Anokion is an innovative immune tolerance company focused on providing a more effective approach to treating autoimmune disease. Our proprietary immune tolerance platform features proteins, or antigens, that are engineered to deliver precise, targeted disease therapy, without the side effects of broad immunosuppression. Anokion’s antigen-specific platform can be translated to virtually any antigen-mediated disease, with widespread potential across multiple clinical applications. Anokion is based in Cambridge, MA in the vibrant hub with several other innovative biotech and pharmaceutical companies.
The position of Principal Scientist, Process Chemistry at Anokion will have accountability for a broad range of development activities for the synthesis, scale-up and manufacturing of active pharmaceutical ingredient (API) internally and at CMOs leading to GMP manufacturing. The position reports directly to the Head of Technical Operations and will be a fully engaged member of the CMC Leadership Team. In this role, he/she will collaborate across the organization, including Research Chemistry, Analytical Sciences, Pharmaceutical Development, Quality and Regulatory Affairs. Our Process Chemistry effort is mostly conducted externally through a network of CMOs/CROs and this role will be responsible for these interactions. The successful candidate will also provide Process Chemistry subject matter expertise (SME) input into the writing and review of regulatory submissions and take part in Agency interactions. This position is the bridge between internal research and external manufacturing, and hence, knowledge of scale-up, manufacturing under GMPs, troubleshooting during process transfer and scale-up, communication and technical management at the CMO are key requirements.
Work closely with R&D colleagues to seamlessly move development candidates from research to CMC stage with diligent scale-up activities leading to GMP manufacturing
Ensuring that all development and manufacturing activities are conducted in a manner consistent with regulatory requirements while integrating quality by design (QbD) and quality risk management principles into the development of the API process
Working with project teams to identify drug substance requirements, managing and optimizing aggressive project timelines, overseeing the development of technical solutions to ensure that API processes can be successfully demonstrated and delivered
Working with scientists to maintain standards for all laboratory records, internal reports, patents and external communications
Leading the preparation of scientific reports for all branches and levels of the organization and its collaborators
Overseeing the preparation and review of development history, manufacturing batch records and regulatory documents; assisting in the writing of process descriptions for the CMC section of regulatory documents
Experience in conducting early and late phase development (IND/CTA through late phase filings)
Provide expertise and input for RAFT polymer process designs
Willingness to provide on hands on polymer synthesis in chemistry lab setting
PhD in Chemistry (or related field) with 10+ years in biotech or pharmaceutical environment with emphasis on large scale chemical synthesis preferably synthetic polymers; advanced knowledge of RAFT and other polymerization technologies
Strong understanding of pharmaceutical API manufacturing; track record of moving projects from lab scale to GMP manufacturing
A strong background in synthetic organic chemistry with a track record of innovation and recognized as an expert in the area of chemical synthesis.
Experience in technical process transfer to external CROs and management of project timelines and budget with the CROs
Extensive experience in chemical development, preparing batch records, CMC sections for INDs/CTAs
Proven management skills and a demonstrable collaborative mindset
Team player with experience working in matrixed environments
Proven leadership skills and experience managing high-performing research teams
Strong written and oral communication skills