Associate Director, Chemical Development and Manufacturing Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare disease and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the companys leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. The impact you will make: Agios Pharmaceuticals is searching for a dynamic Associate Director to join our growing Process Chemistry team. We want someone who cares about this important work, and whos driven to connect to our mission of helping these patient communities. The chemist will be immersed into all aspects of small molecule/oligonucleotide development from process design to cGMP manufacturing. The role will lead activities and act as the Subject Matter Expert to solve technical challenges and develop sustainable processes to provide unhindered drug supply to patients. The chemist will significantly grow in this role gaining leadership experience in data driven process development, CDMO management, production, CMC, and regulatory submissions. What you will do: Solve technical issues relating to external drug substance manufacturing by providing technical leadership within the chemical development group. Responsible for drug substance process design, optimization, scale-up, technology transfer, and validation with a focus on clinical manufacturing; ensure relevant data is captured in reports provided by external CROs/CMOs. Serve as the drug substance technical lead on a CMC sub-team and project leadership within chemical development and DS point project point of contact with CDMOs. Identify key knowledge gaps and execute plans to ensure our process understanding is commensurate with a given programs stage of clinical development. What you bring: MS or PhD in organic chemistry or chemical engineering with 10+ years (MS) or 6-10+ years (PhD) of industry experience. Must have knowledge and understanding of organic chemistry including expert hands-on experience. Ability to navigate and be successful in a fast-paced, highly-matrixed work environment. Experience authoring regulatory documentation in support of clinical trials (IND, QOS, IMPD, Briefing Booklets, etc) and submissions (NDA and MAA). Strong verbal and written communication skills. Preferred Qualifications: Experience managing CROs and CMOs. Experience with oligonucleotide manufacturing and development. Experience with and demonstrated application of advanced technologies to enable and accelerate development including flow chemistry, computational modeling, PAT, DOE, and/or process modeling. Previously served as a drug substance lead/SME for clinical development programs. Ability to travel approximately monthly and bimonthly. Work Location: Location Specific Hybrid: This role requires some work onsite at our Cambridge Headquarters as needed. Hybrid schedules vary but are generally less than 3 days per week onsite. Regular conversations with manager are encouraged to ensure alignment on in-person presence/expectations. Employees in this role are expected to live within a commutable distance to the office and some travel may be required commensurate to the above job description and/or to attend team meetings and other company events. What we will give you: Deliberate Development: Your professional growth is one of our top priorities. Flexibility: Were all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When youre at your best, were at our best. Premium benefits package: We invest in the health, well-being 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 performance-based compensation: This includes both short- and long-term incentives that are connected to our business strategy. 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. Were continuously looking to improve the inclusivity of our workforce. Commitment to community: Were 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. #J-18808-Ljbffr