Associate Director, Chemical Development and Manufacturing

The Impact You Will Make

Agios is seeking an experienced and dynamic Associate Director to join the Chemical Development & Manufacturing (CDM) team. This is a high-impact, senior contributor and technical leadership role that sits at the nexus of process chemistry, external manufacturing, regulatory science, and cross-functional program execution.

Technical Leadership & Process Ownership

• Serve as the DS technical SME for an assigned small molecule program, owning the end-to-end process chemistry strategy from clinical Phase through regulatory submission, validation, commercial launch, and life-cycle management.
• Lead process design, optimization, scale-up, technology transfer, and process validation campaigns at external CDMO sites; ensure manufacturing outcomes are robust, reproducible, and cGMP-compliant.
• Identify and systematically close process knowledge gaps to ensure understanding is commensurate with the program's stage of development and aligned to ICH Q8/Q9/Q10/Q11 expectations.
• Provide technical troubleshooting and root cause analysis for manufacturing deviations, OOS investigations, and process-related atypical results in collaboration with CDMO quality and operations teams.
• Champion the application of advanced development tools including Design of Experiments (DOE), process analytical technology (PAT), flow chemistry, computational process modeling, and continuous manufacturing.

External Manufacturing & CDMO Partnership

• Act as the primary technical point of contact with CDMOs and CROs for drug substance development activities; direct and review technical work conducted externally, including batch records, development reports, analytical data packages, and validation protocols.
• Manage external partner performance against technical deliverables, timelines, and quality standards; proactively escalate risks and develop mitigation strategies in collaboration with cross-functional and CDMO leadership.
• Evaluate manufacturing equipment, engineering capabilities, and production processes at CDMO sites to ensure suitability for clinical and commercial scale manufacturing; provide SME input on capital equipment decisions and facility qualification activities.
• Support the assessment and selection of CDMOs for new programs and technology transfer campaigns; conduct technical due diligence and gap analyses for prospective external manufacturing partners.

Cross-Functional Program Leadership

• Serve as the drug substance technical lead on the CMC sub-team, providing authoritative input to the integrated development plan, regulatory strategy, and program timelines.
• Collaborate closely with Analytical Development, Formulation Development, Quality, Regulatory Affairs, Supply Chain, and Clinical Operations to ensure seamless CMC execution across all program milestones.
• Lead CMC-related risk assessments, FMEA exercises, and technical review boards; provide expert scientific judgment for cross-functional decision-making.
• Mentor and support junior scientists within Chemical Development; contribute to the growth of the team's collective process chemistry expertise and institutional knowledge.

Regulatory & CMC Documentation

• Author and review high-quality CMC regulatory documents in support of global submissions including INDs, CTAs, IMPDs, NDA/MAA Module 3 sections, and post-approval variations.
• Ensure technical content across regulatory filings is scientifically sound, internally consistent, and aligned to current FDA, EMA, and ICH guidance.
• Collaborate with Regulatory Affairs to develop and execute CMC regulatory strategy for assigned programs; prepare for and contribute to pre-IND, pre-NDA, and Type B/C agency meetings as the DS technical expert.

What You Bring

• Ph.D. in Organic Chemistry, Chemical Engineering, or a closely related discipline with 6–10+ years of pharmaceutical industry experience; or M.S. with 10+ years, including increasing leadership responsibility.
• Expert command of synthetic organic chemistry and process chemistry principles, with substantial hands-on process development experience at laboratory, kilo-lab, and pilot/manufacturing scale.
• Demonstrated experience as a DS technical lead or SME on small molecule clinical development programs spanning at least one of: Phase 3 readiness, regulatory submission, or commercial launch.
• Extensive experience managing CDMOs and CROs, including technical direction of external organizations, performance oversight, and resolution of complex manufacturing and quality challenges.
• Proven authorship of CMC regulatory documents for global submissions (IND, CTA, QOS, NDA Module 3 / MAA Module 3, IMPD, eCTD) and experience supporting FDA and EMA interactions.
• Deep familiarity with cGMP principles, ICH guidelines (Q7, Q8, Q9, Q10, Q11), process validation expectations, and the regulatory framework governing drug substance manufacture and approval.
• Outstanding cross-functional collaboration skills; demonstrated ability to lead by influence in matrixed organizations and to communicate complex technical concepts clearly to both scientific and non-scientific audiences.
• Strong project management capabilities with demonstrated proficiency in prioritization, timeline management, and delivery of CMC milestones in a fast-paced, multi-program environment.

Preferred Qualifications

• Experience with advanced process development technologies: flow chemistry, PAT tools (Raman, FBRM, IR), multivariate data analysis, process modeling, or continuous manufacturing.
• Track record of applying DOE methodologies and statistical tools for process characterization, parameter ranging, and design space definition.
• Hands-on familiarity with production-scale reactor equipment, engineering design considerations (agitation, heat transfer, mass transfer), and technology transfer from bench to cGMP manufacturing.
• Experience supporting or leading commercial process validation (PV Stage 1/2/3) and the preparation of Process Validation Reports and CPV protocols.
• Prior engagement in CDMO site qualifications, facility audits, and equipment suitability assessments for DS manufacturing.
• Knowledge of particle engineering, crystallization development, and solid-form optimization relevant to drug substance physical properties.
• Ability and willingness to travel quarterly (~10%) to CDMO / partner sites domestically and internationally.

Work Location

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings.

What We Will Give You

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.