Dsp Production Manager

vor 2 Wochen

Basel, Schweiz Axepta SA Vollzeit

My client is a growing international biopharmaceutical company.

Due to this growth my client is looking a DSP Production Manager for their biomanufacturing site based around lake Neuchatel.

RESPONSABILITIES
- Lead and manage all manufacturing operations related to DSP and Solution preparation activities within Drug Substance Manufacturing under cGMP
- Support regulatory inspections and audits as necessary.
- Line manage a group of Associate Managers/Team Lead and theirs respective teams
- Manage, plan, lead and execute batch related activities - including batch release
- Responsible to meet production and quality performance goals.
- Accountable to manage new Process/Product Implementation.
- Own training matrix and prepare and deliver training to new members of the team
- Author, review, approve, maintain life cycle (...etc.) of all required Standard Operating Procedures, Work Instructions, Manufacturing Batch Records, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required
- Own training matrix and prepare and deliver training to new members of the team
- Act as a mentor to more junior team members and lead by example to ensure timely batch execution and release, and proactively propose problem resolution
- Provide support during Health Authorities inspection
- Raise, investigate and close events, deviations and non-conformances
- Contribute positively to a strong culture of business integrity and ethics
- Lead new process technologies implementation

Your profile:

- Biotechnology or pharmaceutical BSc (e.g. Swiss HES) degree preferred or relevant experience from chemical, food, pharmaceutical or biotech industry
- 8-10 years solid hands-on experience of USP/DSP manufacturing
- Must have hands-on experience of equipment commissioning and qualification
- French and English
- Teamwork oriented mindset

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