mentor, and lead a high-performing analytical development team (internal and/or external)
• Set technical direction, priorities, and timelines for late-stage analytical
• Manage and provide technical oversight to CDMOs and contract
• Review and approve protocols, validation reports, development reports, and regulatory
• 20-25% travel is required for this role.

Qualifications: 

• Experience with monoclonal antibodies and PFS/Auto Injectors is a
• Associate Director: Master’s (7+ years) or PhD (5+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
• Director: Master’s (10+ years) or PhD (7+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
• Relevant industry experience in method development, qualification, validation and method transfer in support of ongoing development and/or commercialization of biologics.
• Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based), device functional testing per ISO
• Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada and EU.
• Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.
• Experience with late-phase comparability studies, especially geared toward
• Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies
• Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Must have a creative and strategic attitude with the ability to work in a fast-paced

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA is $182,000-208,000 for Associate Director and $213,000-240,000 for Director. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Job Title: Associate Director / Director, Device Development (Prefilled Syringes & Auto-Injectors)

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Remote may be considered. 

Position Summary

We are seeking an experienced and driven Associate Director or Director of Device Development to lead the end-to-end development of drug delivery systems, with a focus on prefilled syringes and auto-injectors for late-stage programs and commercialization.

This role will be responsible for integrating medical device engineering, human-centered design, and human factors engineering into combination product development, ensuring safe, effective, and patient-friendly delivery solutions. The ideal candidate brings deep expertise in biomedical engineering, device development, and regulatory requirements for combination products, along with a track record of advancing programs from clinical stages through commercial launch.

Key Responsibilities

Device & Combination Product Development

• Lead development of prefilled syringes, auto-injectors, and related delivery systems from late-stage clinical development through commercialization
• Define and execute device development strategies, including design, verification, validation, and lifecycle management
• Oversee combination product integration, ensuring alignment with CMC, clinical, and regulatory strategies

Human-Centered Design & Human Factors Engineering

• Drive human-centered product development, incorporating patient, caregiver, and healthcare provider needs
• Lead human factors engineering (HFE) activities, including use-related risk analysis, formative and summative (validation) studies
• Ensure compliance with FDA, EMA, and global HFE/usability requirements

Technical Leadership

• Provide subject matter expertise in biomedical engineering and device technologies
• Lead cross-functional teams across development, clinical, regulatory, quality, and manufacturing
• Independently manage external partners, including device manufacturers, design firms, and testing laboratories

MSAT & Manufacturing Support

• Provide MSAT leadership for device and combination product manufacturing across clinical and commercial stages
• Serve as Person-in-Plant (PIP) during manufacturing campaigns, ensuring on-site technical oversight and rapid issue resolution
• Lead and support manufacturing campaigns, including engineering runs, clinical, PPQ, and commercial production
• Partner with CMOs and internal teams to ensure robust manufacturing processes, tech transfer, and scale-up
• Drive investigations, deviations, CAPAs, and continuous process improvements related to device and combination product manufacturing

Regulatory & Quality

• Support regulatory submissions (e.g., IND, BLA) with device-related content
• Ensure compliance with combination product regulations (21 CFR Part 4, ISO 13485, IEC 62366, ISO 14971)
• Partner with Quality to ensure design controls and risk management processes are implemented effectively

Qualifications

Education

• PhD, or MS in Biomedical Engineering, Mechanical Engineering, or related field

Experience

• Associate Director: 8+ years of relevant experience
• Director: 12+ years of relevant experience
• Significant experience in combination products and drug delivery devices, particularly prefilled syringes and/or auto-injectors
• Proven track record supporting late-stage development and commercialization

Technical Expertise

• Strong knowledge of:
• Medical device design and development processes
• Human factors engineering / usability engineering
• Risk management
• Design controls and validation requirements
• MSAT and manufacturing support for combination products
• Experience with biologics delivery systems preferred

Leadership & Collaboration

• Demonstrated ability to lead cross-functional, matrixed teams
• Strong communication skills with experience influencing senior leadership and external partners
• Strategic mindset with the ability to balance technical depth and business objectives

Preferred Qualifications

• Experience with regulatory interactions (FDA, EMA) for combination products
• Background in patient-centric design
• Experience with commercial device manufacturing and supply chain management

Additional Requirements

• Ability to travel up to 20%, including visits to manufacturing sites, external partners, and testing facilities

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA is $182,000-208,000 for Associate Director and $213,000-240,000 for Director. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Job Title: Director / Senior Director, Regulatory CMC (Biologics)       

Location: Hybrid – Waltham, MA Candidates will be required to be in-office 3 days/week.          

Role Overview:

We are seeking an experienced and motivated regulatory CMC leader to shape strategy and execution across early-to-late-stage biologics programs. In this role, you will own the development of high-quality regulatory CMC submissions and guide cross-functional teams on phase-appropriate global regulatory expectations. You are an ideal candidate if you bring deep expertise in biologics development and manufacturing, including strong experience with drug substance and drug product CMC submissions. You will have the opportunity to influence program strategy, foster collaboration across CMC, QA, RA, Supply Chain, and external partners, and drive key decisions that support multiple programs in our rapidly growing biologics pipeline. This is a highly visible role where you will be responsible for submissions that are aligned with FDA, EMA, ICH, and WHO guidelines while supporting corporate and program level objectives.

