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Head of Laboratory - Primary Packaging and Process Development
Functional area:Research & Development
As Head of Laboratory Primary Packaging Development you lead primary packaging development activities for sterile, parenteral dosage forms presented in e.g. vials, syringes, carpules.
With your knowledge in evaluation of container closure systems (e.g. functional testing, container closure integrity testing, compatibility testing) and supplier coordination activities, you are able to represent the primary packaging development within the respective R&D teams.
The position is limited for 2 years.
Tasks & responsibilities
- Acting as a Head of Laboratory means leading a laboratory dedicated to develop primary packaging systems for all parenteral development projects including technical transfer to pilot plant and first manufacturer
- In your new role, you drive parenteral primary packaging development for NBE and NCE projects to support drug product development including submission
- You represent primary packaging development in international R&D Teams and lead multidisciplinary project teams regarding drug product development
- As Head of Laboratory you evaluate new primary packaging technologies on a scientific basis.
- You prepare the documentation for submission with respect to primary packaging (IND/CTA, MAA/BLA).
- Degree in pharmaceutical sciences, engineering sciences, physics or related disciplines, ideally Ph.D.
- Several years of experience in primary packaging design and development, either in pharmaceutical, medical device or biotech industry is required
- Knowledge in the coordination of activities at third party manufacturer and vendors
- Broad expertise around regulatory requirements for primary packaging materials and parenteral combination products is preferred (21 CFR parts 4 & 820, ISO, ASTM, FDA and WHO guidance’s)
- Hands-on experience with different analytical test procedures like container closure integrity testing, functional testing
- Statistical know-how and experience is preferred e.g. tolerance analysis, gauge R&R and design of experiments (DOE) methodologies
- Good compatibility of work and private life
- Good development opportunities with in-house education and various training options
- Competitive salary plus bonus payments
ContactFor further information please contact Recruiting Services:
Tel: +49 (0) 7351 - 54 17 50 92