Pharmaceutical Operator, Pharmaceutical Manufacturing

We are excited to announce the job opening for an Associate Director (m/f/d) Analytical Transfer Lead to lead and execute analytical transfer activities on Monoclonal Antibodies from R&D to an internal Manufacturing site or to a contract manufacturing organization (CMO).

This position should be ideally located in Boxmeer (the Netherlands) or Unterschleißheim (Germany). The position will require up to 25% international travel.

Your

Key Responsibilities

Lead and execute analytical transfer projects (setting up and execution of transfer plans, resource needs, and timeline adherences) for both drug substance and drug products

Organize analytical activities in a pharmaceutical GMP and Quality Control (QC) environment

Coordinate & mentor ATS (Analytical tech solutions) colleagues remotely to ensure governance of several Monoclonal Antibody projects

Collaborate with R&D, Quality, Regulatory Affairs, external suppliers and division site responsible teams in transfer activities

Supports strategic transfer initiatives like standardizing transfer processes and develop appropriate documentation templates

Build communication and trust with internal and external partners as well as stakeholders

Your Profile

Master, Bachelor, Engineer degree and long year experience in a Pharmaceutical/Chemical/Analytical Science required

At least 8 years’ experience in the research and development, manufacturing and testing of active pharmaceutical ingredients (APIs) or drug products required

Experience in analytical transfer activities and broad understanding of analytical platforms like pharmaceutical analyses (chromatography and physicochemical testing, immunosorbent assays) is an advantage

End to end understanding of pharmaceutical business relationships and the ability to work in cross-functional teams, being able to create a target focused approach

Solid experience working in international project teams

Ability to work independently and make decisions within guidelines and policies that impact own priorities to meet deadlines

Proficient in scientific/technical writing and current computer usage

Required Skills

Adaptability

Adaptability

Aseptic Processing

Assay

Biochemical Analysis

Biochemical Assays

Cell-Based Assays

Chemometrics

Chromatography

Column Chromatography

Cross-Cultural Awareness

Cross-Functional Collaboration

Customer-Focused

Driving Continuous Improvement

Freeze Drying

GMP Compliance

Immunoassays

Immunoprecipitation

Lean Six Sigma Process Improvement

Manufacturing Quality Control

Monoclonal Antibodies

Pharmaceutical Microbiology

Process Improvements

Regulatory Compliance

Risk Management

Requisition : R402432

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