Pharmaceutical Development Formulation

☞ gloor & lang Pharma and Biotech Recruiting

View: 133

Update day: 01-04-2024

Location: Basel Basel-Stadt BS

Category: Health / Medical Care

Industry: Staffing Recruiting

Position: Associate

Job type: Full-time

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Job content

Basel, perm role, Project Management

Our customer is Pharma Player in greater Basel area. R&D need support of an experienced Pharmaceutical Development Manager for oral solid dosage forms. As Pharmaceutical Development Project Manager, you will lead the technical development of several drug product formulations (oral, but also other type of dosage forms) from early stage up to commercialization, including the scale up and process validation at commercial scale (end-to-end product development).

You will lead knowledge transfer from Pharmaceutical Development to Technical Operations, and support the implementation of the manufacturing processes at CMOs and external partners.

Your tasks:
  • Be the pharmaceutical development project representative, and CMC sub-team leader from early formulation development until scale-up and process validation at commercial scale
  • Lead, conduct and manage the in-house formulation and manufacturing process development activities including the direct work with laboratory employees
  • Lead the external formulation and process development work conducted at contract development and contract manufacturing organizations (CDMOs)
  • Manage the manufacture of clinical trial materials (CTM) produced either in-house at the GMP Pilot Plant or at external CDMOs
  • Prepare the GMP documentation required for CTM manufacture, scale-up and process validation batches (e.g. manufacturing batch records)
  • Compile final formulation & process development reports, and actively contribute to writing CMC sections for regulatory filings (e.g. for IMPDs and Module 2/3 of dossiers)
  • Ensure that internal & external product development work is conducted with high quality (e.g. by applying Quality by Design principles) and completed in time and budget
## Your profile:
  • Pharmacist or equivalent with a Master in Sciences, and vast experience in formulation development, preferably with a PhD in pharmaceutical technology
  • Minimum of three (3) years of relevant working experience at the pharmaceutical industry
  • Sound expertise (scientific and technical) in the development of oral solid dosage forms is mandatory; ideally modified release formulations for intestinal targeting
  • Experience in the development of other dosage forms (e.g. enemas, suppositories) is a plus
  • Profound knowledge of GMP, pharmaceutical development and production processes, based on current guidelines (e.g. ICH Q8 (R2) - ICH Q12)
  • Ability to negotiate, plan, and coordinate technical development and manufacturing activities
You are used to utilize a variety of problem solving methods as well as to interface at a senior level with third parties and development partners. You have excellent organisational skills, are able to work independently and work as part of project teams. You are a result driven and hands-on person with passion for drug product development work. We look for a reliable team-player with excellent interpersonal and communication skills

Interested? We are looking forward to get in touch with you.
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Deadline: 16-05-2024

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