We are seeking a dynamic and experienced MSAT Associate Director to support late-stage development through launch/commercialization activities. Central to success will be engaging with CDMO(s) to deliver processes that enable robust production of Drug Substance (DS) for monoclonal antibodies. This interdisciplinary position will provide expertise across cell line, cell culture, purification, and formulations, including scale-up from lab to manufacturing scale. 

Embedded in the Drug Substance Development and Manufacturing team, this position will be a member of an integrated Development, Manufacturing & Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain.  

Key Responsibilities

• Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment
• Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
• Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners
• Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations
• Analyze process and manufacturing data to understand and optimize process performance
• Develop process characterization and PPQ strategies and documentation
• Support regulatory activities including submissions and site inspections from preparation through execution
• Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness
• Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements
• Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team
• Author and review internal procedures, reports, and presentations, as needed

Ideal Candidate

• PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience
• 7+ years of biologics development and manufacturing experience
• Experience with late phase development and commercialization of monoclonal antibodies within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.)
• Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and validation/PPQ, including person in plant and pre-approval inspection support
• Experience with process and economic modeling of DS manufacturing processes
• Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain
• Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
• Ability to multi-task and keep pace with a fast-moving organization
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Availability to participate in calls across multiple international time zones
• Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, additional travel may be required to attend visits to vendors, CDMOs, etc. domestic and international travel is required

The anticipated salary range for candidates for this role will be $175,000-$195,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking an Associate Director, Analytical Development to join our team. This newly created position is a highly collaborative leadership and technical position based in our Research and Development lab in Boston.

You will manage and lead Analytical Development activities to support early to late phase programs, including monoclonal antibodies and other biologics modalities. These activities include supporting developability screening studies, method development, non-GMP analytical characterization, comparability and R&D sample testing. In this role you will be an important member of the Tech Ops team, managing multiple activities in parallel at various stages of drug development.

Key Responsibilities

• Design, develop, and implement analytical methods for the testing and characterization of biologics programs including monoclonal antibodies and other biologics modalities. The work will include partnership with contracted partners and/or internal analytical capabilities.
• Design, manage and execute experiments to support developability screening, upstream/downstream process development, process transfer, formulation studies, product characterization and comparability studies.
• Develop and execute analytical strategies with other stakeholders in support of the product and analytical method lifecycle, ensuring compliance with safety, quality, and regulatory requirements.
• Demonstrate technical excellence in method development and analytical characterization/comparability of biologics; build strong partnerships and collaborations internally and externally.
• Collaborate with cross-functional teams, including process development and R&D, to support project goals and timelines.
• Analyze and interpret complex data sets, providing clear and actionable insights and recommendations.
• Prepare technical reports, presentations, and documentation to communicate findings and progress to stakeholders.
• Author and review analytical sections of IND, IMPD, BLA, and MAA submissions.
• Stay current with industry trends, advancements to continuously improve analytical capability, methodologies and practices.

Ideal Candidate

• PhD in Analytical Chemistry, Biochemistry, or related field, with a minimum of 7 years of relevant industry experience in an analytical development role, preferred.
• Demonstrated expertise in managing analytical development initiatives for monoclonal antibodies and other biologic modalities, encompassing method development, product quality assessment, characterization, and comparability studies.
• Deep expertise in several analytical techniques such as mass spectrometry, H/UPLC (SEC, IEX, RP, HILIC,), electrophoresis (CE-SDS, icIEF) and/or biophysical methods. Experience in ELISA, bioassay and potency assays is preferred.
• Experience in working with external contract organizations (CDMO, CRO, etc.) to deliver key analytical deliverables.
• Strong problem-solving skills and the ability to lead, design, troubleshoot, and conduct complex experiments.
• Excellent communication skills with an ability to collaborate effectively across functional lines.
• Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.
• Familiarity with regulatory requirements and guidelines (e.g., FDA, ICH) related to analytical development and comparability
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 35% for company-wide meetings as well as Tech Ops team meetings.
• This hybrid role requires approximately two days per week onsite at our laboratory in Boston (Seaport area).