Key Responsibilities: 

• Own and drive global regulatory CMC strategy for drug substance and drug product across all stages (IND through BLA)
• Lead development of high-quality CMC dossiers, timelines, and submission strategies for global filings
• Serve as the CMC regulatory SME on program teams, influencing cross-functional decisions and overall development strategy
• Collaborate with CMC, Supply chain, QA and RA functions to support maintenance of product compliance, shelf life, and change control procedures
• Lead cross-functional coordination to plan and deliver timely, high-quality responses to CMC regulatory information requests
• Ensure all submissions meet phase-appropriate expectations and align with FDA, HC, EMA, ICH, and WHO guidelines
• Anticipate regulatory risks and proactively develop mitigation strategies to keep programs on track
• Collaborate effectively with internal teams and external partners including CDMOs to generate high quality source documents
• Guide late-stage development planning, including process characterization, PPQ, and readiness for commercial filings
• Bring a clear, proactive, solution-oriented mindset with the attitude to manage competing priorities
• Thrive in a fast-paced biotech environment where agility and accountability matter
• Contribute to a culture of collaboration, transparency, and continuous improvement

Qualifications:

• MS or PhD in life sciences with 10+ years of experience in a biologics focused CMC role and a minimum of 5+ years of direct regulatory CMC experience
• Strong command of cGMPs, biologics development (manufacturing, release, stability) and associated global regulatory expectations. Experience with drug device combinations (e.g., prefilled syringes, auto injectors) is preferred
• Proven track record of leading global CMC submissions and preparing briefings for milestone interactions with global health authorities (FDA, EMA etc.)
• Broad experience across development stages from early development through late stage and commercialization; Hands-on experience with BLA CMC submission is ideal
• Working knowledge of drug substance and drug product CMC development, including process, analytical development, QC, and shelf-life strategy
• Demonstrated ability to operate strategically while staying close to overall regulatory planning and execution
• Experience building alignment across teams (CMC, QA, Supply chain, QA, RA and PM) in a fast-paced biotech environment
• Strong scientific and communication skills with operational experience in tracking multiple activities, deliverables, and timelines

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA, is $213,000-240,000 for Director and $255,00-286,000 for Senior Director. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Job Title: Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)        

Location: Hybrid – Waltham, MA required to be in-office 3 days/week. 

Position Overview: 

We are seeking an experienced and motivated MSAT (Manufacturing Science and Technology) leader to lead downstream late-stage and pivotal enabling optimization, scale-up and transfer of manufacturing activities. In this role, the ideal candidate will be responsible for process development, troubleshooting production issues, data analysis, and ensuring compliance with regulatory standards to maintain product quality. The successful candidate will be involved in late-stage drug substance manufacturing and process validation activities in support of BLA filing. This role involves working in a fast-paced environment and drafting high quality reports, finalization of source documents and active participation in writing regulatory submissions. You will be an integral part of a growing team with an opportunity to contribute towards developing best in class biotherapeutics.  

Key Responsibilities:

• Oversee the transfer of manufacturing processes from late-stage development to large-scale production at the CDMOs for multiple programs.
• Work with CDMOs to identify gaps and implement improvements towards enhancing product quality, robustness, and cost-effectiveness with line of sight to commercial manufacturing.
• Build strong relationships and partner cross functionally with process development, analytical, formulation, quality, regulatory and program management.
• Oversee GMP manufacturing campaigns ensuring seamless execution, timely completion and handoff to drug product manufacturing teams.
• Partner with late-stage process characterization and MSAT teams and develop robust control strategy enabling successful PPQ DS campaigns
• Serve as person-in-plant (PIP) during drug substance manufacturing campaigns.
• Partner with stakeholders to support timely approval and execution of reports, batch records, in-process sampling plans, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.
• Support regulatory filings by authoring high quality reports enabling timely submissions for multiple jurisdictions (INDs, CTAs).
• Perform MFG/MSAT risk assessment activities in a phase appropriate manner ensuring proper measures are in place in support of production and filing requirements.
• 20-25% travel in support of manufacturing activities at CDMOs.

Qualifications:

• Master’s or a PhD degree in biochemistry, biochemical engineering, biotechnology or equivalent with at least 8 years of relevant experience developing, scaleup, and transfer of downstream processes for biologics.
• Significant experience managing manufacturing in an MSAT environment. Direct hands-on experience with monoclonal antibodies is a plus.
• Expertise in purification process optimization with an emphasis on scale-up, scale-down models, process robustness, facility fit and overall commercial readiness.
• In depth knowledge of CMC, quality and compliance, as well as regulatory aspects of biopharmaceutical development and life-cycle management.
• Must have a solid understanding of all downstream unit operations, process parameters, product quality, and troubleshooting strategies enabling successful execution of phase appropriate manufacturing campaigns.
• Demonstrated track record of successful tech transfers to CDMOs with an eye towards late stage and commercial process development.
• Must have direct experience or exposure to transition of processes from early stage to late stages such as process characterization, FMEA and PPQ campaigns, with emphasis on phase appropriate control strategy.
• Direct experience in design-of-experiments (DoE) and robust data analysis via industry standard statistical tools.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Self-starter with a strategic mindset and ability to thrive in a fast-paced, collaborative environment.      

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA, is $175,000 to $200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.