Senior Scientist, Formulation Development and Manufacturing

Senior Scientist, Formulation 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 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 Senior Scientist to join our growing Formulation Development and Manufacturing 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 Senior Scientist will lead drug product development and the manufacture of small molecule/ mRNA therapeutics across the entire development spectrum from preclinical stages through NDA, with a focus in establishing aseptic capability at Agios.

What you will do:

• Formulation design at different stages of development from pre-clinical through Phase 3
• Serve as the Formulation lead of development projects. Represent formulation in multi-functional Technical Operations project teams
• Tech transfer to external CDMOs and manufacture drug products under cGMP to supply clinical trials and commercial
• Building in house aseptic R&D capability and external CDMO network for cGMP manufacturing
• Support early stage formulation development and bring projects into IND
• Support late stage activities including registration, pre-validation and validation
• Author development reports and drug product sections in IND, IMPD, NDA and MAA filings
• Work collaboratively with DMPK, toxicology and clinical development to develop and deliver appropriate drug products for different phases of animal and human studies

What you bring:

• PhD in chemical engineering, biomedical engineering, material science, or related discipline with 5+ years pharmaceutical industry experience. MS and BS with 9+ years of experience.
• Track record of successfully leading formulation design/development and representing formulation in multi-functional CMC groups.
• Experience in managing CROs and CDMOs
• Experience in aseptic fill finish/ parental formulation development and leading project through clinical phases is a must. Strong hands-on experience in formulation and process development.
• Excellent scientific knowledge in solid state characterization, material science and formulation design
• Experience and ability to draft drug product sections of INDs, IMPDs, NDAs and MAAs. Experience in filing with mRNA is a plus
• A desire to be part of a highly innovative and fast-paced company aimed at helping patients with serious diseases
• Ability to travel both internationally and domestically, driven by project need from approximately 10 - 15%

Preferred Qualifications

• Experience in oligonucleotide/ mRNA formulation or LNP development
• Experience in oral dosage formulation development.
• Experience in preformulation development

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.