The anticipated salary range for candidates for this role will be $175,000 – $195,000 /year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a highly motivated and results-oriented individual to join Apogee Therapeutics in an Associate Director, Clinical Supply Chain Management role. In this position, you will be responsible for managing the end-to-end clinical supply chain for multiple clinical programs, ensuring the timely and efficient delivery of investigational products, comparators, and ancillary supplies to support global clinical studies.  This role will collaborate closely with cross-functional teams including Clinical Operations and Development, Regulatory Affairs, Manufacturing, Quality, and external partners to manage supply planning, inventory control, distribution, and logistics in compliance with regulatory requirements and Good Manufacturing Practice (GMP) standards. The position is fully remote and reports to a senior member of the Clinical Supply Chain management team.

Key Responsibilities

• Strategic Supply Chain Planning:
• Develop and implement clinical supply strategies to meet study timelines for complex programs that require multinational interactions by reviewing clinical trial synopsis’ and/or protocols to understand IMP supply and demand requirements.
• Prepare demand forecast(s) using simulation and/or forecasting tools, ensuring changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements are considered.
• Partner with Clinical Operations and other stakeholders to determine demand assumptions, such as number of patients and clinical sites, countries/regions, enrollment rates, etc.
• Collaborate with manufacturing to develop drug product delivery schedules to meet demand.
• Optimize supply chain operations to minimize waste and ensure availability of investigational medicinal products (IMP) and materials while maintaining a low risk profile.
• Establish SOP’s and work instructions required to manage clinical supply.

• Clinical Supply Management:
• Oversee the procurement, packaging, labeling, distribution, and return of clinical trial materials, ensuring quality standards and regulatory compliance.
• Manage the label development process.
• Manage vendor relationships for outsourced supply chain services, including distribution centers, packaging vendors, and courier services.
• Develop IRT User Requirement Specifications and conduct User Acceptance Testing.
• Conduct supply chain risk assessments, proactively identifying and mitigating potential disruptions to supply continuity.
• Inventory & Distribution Oversight:
• Maintain inventory management systems to ensure accurate tracking and traceability of all clinical materials.
• Monitor inventory levels at depots and clinical sites through the life of a trial and coordinate resupply efforts to prevent stockouts or overages.
• Ensure timely and compliant distribution of IMP to clinical trial sites globally, adhering to country-specific regulations and customs requirements.
• Regulatory Compliance & Quality Assurance:
• Ensure compliance with all regulatory guidelines (e.g., FDA, EMA, ICH) and Good Distribution Practices (GDP) across all clinical supply chain activities.
• Support regulatory inspections and audits by maintaining thorough documentation of supply chain activities.
• Collaborate with Quality Assurance to manage deviations, CAPAs, and continuous improvement initiatives.
• Leadership & Cross-functional Collaboration:
• Lead and mentor one or more clinical supply chain professionals, providing direction, training, and development opportunities.
• Serve as a key point of contact with multiple functional areas and act as a liaison between internal departments and external partners to ensure alignment on clinical supply chain goals and timelines.
• Participate in cross-functional project teams to drive supply chain efficiencies and resolve challenges as they arise.

Ideal Candidate

• S/M.S. degree in Supply Chain Management, Logistics, Pharmaceutical Sciences, or related field with 12+ years of relevant experience in supply chain management and 5+ years in a leadership role. Certification in Supply Chain Management or Project Management a plus
• Experience with inventory and supply chain management for complex global clinical trials using Microsoft Excel based models and SaaS forecasting tools
• Operations experience in a biotech or pharmaceutical company, start-up experience a plus
• Third-party selection and management experience is required
• Knowledge of import/export requirements and significant experience with international clinical supply
• Working knowledge of the International Conference on Harmonization (ICH) guidelines, the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP)
• Proven ability to manage multiple projects, proactively identify and mitigate risks, and resolve issues using strong attention to detail and problem-solving skills
• Experience developing and managing program budgets
• Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity
• Strong knowledge of Microsoft Office, including Excel and PowerPoint, and Smart Sheet
• Excellent communication and influencing skills, strong collaboration skills
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
• Ability and willingness to travel up to 15% (domestic and internationally) including a minimum of 2 times per year for All Hands meetings

