Senior Manager - Analytical Method Transfer.

For our client, an international pharmaceutical company, we are looking for a: 

Senior Manager - Analytical Method Transfer

Location: Eysins

Contract: Permanent

Your main goals:

• Coordinate the physicochemical assays transfers, establishment and project monitoring from beginning to end between the transferring and the receiving laboratories of DS manufacturing sites

• Guide cross-functional teams within different geographies and companies and foster collaboration to achieve results on time

• CMC member of the Product Team(s) responsible for the technical aspects of compliant analytical method transfers during late-development or commercial phase

Your Responsibilities: 

• Oversee and guide analytical method transfer activities: team composition definition, transfer of documentation, knowledge transfer from donor site to receiving site including analyst training, feasibility experiments, risk/gap assessment, analytical method transfer protocol, experimental execution according to method transfer approach, evaluation of results, reporting, troubleshooting

• Establish product-specific analytical tech transfer strategy and plans with tech transfer team

• Assist in definition of site resource needs and get management approval via global technology transfer manager for the analytical transfer costs (e.g. FTEs, reagents costs, investments and external costs), strategies and timelines

• Track the progress and openly communicate updates, risks and mitigation strategies, build and sustain transparency with stakeholders and management

• Ensure timely availability of technical documentation pertaining to analytical transfers. Review analytical methods transfer documents as well as key project documents and coordinate technical input in relevant registration documents for accuracy and completeness as appropriate

• Ensure that company guidelines, Health Authority and GMP guidelines are met

• Travel (15-20%) is expected

• Initiate and own change control for method transfers. Assist CAPA and root cause analysis / investigations as a technical subject matter expert

• Align on dossier updates with CMC Regulatory Affairs

Your profile:

Education:

• Preferably PhD - otherwise Master - in biochemistry, biotechnology, pharmacy, biophysics or similar

Languages

• Fluency in English. Fluency/strong proficiency in Spanish would be a plus. French would be an asset.

Work experience

• Minimum 8 years driving analytical tech transfer of in-house and compendial methods for commercial products in highly regulated markets

• Strong background in analytical science for biologics with a focus on physicochemical analytics

• Good understanding of cGMP requirements, audits and HA interactions

• Be a conductor of activities and must have the skills to indirectly influence the project teams, manage international interactions, and be able to interact with technicians understanding their needs and anticipating issues in the process. The person is an individual contributor; but also, must manage a wide project team comprehensive of various internal and external stakeholders in various countries (mainly Switzerland, Italy, Spain and/or Argentina)

• Skilled problem solver

• Good interpersonal, networking and teamwork skills

• Excellent organizational and time management skills

• Proactive work style