Associate Director, Formulation Development and Manufacturing
Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.
Agios Pharmaceuticals is searching for a dynamic Formulation Scientist to work in a cross functional, fast paced environment on exciting first in class molecules targeting various indications including oncology and rare genetic diseases. The ideal candidate will support preformulation work while working closely with discovery / preclinical groups, lead drug product development and the manufacture of small molecule therapeutics from Phase I through NDA.
Liaison with discovery and preclinical groups to support physicochemical characterization and formulation work for animal studies. Help develop an understanding of molecule till larger CMC group gets involved.
Guide CRO to conduct preformulation characterization and design formulations at different stages of development (pre-clinical through Phase 3)
Manage external CRO/CDMOs to prepare/manufacture drug products under GLPs and cGMPs to supply toxicology studies, clinical trials and commercial
Familiar with QBD approach to develop robust drug product
Author formulation development reports and drug product sections in IND, IMPD and NDA filings
Work collaboratively with DMPK, toxicology, pharmacology and clinical development to develop and deliver appropriate drug products for different phases of animal and human studies
Collaborate effectively with various functions of technical operations such as process chemistry, analytical chemistry to establish phase appropriate control strategy for formulations and also collaborate with QA and Supply chain to help in seamless operational execution.
Eventually, serve as a CMC leader of development projects to coordinate all CMC related development activities
PhD in pharmaceutics, chemistry, material science, chemical engineer or related discipline with 6+ years industry experience.
Excellent scientific knowledge in preformulation, material science and formulation
Effective verbal and written communication skills
Experience in managing CROs and CMOs
Experience with design and analysis of DoE’s
Experience and ability to draft drug product sections of INDs, IMPDs, and NDAs
Experience in drafting, reviewing and submitting required documentation pertaining to the development and preparation of drug products under cGMP environment
A proven track record of successful development of oral solid dosage forms
A desire to be part of a highly innovative company aimed at helping patients with serious diseases
Ability to travel both international and domestic. Travel is approximately 25%.
Experience with QbD approaches to drug product development
Experience with crossover study designs and analysis
Ability and track record of successfully leading and representing CMC function in cross-functional teams to progress projects
Ability to navigate and be successful in a fast-paced, highly-matrixed work environment