Fill & Finish SME
Proclinical is in search for an experienced Fill and Finish SME to assist the company, working on multiple projects and programs in Drug Products.
- Act as a top-level technical or functional expert to be able of working on multiple projects and programs that support one or more projects in the Drug Product/Fill & Finish business unit including feasibility through to detailed design and construction / qualification.
- Drive technical discussions and decisions based on cost, schedule and technical suitability.
- Perform business development activities, including providing technical input when required or consultation.
- Evaluate technical solutions/challenges which may increase in scope and complexity while bringing project specific and general drug product manufacturing experience.
- Propose phase appropriate solutions and recommendations on an ongoing basis during project execution.
- Communicate and tackle project?challenges in advance to allow fast-paced project environment. ?
- Lead the development of deliverable content that meets the needs of the client.
- Provide expertise on Formulation, Filling, Lyophilization, Inspection and Packaging.
- Initiation and lead in the definition of standard set-ups and technical solutions for sterile manufacturing.
- Definition of required templates to get requirements and technical designs aligned.
- Support in trouble shouting in case of severe functional or regulatory issues.
Skills and Requirements
- Bachelors degree is scientific related field
- Experience in the pharmaceutical industry
- Excellent understanding of overall pharmaceutical strategy
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.