The anticipated salary range for candidates for this role will be $170,000-$190,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking an Associate Director to join the QC Analytical Sciences team in Analytical Development & Quality Control to lead the execution and provide technical and operational oversight of analytical testing to support product development and quality control activities across Apogee’s pipeline. This role focuses on performing and supporting QC testing, method lifecycle activities, and data review to ensure compliance with cGMP and regulatory requirements. Working closely with cross-functional teams and external partners, this individual will be an important member of the TechOps team, contributing hands-on expertise to product release, stability programs, and regulatory submissions across the development pipeline, by managing multiple parallel activities at all stages of product development.

Key Responsibilities

• Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations.
• Partner with global and cross-functional teams to ensure successful implementation of harmonized methods.
• Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements.
• Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues.
• Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines.
• Generate and review technical documents, including protocols, reports, and method lifecycle documents.

Ideal Candidate

• Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field)
• 7+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development (GMP experience required)
• Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology
• Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation
• Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections
• Excellent communication skills with an ability to collaborate effectively across functional lines
• Ability to work independently and multi-task in a fast-moving organization
• Availability to participate in calls across multiple international time zones
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

The anticipated salary range for candidates for this role will be $165,000 - $185,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a Director, Drug Product Development to develop protein drug product presentations and processes, oversee tech transfer to and manufacturing at CDMOs, and deliver robust drug product supply for clinical trials and launch/commercialization. Reporting to the VP of Formulation and Drug Product Development, this position requires deep expertise in process development, aseptic manufacturing for prefilled syringes (PFS), combination product development, and compliance, while fostering collaboration across teams and external partners. This person will be a subject matter expert in drug product manufacturing, including PFS, within the CMC organization, providing strategic guidance and technical leadership across cross-functional teams.

Embedded in the Formulation and Drug Product Development team, this position will be a member of an integrated Development, Manufacturing & Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain. 

Key Responsibilities 

• Serve as a subject matter expert in PFS process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams
• Develop late-phase and commercial launch strategy for PFS development and manufacturing
• Oversee drug product tech transfer, process development, and GMP manufacturing operations including person in plant support
• Manage drug product CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members
• Support phase-appropriate strategies for drug product development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness
• Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies
• Collaborate with drug product development and device teams to develop drug product presentations in vial, PFS, autoinjector, and advanced delivery technologies
• Analyze manufacturing data and identify opportunities for process improvement and optimization
• Support formulation and co-formulation development for protein therapeutics, including antibodies
• Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations
• Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.)

Ideal Candidate 

• Minimum of 10 years industry experience in drug product development and manufacturing
• 5+ years of experience in clinical and/or commercial Good Manufacturing Practice (GMP) operations for PFS drug products, ensuring regulatory compliance and operational excellence across all phases of manufacturing
• Demonstrated leadership in GMP manufacturing of combination products
• PhD in relevant discipline (e.g. chemical engineering, biochemical engineering, chemistry or related field) or commensurate years of education and experience
• Proven expertise in biologics drug product process development and aseptic manufacturing, preferably with a focus on monoclonal antibodies
• Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations
• Experience with process performance qualification (PPQ) and commercialization of biologics
• Experience with pre-approval inspection (PAI) readiness and support is preferred
• Experience with drug product process extractables / leachables risk assessments is preferred
• Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, clinical development, clinical operations, Quality, and Regulatory
• Excellent communication skills with ability to clearly and concisely convey information to various stakeholders and cross-functional teams
• Availability to participate in calls across international time zones
• Position requires up to 25% travel including travel to domestic and international sites. In person attendance at Apogee All Hands meetings is required, typically held twice per year.

The anticipated salary range for candidates for this role will be $210,000 to $235,000 year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.