Tech Transfer Manager

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. Germany
Heidelberg, Baden-Württemberg
Posting date: 19 Mar 2019
QA.TR.22297_1553006171

ProClinical is advertising a vacancy for a Tech Transfer Manager position with a global pharmaceuticals company that focuses on developing ocular therapeutics. The company is seeking an experienced and driven applicant to join their team in Germany. This is an exciting opportunity to work with an innovative and dynamic organisation that addresses the unmet medical needs of countless patients with eye diseases.

Job Responsibilities:

  • Establishing robust, efficient external pharmaceutical supply chains for successful new product launches from Development through to Commercial.
  • Developing strategies to transfer development products to contract manufacturer organisation (CMOs) for each stage of product supply.
  • Selecting suitable CMOs and maintaining relationships to ensure that scope, executing, the reporting of predefined requirements, and tasks all meet project plans.
  • Defining all product specific requirements like validation, stability, packaging, etc., as part of product target profiles and validation master plans.
  • Maintaining established commercial production in respect of trouble shooting, deviations/complaints, changes, and regular quality reviews.
  • Ensuring that external manufacturing meets global quality standards and applicable regulatory requirements.
  • Compiling specific SOPs/documentation, including regulatory documents for submissions as well as reviewing protocols and reports for completeness, cGMP compliance, and acceptability of data.

Skills and Requirements:

  • A Pharmacist or related scientist background.
  • A proven track record of working with several CMOs and the ability to define key selection criteria.
  • At least 5 years of experience in the manufacturing processes, validation, and change control concepts.
  • Experience in the compilation of relevant procedures/protocols/reports and regulatory submissions documents.
  • An excellent understanding of FDA, EU, and ICH cGMP guidelines and industry best practices.
  • Expertise in validation and qualification principles and standards with a demonstrated ability to apply these to GMP operations.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Tanja Ruschenschmidt at + 207 440 0632 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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