Sr. Manager/Associate Director - Chemistry

We are looking for an experienced Sr. Manager/Associate Director - Chemistry to join the CMC team at a clinical-stage drug discovery and development discovering organisation where you will have the opportunity to work within a vibrant development environment. This is a permanent role based in either Cambridge (MA) or Oxfordshire (UK).

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Accountable to contribute to all company chemistry activities, such as design of new synthetic routes, processes suitable for scale up manufacture, specifications definitions etc.
• To develop effective working relationships with the organisation's project team members and external Contract Manufacturing Organisations (CMO).
• To define and implement API development and manufacturing strategy to fulfil project requirement.
• Assists in planning and execution of Chemistry activities.
• Assess and manage chemistry process risks arising from scale, equipment or process changes.
• 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.
• To work closely with analysts, formulation scientists, GMP QA, RA and cross-functionally.
• Support CMC sub teams and programs.
• To provide detailed chemistry reports for projects and external briefing documents and publications.
• Facilitate problem-solving, contingency planning, and decision-making.
• Other activities as may be assigned.

Key Skills:

• Good collaboration skills
• A track record of delivering to deadlines.
• Excellent analytical thinking and problem-solving skills.
• Robust communication (verbal and written) and influencing skills.
• Good information management.
• Excellent interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
• Holds highly effective teamworking and communication skills and a motivation to solve synthetic chemistry and drug development problems.

Requirements:

• MSc, Chem Eng or PhD in synthetic organic chemistry or chemical development or related subject.
• Direct experience in Process Validation enabling development study and Process Validation oversight.
• Previous experience of chemical process development and support to scale up and experience in designing new route of access of molecules.
• Previous experience in supporting development for GMP manufacturing from early to late clinical phase.
• Experience with managing activities at CMO along with early and late stage/commercial biopharmaceutical drug programs.
• Awareness of a range of analytical technique and knowledgeable with NMR, HPLC and MS for structural determination.

Apply now:

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.