Associate Director, Analytical Development, CMC

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 genetically defined diseases – 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 company’s 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, Analytical Development, CMC to join our growing CMC team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Associate Director, Analytical Development should be highly motivated and a fast learner who will be a key stakeholder within analytical development team to help build and lead the analytical development function within CMC and hands-on contributor to the overall CMC strategy of drug development at Agios. The ideal candidate is expected to support analytical development of small molecule and siRNA oligonucleotide candidates from Phase I through NDA for both drug substances and drug products. Specifically, candidate will demonstrate a proven track record of managing CROs and CMOs successfully in developing methods, quality control strategy and testing of small molecule and oligonucleotide drug candidate to support Phase I to commercial launching.

What you will do:

• Guide and collaborate with CRO to design and perform robust method development and validation employing phase-appropriate approaches (pre-clinical through Phase 3) for assay, purity and dissolution methodologies, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization as applicable for small molecules and oligonucleotide focuses
• Develop phase-appropriate quality control strategy for small molecule and oligonucleotide drug substance and drug product
• Manage product stability study programs
• Closely coordinate with QA and Regulatory, as well as other CMC functions, Clinical and Toxicology regarding safety-related questions on APIs, components of APIs and formulations and materials used in processing
• Serve as the CMC representative on cross-functional project teams
• Design and execute experiments to fully characterize the oligonucleotide drug substance and drug product materials.
  
  

What you bring:

• PhD in analytical chemistry with 3+ years’ or BS/MS with 5+ years’ analytical development experience in the pharmaceutical industry
• Experience with regulatory filling including, e.g IND/IMPD/NDA/MAA submissions, is desired.
• Experience in CMC project management as well as analytical laboratory leadership and experience is a plus.
• Excellent scientific knowledge in analytical chemistry and organic chemistry with small molecule and oligonucleotide focus.
• Strong mass spectrometry background, experience with method development for identification, impurity profiling, and MS/MS characterization of oligonucleotides using high-resolution mass spectrometry.
• Strong analytical development knowledge/experience including method development, experimental design, lab investigation, statistical analyses and stability trending for small molecule and oligonucleotide drug substance and drug product.
• Effective verbal and written communication skills
• Experience managing CROs and CMOs
• Experience drafting, reviewing and submitting required documentation pertaining to the cGMP environment
• Proven track record of implementing phase appropriate quality control strategies
• Ability and track record of successfully working in cross-functional teams to progress projects as a representative of CMC team
• Ability to navigate and be successful in a fast-paced, matrixed work environment
  
  

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.
• 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. 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.