Director/Sr. Director, Quality Assurance (Small Molecule)

Job Summary

This individual will be a key member of the internal CMC Team and will support early and late phase development of the company’s experimental therapies.

 Responsibilities:

• Collaborate with the rest of the CMC Team and a group of external expert consultants to identify appropriate formulations and processes to support the development of the company’s products.
• Initiate, evaluate, and negotiate contracts and manage CROs for formulation development and Drug Product GMP manufacture, as well as provide in person technical support, as needed, to oversee various manufacturing/scale-up/validation activities and provide technical expertise to trouble-shoot manufacturing/packaging process issues.
• Support the development and validation of analytical methods and share responsibility for multiple long-term stability studies for Drug Product.
• Collaborate with Quality Assurance to ensure the quality of the company’s manufactured products and communicate appropriately to cross-functional teams and senior management.
• Participate in the generation and finalization of technical reports and regulatory documents in the areas of responsibility.
• Develop long-term plans, including timelines, budget and API requirements to support drug product development and clinical trial material manufacture, from early stage through to process validation. Responsibilities will include continuing to build internal formulation development capabilities, including continuing to grow the capabilities of Arcus’s formulation development laboratory and training junior scientists.

This position will report to the VP of Preclinical and Small Molecule Pharmaceutical Development. 

 Qualifications: 

• Ph.D. in pharmaceutical sciences or a Pharm.D. degree.
• Deep understanding of the scientific disciplines that underlie the physical and physiological behavior of various drug formulations for oral and parenteral delivery, as well as a working knowledge of the regulatory guidelines relevant to GMP work.
• At least 10 years of relevant work experience in a high-quality industry environment. Emphasis on supporting early-stage development programs, up to the development of Phase 3 / commercial formulations. Experience in large-scale manufacturing will be a plus.
• Experience in the selection, contract negotiation and management of various types of CROs in support of small-molecule formulation development / DP manufacturing activities. Alternatively, the candidate will have acquired the relevant work experience by working at a relevant high-quality CRO.
• Strong writing skills, extensive experience authoring technical reports and regulatory documents.
• Ability to travel occasionally, as needed, to the sites of partner CROs.