About the Position 

The Associate Director, Drug Substance, Biologics, will provide technical, strategic and hands-on operational leadership for all CMC activities related to drug substance development and manufacturing, with a primary focus on Biologics at all stages of development (IND-enabling to commercialization).

The Associate Director, Drug Substance, will be responsible for overseeing the process development, manufacturing and release of drug substances at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug substance manufacturing (either cell culture or downstream purification), strong technical problem-solving abilities, and proven experience managing complex manufacturing operations with external partners. You will play a critical role in accelerating our mission of bringing new treatments to patients faster and more efficiently.

Responsibilities

Development and Manufacturing Strategy, Operations and Oversight

• • Lead drug substance manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints.
  • Serve as the primary technical interface with CDMOs for drug substance manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing network.
  • Oversee cell culture and downstream purification activities related to process development and manufacturing for both microbial and mammalian expression systems. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements.
  • Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues
  • Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities.
  • Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug substance for clinical trials and commercial supply.
  • Lead technical assessments and qualification of new CDMOs for drug substance manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions

Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional)

• • Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.
  • Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.
  • Partner closely with Drug Product Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Program Management leads to ensure seamless integration of manufacturing activities into overall program execution.
  • Collaborate with procurement to ensure timely contracting for drug substance manufacturing.

About You 

• MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.
• 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug substance manufacturing (either cell culture or downstream purification)
• Demonstrated track record of successfully managing drug substance manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.
• Technical expertise in either cell culture or downstream purification for process development, manufacturing, process characterization and process validation for biologics.
• Extensive experience working with CDMOs, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.

Total Compensation Range: $185,000 - $235,000

About the Position 

We are seeking a highly motivated, self-driven and detail-oriented Associate Director of Analytical Development and Quality Control to join our CMC team.  This role will provide broad exposure across Formation Bio’s portfolio, requiring the ability to flex between small molecule and biologics programs at different phases of development in an outsourced development model, requiring strong technical skillset, vendor management, and the ability to balance scientific rigor with program timelines.

You will play a key role in providing technical leadership as a subject matter expert for the development, optimization, and validation of drug substance and drug product analytical methods to support outsourced development and manufacturing of small molecule and biologics programs including but not limited to proteins, monoclonal antibodies, and vaccines. In this role you will also oversee all Formation Bio stability programs and closely collaborate with CMC, QA, and Regulatory teams.

Responsibilities

• In close collaboration with CDMOs and contract testing laboratories, lead development, optimization and validation of phase-appropriate analytical methods for small molecule and biologics drug substances and drug products.
• Manage testing (in-process, release, stability) at CDMOs and contract testing laboratories.
• Provide technical oversight for method transfers, comparability assessments, and laboratory readiness.
• Lead selection, qualification, and ongoing performance management of external analytical vendors.
• Oversee and manage Formation Bio’s stability studies across all programs, including review and approval of stability protocols and review and trending of stability data to support shelf-life and retest dating. Track and publish stability program metrics. Act as the primary contact for stability-related inquiries.
• Oversee and manage Formation Bio’s critical reagents and reference standards inventory and testing.
• Lead investigations of release and stability OOS and OOT results, deviations, CAPAs and change controls.
• Author and review analytical sections of CMC documents, including protocols, reports, and regulatory submissions.
• Author and review of SOPs and work instructions.
• Closely collaborate with CMC, QA, and Regulatory teams.

About You 

• Analytical Chemistry, Biochemistry, Molecular Biology, or a related discipline Master’s degree with 5+ years or Bachelor’s Degree with 8+ years of relevant small molecule and biologics analytical development and QC experience.
• Proven ability to operate effectively in a fast-paced, virtual, and outsourced development environment.
• Highly organized with a track record of managing multiple priorities across programs in an outsourced development model.
• Strong scientific judgment with the ability to independently assess data quality, identify risks, and recommend mitigation strategies.
• Ability to communicate complex analytical concepts clearly to both technical and non-technical stakeholders.
• Collaborative mindset with a strong sense of ownership and accountability.
• Extensive hands-on experience developing, optimizing, and validating analytical methods for release and stability testing of small molecules and biologics.
• Hands-on experience with analytical methods pertinent to bilogics (qPCR, IEF, UHPLC, MS, CE, SDS-PAGE, ELISA, peptide mapping, glycan analysis, etc.) and small molecules (UHPLC, IC, GC, IR, UV, KF, PSD, dissolution, etc.).
• Experience with authoring and reviewing technical documents such as test methods, method development reports, validation protocols, validation reports, specification justification reports, retest and shelf-life memos, and SOPs.
• Experience with designing stability studies and performing stability data trending according to applicable guidances.
• Strong working knowledge of Smartsheet and JMP.
• Thorough understanding of ICH, FDA, EMA guidances and GMP requirements governing process development, manufacturing, and stability.
• Ability to travel domestically and internationally up to 25% of the time. 

Total Compensation Range: $177,000 - $235,000

About the Position 

The Associate Director, Bioanalytical will lead bioanalytical strategy and delivery for assigned programs, working across nonclinical and clinical teams to ensure assays are fit for purpose and support key development decisions. The role will oversee external bioanalytical partners and drive execution for PK/TK, metabolites as applicable, biologics bioanalysis, and immunogenicity, including assay approach selection, validation strategy, sample analysis oversight, data review, and submission-ready documentation. In partnership with Clinical Pharmacology, DMPK/Nonclinical, Clinical Operations, Regulatory, and data teams, this role will help scale Formation Bio’s Trial Engine by standardizing bioanalytical workflows, improving traceability, and enabling consistent, analysis-ready bioanalytical outputs across programs.

