Manager, Analytical CMC

Summittherapeutics; United Kingdom; Remote; GBP 60,000 - 80,000

Job description

The Manger, Analytical CMC is an enthusiastic analytical chemist that will work within a vibrant development environment as we approach the commercialization of our lead asset, Ivonescimab. The ideal candidate will have proven technical ability in the analytical development and quality control of biologics, preferably incorporating the analysis of monoclonal antibodies, and ideally including experience in outsourcing of analytical services. The role will involve working with the Summit analytical group and other CMC, quality, and regulatory stakeholders in drug substance and product development, to provide operational and technical oversight on all analytical activities across the organisation and to support the supply of required material/information to achieve Summit milestones. This position will be required to build operational relationships with Summit CDMOs and work in close collaboration internally and externally to allow successful CMC deliverables.

Role and Responsibilities:

1. Contribute to and have accountability for all Summit CMC activities, with focus on the design of new or improved analytical methods and technical troubleshooting to support drug substance and product development; raw materials; impurity control strategies, specifications etc.
2. Support phase-appropriate analytical method development and validation, product characterization, comparability studies, QC and stability testing, and method transfers to or between external CDMOs for drug substance and drug product (DP)
3. Assist in planning and execution of analytical activities
4. Assess and manage analytical risks arising from manufacturing or process changes
5. To develop effective working relationships with Summit project team members and external Contract Manufacturing Organization (CMO)
6. Assist in generation, update and/or review of regulatory filings
7. Support analytical team objectives whilst providing clear and concise updates of results and reports to the project team, including Head of CMC, and drug substance, product development and MSAT team leaders
8. Work in close partnership with analysts, formulation scientists, QA, RA, supply chain, consultants, and cross-functionally
9. Support CMC sub teams and programs
10. Provide detailed analytical reports for projects and external briefing documents and publications
11. Facilitate problem-solving, contingency planning, and decision-making
12. Drive continuous improvement in our processes to reduce method failure rates and improve quality
13. Provide input in the development of internal SOPs and processes that follow ICH and GxP Guidelines
14. All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

1. MSc or PhD (or equivalent) degree in Chemistry, Pharmaceutical Science, Analytical Science or related discipline required
2. A minimum of 5+ years of biological analytical development experience, including product characterization, comparability studies, and QC testing
3. Proven technical knowledge in various analytical techniques for biological products (e.g. monoclonal antibodies) and demonstrated proficiency in, not limited to, SE-HPLC, nrCE, rCE, ELISA and cell-based assays
4. Experience in managing analytical activities, preferably including both DS and DP, at Contract Manufacturers along with early and late stage/ commercial pharmaceutical biological drug programs
5. Prior experience in supporting analytical method development and support for GMP manufacturing from early to late clinical phase
6. Awareness of analytical requirements for Process Validation ensuring appropriate analytical studies are performed and providing Process Validation (PPQ) oversight
7. Exhibit highly effective teamworking, communication (verbal and written) and influencing skills
8. Motivation and accountability to solve analytical, chemistry and drug development problems, utilizing excellent analytical thinking and problem-solving skills.
9. Good information management
10. Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
11. Understands the dynamic and requirements of working remotely in a small multi-cultural worldwide biotech company
12. A track record of working under pressure and bringing excellent quality deliverables to tight deadlines