Senior Manager CMC
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Hobson Prior are currently searching for an experienced and enthusiastic Senior Manager to join the CMC team to work within a vibrant development environment. You will have the opportunity to join a clinical-stage drug discovery and development discovering organisation who advance pioneering therapies to advance the standard of treatments for serious infectious diseases.
Please note that to be considered for this role you must have the right to work in this location.
- You will contribute to all chemistry activities, such as design of new synthetic routes, processes suitable for scale up manufacture, specifications definitions etc.
- Assist in the planning and execution of Chemistry activities.
- To define and implement API development and manufacturing strategy to fulfil project requirement.
- Assess and manage chemistry process risks arising from scale, equipment or process changes.
- To develop effective working relationships with project team members and external Contract Manufacturing Organisations.
- Management of API CDMOs to enable successful outcomes.
- Authoring/reviewing of module 3 for global submission.
- Support API syntheses development whilst providing clear and concise updates of your results to the project team.
- Drive continuous improvement in our processes to reduce the cost of goods, reduce waste and environmental impact, improve yield or improve quality.
- Work in close partnership with analysts, formulation scientists, GMP QA, RA and cross-functionally.
- Support CMC sub teams and programs.
- Provides detailed chemistry reports for projects and external briefing documents and publications
- Facilitate problem-solving, contingency planning, and decision-making.
- To provide input in the development of internal SOPs and processes that follow, ICH and GXP Guidelines
- Other activities as may be assigned.
- Excellent teamworking and communication skills and a motivation to solve synthetic chemistry and drug development problems.
- Strong communication (verbal and written) and influencing skills.
- 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.
- Good collaboration skills.
- A track record of delivering to deadlines.
- MSc, Chem Eng or PhD in synthetic organic chemistry or chemical development or related subject.
- Previous experience in supporting development for GMP manufacturing from early to late clinical phase.
- Previous experience with managing activities at CMO along with early and late stage/commercial biopharmaceutical drug programs.
- Experience of chemical process development and support to scale up and experience in designing new route of access of molecules.
- Direct experience in Process Validation enabling development study and Process Validation oversight.
- Awareness of a range of analytical technique and knowledgeable with NMR, HPLC and MS for structural determination.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.