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EPM are currently partnered with a fast-growing international Biopharmaceutical company that is expanding rapidly in the German market. We are supporting with a Greenfield Project for the company is on the search for a results driven, dedicated candidate to Lead their Downstream Processing team in North Rhein-Westphalia and be part of the site leadership team.
We are searching for a new head of the Manufacturing Science and Technology Department (MSAT). The position will cover areas such as; Technology Transfer, Process (PPQ, CPV), Technical Operations.
KEY ACCOUNTIBILITIES:
- Key member of the Manufacturing leadership team. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
- Liaison with internal and external stakeholders including but not limited to - Drug Substance Process, Analytical, and Formulation Development, Drug Product Development, QA, QC, Regulatory Affairs, CMC, and PM to develop, manufacture, and commercialize protein biopharmaceuticals.
- To build & develop the MSAT function within the organisation.
- Design, and Constriction of the new MSAT laboratory on site.
- Serving as biologics drug substance (inclusive of upstream cell culture and downstream purification) process subject matter expert.
- Providing technical oversight to teams, and coaching to associate staff.
REQUIREMENTS:
- 10+ years of collective industry experience in mammalian cell culture or recovery process development, scale up, process characterization, process , and commercial manufacturing.
- Technology transfer to commercial facility and trouble shooting skills are essential for this position.
- Required specialized skills include a deep conceptual understanding of cell culture and separation principles and a thorough knowledge of cell culture and separation techniques, analytical assays, small and large scale processing equipment, and .
- Demonstrated success in scientific and technical proficiency, bioprocess implementation, operation, and team work are critical for this position.
- Excellent written and oral presentation skill, detail-oriented organizational skill, clear understanding of process control strategy and data management are also required for this position.
EDUCATION
- Ph.D. or M.S. in Biochemistry or Biochemical/Chemical or related field
OTHER SKILLS, ABILITIES & EXPERIENCE:
- Excellent management, leadership and interpersonal skills
- Strong written and oral communication skills
- Broad expertise in molecular biology, cell biology and biochemistry
- Fluent German language skills - advantageous
For further information please reach out directly to Isabel Kennedy of EPM Scientific GmbH.
Associate Director - MSAT (M/F/D)
- Location Dรผsseldorf
- Job type Permanent
- Salary Negotiable
- Discipline Bioengineering & Medical Engineering
- Reference PR/295974_1618821380
We are searching for a new head of the Manufacturing Science and Technology Department (MSAT). The position will cover areas such as; Technology Transfer, Process (PPQ, CPV), Technical Operations.
KEY ACCOUNTIBILITIES:
- Key member of the Manufacturing leadership team. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
- Liaison with internal and external stakeholders including but not limited to - Drug Substance Process, Analytical, and Formulation Development, Drug Product Development, QA, QC, Regulatory Affairs, CMC, and PM to develop, manufacture, and commercialize protein biopharmaceuticals.
- To build & develop the MSAT function within the organisation.
- Design, and Constriction of the new MSAT laboratory on site.
- Serving as biologics drug substance (inclusive of upstream cell culture and downstream purification) process subject matter expert.
- Providing technical oversight to teams, and coaching to associate staff.
REQUIREMENTS:
- 10+ years of collective industry experience in mammalian cell culture or recovery process development, scale up, process characterization, process , and commercial manufacturing.
- Technology transfer to commercial facility and trouble shooting skills are essential for this position.
- Required specialized skills include a deep conceptual understanding of cell culture and separation principles and a thorough knowledge of cell culture and separation techniques, analytical assays, small and large scale processing equipment, and .
- Demonstrated success in scientific and technical proficiency, bioprocess implementation, operation, and team work are critical for this position.
- Excellent written and oral presentation skill, detail-oriented organizational skill, clear understanding of process control strategy and data management are also required for this position.
EDUCATION
- Ph.D. or M.S. in Biochemistry or Biochemical/Chemical or related field
OTHER SKILLS, ABILITIES & EXPERIENCE:
- Excellent management, leadership and interpersonal skills
- Strong written and oral communication skills
- Broad expertise in molecular biology, cell biology and biochemistry
- Fluent German language skills - advantageous
For further information please reach out directly to Isabel Kennedy of EPM Scientific GmbH.