Responsibilities

• Lead bioanalytical strategy and delivery for assigned programs across small molecules and biologics, aligned to clinical questions and decision points
• Define assay plans and validation approaches (fit-for-purpose through full validation) for PK/TK, metabolites as applicable, biologics bioanalysis, and immunogenicity
• Manage bioanalytical CROs and specialty labs for assigned workstreams: contribute to partner selection, define scopes, set timelines, and monitor performance, quality, and budget
• Oversee end-to-end bioanalytical execution: protocols, validation reports, sample analysis, data review, and final reports to support program decisions and filings
• Own day-to-day BA operating processes for assigned programs: assay lifecycle tracking, method transfer planning, issue triage, deviation management, and CAPA follow-up with vendors
• Ensure data quality and audit readiness for assigned deliverables through strong documentation practices, traceability, and alignment to regulatory guidance and internal standards
• Partner with Clinical Pharmacology and Clinical Development on study design inputs, sampling strategies, analyte panels, and interpretation of exposure and immunogenicity implications
• Coordinate with Clinical Operations on sample logistics (kits, handling, stability, chain of custody, reconciliation) and resolution of operational issues impacting bioanalysis
• Collaborate with Regulatory Affairs by drafting/reviewing submission components and providing technical input to support IND/CTA and NDA/BLA/MAA activities
• Align with DMPK/Nonclinical on bioanalytical approaches across studies and support translational PK needs
• Work with Biostatistics/Data Science to enable clean data transfers, consistent formats/metadata, and analysis-ready datasets
• Support diligence and asset evaluation by reviewing bioanalytical packages, identifying gaps/risks, and proposing pragmatic remediation plans
• Contribute to Trial Engine scaling by helping standardize templates, workflows, and reporting conventions that improve speed and consistency across programs

About You 

• PhD in a relevant field with 7+ years of bioanalytical experience in biopharma, including clinical-stage support, or a relevant undergraduate degree with 10+ years of experience
• Lead bioanalytical strategy and execution for assigned preclinical and clinical programs across small molecules and biologics
• Deep LC–MS/MS expertise for PK/TK, troubleshooting, and ISR
• Familiar with biologics bioanalysis and immunogenicity (ADA/NAb) approaches and interpretation
• Strong working knowledge of bioanalytical regulatory expectations and submission-quality documentation
• Lead CRO/vendor execution for assigned workstreams; support partner selection and governance as needed
• Comfortable operating in a fast-paced, cross-functional environment with multiple concurrent priorities
• Clear communicator who can translate technical detail into program-relevant recommendations
• Preferred: Experience functioning as part of a clinical study team to integrate tradeoffs between vendor selection, development speed, assay quality and performance, and applicability of method to deliver value to program overall
• Preferred: Familiarity with GCP/GCLP expectations and audit/inspection readiness for clinical bioanalysis
• Preferred: Experience shaping sample logistics (kits, stability, chain of custody) and data flow into filings

Total Compensation Range: $177,500 - $232,000

About the Position 

The Associate Director, Drug Product, will provide strategic and hands-on operational leadership for all CMC activities related to drug product development and manufacturing, with a primary focus on sterile injectables (lyophilized and liquid) at all stages of development (IND-enabling to commercialization).

The Associate Director, Drug Product, will be responsible for overseeing the formulation development, fill-finish, packaging, and release of drug products at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug product manufacturing, strong technical problem-solving abilities, and proven experience managing complex manufacturing operations with external partners. You will play a critical role in accelerating our mission of bringing new treatments to patients faster and more efficiently.

Responsibilities

Development and Manufacturing Strategy, Operations and Oversight

• Lead drug product manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints.
• Serve as the primary technical interface with CDMOs and contract manufacturing organizations for drug product manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing networks.
• Oversee formulation, aseptic fill-finish, lyophilization (if applicable), visual inspection, labeling, and packaging operations for drug products. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements.
• Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues
• Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities.
• Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug product for clinical trials and commercial supply.
• Lead technical assessments and qualification of new CDMOs for drug product manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions

Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional)

• Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.
• Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.
• Partner closely with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Project Management leads to ensure seamless integration of manufacturing activities into overall program execution.
• Collaborate with procurement to ensure timely contracting for drug product manufacturing.

About You 

• MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.
• 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug product manufacturing, formulation development, and fill-finish operations.
• Demonstrated track record of successfully managing drug product manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.
• Technical expertise in aseptic fill-finish operations, lyophilization processes, formulation development, stability programs, and drug product characterization for biologics.
• Extensive experience working with CDMOs and contract manufacturing organizations, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.
• Strong knowledge of cGMP regulations, FDA and EMA guidelines, ICH quality guidelines, and regulatory expectations for drug product manufacturing.
• Experience authoring and reviewing CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing and validation activities.
• Strong project management skills with demonstrated ability to manage multiple manufacturing programs simultaneously, meet aggressive timelines, and navigate competing priorities.
• Excellent communication and interpersonal skills with ability to influence and build strong relationships with internal stakeholders and external manufacturing partners.
• Willingness to travel domestically and internationally (approximately 20-30%) to manufacturing sites for audits, manufacturing oversight, and technical meetings.

Total Compensation Range: $177,000 - $235,000