Senior Director, Chemical Development & Manufacturing, CMC

Senior Director, Chemical Development & Manufacturing, CMC

Who we are:

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built. To learn more, visit www.agios.com and follow Agios on LinkedIn and X.

The impact you will make:

Agios Pharmaceuticals is searching for a strategic and scientifically accomplished Senior Director, Chemical Development & Manufacturing to join our CMC and Technical Operations team. This leader will set and execute drug substance development and manufacturing strategy across a portfolio centered on small-molecule therapeutics while building fit-for-purpose capability for siRNA and oligonucleotide programs. The role will lead process development, scale-up, technology transfer, external manufacturing, regulatory CMC, and lifecycle activities from candidate selection through commercialization. The successful candidate will combine deep small-molecule API expertise with meaningful experience in, or strong technical fluency across, nucleic acid therapeutics and will translate that breadth into reliable supply, sound decisions, and high-performing partnerships.

What you will do:

• Lead small-molecule drug substance strategy. Define phase-appropriate CMC plans from candidate selection through commercial lifecycle, including route design, process optimization, scale-up, control strategy, validation, and continuous improvement.
• Deliver robust API processes. Drive process chemistry and chemical engineering solutions that improve manufacturability, quality, yield, safety, sustainability, cost, and supply reliability.
• Provide end-to-end technical ownership. Establish physicochemical, solid-form, impurity, raw-material, and process understanding needed to support toxicology, clinical, registration, and commercial supply.
• Direct external development and manufacturing. Select, qualify, and govern CROs and CDMOs; set technical expectations; oversee campaign readiness and execution; and resolve complex technical, quality, schedule, and supply issues.
• Lead technology transfer and commercialization. Oversee process transfer, process characterization, PPQ readiness, validation, comparability, and lifecycle management across internal and external networks.
• Build siRNA and oligonucleotide capability. Shape phase-appropriate development and manufacturing strategies for oligonucleotide drug substances, including siRNA.
• Apply modality-specific technical judgment. Guide external partners across oligonucleotide synthesis, purification, conjugation, impurity control, analytical characterization, scale-up, and supply strategy while recognizing platform-specific risks and controls.
• Represent CDM on cross-functional teams. Partner with Research, DMPK, Toxicology, Analytical Development, Formulation Development & Manufacturing, Quality, Regulatory Affairs, Supply Chain, Clinical Supply, and program leadership.
• Lead regulatory CMC delivery. Author, review, and approve drug substance content for INDs, IMPDs, NDAs, MAAs, health authority responses, and post-approval submissions; support inspections and regulatory interactions.
• Support portfolio and business decisions. Assess manufacturability, scalability, technical risk, cost, intellectual property considerations, and supply implications for internal programs and external opportunities.
• Build talent and organizational depth. Lead, coach, and develop scientists, engineers, and technical leaders; establish clear accountability, succession capability, and an inclusive culture of rigorous science and executional excellence.
• Own plans and resources. Develop operating plans, budgets, capacity strategies, risk assessments, and portfolio priorities for the function and its external network.

What you bring:

• Ph.D. in organic chemistry, process chemistry, chemical engineering, pharmaceutical sciences, or a related discipline, with typically 15+ years of relevant pharmaceutical or biotechnology experience. An equivalent combination of education and experience may be considered.
• Deep expertise in small-molecule drug substance process development and manufacturing, with a record of advancing programs from preclinical development through late-stage, registration, and commercial supply.
• Demonstrated leadership in synthetic route design, impurity control, process scale-up, process characterization, technology transfer, validation, and lifecycle management.
• Strong experience selecting, managing, and governing global CRO and CDMO relationships, including oversight of cGMP manufacturing and complex technical investigations.
• Working experience or strong technical fluency in oligonucleotide and siRNA development and manufacturing, such as solid-phase synthesis, purification, conjugation, analytical characterization, impurity control, or specialized external manufacturing.
• Ability to develop modality-appropriate strategy without applying small-molecule assumptions where oligonucleotide-specific science, quality attributes, or manufacturing controls are required.
• Broad knowledge of global regulatory CMC expectations and experience preparing drug substance sections of INDs, IMPDs, NDAs, MAAs, or comparable submissions and responses.
• Proven success leading multidisciplinary teams and influencing decisions in a fast-paced, highly matrixed environment.
• Clear, concise written and verbal communication, sound business judgment, and the ability to translate complex science into decisions, risks, and executable plans.
• A leadership style that promotes scientific rigor, accountability, candor, inclusion, collaboration, and deliberate development of people.

Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

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. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

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. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.

• 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.

• The current base salary range for this position is expected to be between $229,562 and $344,342 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.

• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.

• 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.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.