Production Line manager for Biologics (m/w/d).

Job ID: 10904

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Discipline
Quality/Production
Type of employment
Festanstellung
Company

Our Client is a biopharma company with state-of-the-art facilities. Operating across international centers specialized in clinical manufacturing and commercial scale production. Our client provides expertise and facilities from cell line development over process development, API production to fill & finish for partners and in-house biological pipeline. The leading one stop shop for biologics from cell line development to drug product.

Responsibilities

General:

Set up and direct all operations within the Production line to create a strong group capable of supplying Biopharmaceutical products compliant with ICH cGMP standards and create a work environment that attracts and develops biotechnological production talent . Supervise/manage a team of individuals and have responsibility for all activities to supporting GMP manufacture of clinical and future commercial supplies from within the new facility

- In detail:

  • Set up the team and facility for commercial-scale DS (through CMOs and in-house products once applicable)

  • Manage all aspects of mammalian production of therapeutic proteins for drug substance and drug product

  • Set up and manage the cGMP cell culture production

  • Compliance of the facility to current requirements of international guidelines

  • Implement systems and processes in Production Department in close collaboration with the Quality Unit to ensure cGMP compliance with special emphasis to EMA and US FDA requirements

  • Coordinate issue identification and corrective action plans and implement such plans to meet GMP requirements, resolve "issues" and maintain business commitments

  • Ensure introduction and implementation of state-of-the-art technologies to facilitate therapeutic biologics production

  • Active participation in process development to ensure possibility to transfer technology to production

  • Monitor the production processes and process quality, and make improvements as needed

  • Performing all duties with respect to current GMP requirements and other pharmaceutical regulations

  • Represents the company during regulatory inspections
Requirements
  • Academic degree in science (biotechnology, biochemisty, process engineering)

  • more than 5 yrs working in the field of GMP production of Biopharmaceuticals

  • Proven track record in the technical development and production of therapeutic proteins including monoclonal antibodies out of mammalian systems

  • Experience in technology transfer and scale-up

  • Strong communication skills

  • Experience with single-use production equipment / Strong leader and capable of developing people

  • Fluent English language
Benefits
  • An opportunity to build and shape an organization according to your ideas

  • Internationally competitive compensation & benefits
Region
Europa