Senior Manager/Associate Director of Analytics
Posted on Apr 5, 2021 by Summit Therapeutics plc
We require an experienced and enthusiastic analytical chemist to join the CMC team to work within a vibrant development environment. The ideal candidate will have proven technical ability in analytical research and development and quality control, ideally including experience in outsourcing of analytical services. The role will involve working with the Director of Analytics and other CMC team stakeholders in API 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. Supporting both early development activities for lead candidates coming from our Discuva group, and late phase activities toward commercial supply will also be part of this role. 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.Reporting to the Director of Analytics.
Roles and Responsibilities
Contribute to all Summit CMC activities, with focus on the design of new or improved analytical methods and technical troubleshooting to support API and product development; raw materials; impurity control strategies, specifications definitions etc.
Support phase-appropriate analytical method development and validation, product characterisation, QC and stability testing, and method transfers to or between external CDMOs for API and drug product (DP).
Assist in planning and execution of analytical activities.
Assess and manage analytical risks arising from chemistry or process changes.
To develop effective working relationships with Summit project team members and external Contract Manufacturing Organisations (CMO).
Assist in generation, update and/or review of regulatory filings.
Support analytical development whilst providing clear and concise updates of your results and reports to the project team, including Head of CMC, and API and product development team leaders.
Work in close partnership with analysts, formulation scientists, GMP QA, RA, consultants, and cross-functionally.
Support CMC sub teams and programs.
Provide detailed analytical reports for projects and external briefing documents and publications.
Facilitate problem-solving, contingency planning, and decision-making.
Drive continuous improvement in our processes to reduce method failure rates and improve quality.
Provide input in the development of internal SOPs and processes that follow ICH and GxP Guidelines
Other activities as may be assigned.
Experience, Education and Specialized Knowledge and Skills
Degree, MSc, PhD (or equivalent) in Chemistry, Pharmaceutical Science, Analytical Science or related discipline.
Significant analytical development experience, including solid state and pharmaceutical characterisation, and QC testing.
Proven technical knowledge in various analytical techniques and proficient in NMR, HPLC and MS for structural determination.
Experience in managing analytical activities, preferably including both API and DP, at Contract Manufacturers along with early and late stage/commercial pharmaceutical drug programs.
Prior experience in supporting analytical method development and support for GMP manufacturing from early to late clinical phase.
Awareness of analytical requirements for Process Validation ensuring appropriate analytical studies are performed and providing Process Validation oversight.
Exhibit highly effective teamworking, communication (verbal and written) and influencing skills.
Motivation to solve analytical, chemistry and drug development problems, utilizing excellent analytical thinking and problem-solving skills.
Good information management.
Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
Understands the dynamic and requirements of working in a small company.
A track record of working under pressure and bringing excellent quality deliverables to tight deadlines.