A leading biopharmaceutical company has an exciting opportunity for a Technology Transfer Project Leader to join its team on a 12 month fixed term contract. You will be responsible for ensuring that all Manufacturing and analytical processes are validated according to Good Manufacturing Practice. You must have previous experience in method development and tech transfer.
Principle responsibilities will include:
- To provide R&D an initial sounding board on projects in development, including process and analytical method robustness, reliability, cost, and duration.
- Responsible for ensuring all product and raw material tests are validated, documented, approved and archived to GMP standards.
- Responsible for carrying out lab-scale trials in support of technology transfer projects or process optimization projects.
- To provide support to the Quality Control Team for production tests from a retest / investigation process and to support testing of analytical methods that still require transfer to their other site
- Responsible for coordinating assigned validation projects from R&D (in Cambridge) through to Production on another site
- To provide training support to Technology Transfer specialists in other sites along with Quality Control and Production staff when required.
- To support production in review of batch records for upscaling and new product introduction.
- To support the completion of regulatory support files and regulatory submissions as required.
- To support Quality, Production and Quality Control departments in root cause investigations as required.
- To ensure that there are suitable procedures and forms to ensure standardisation within Technology Transfer department, R&D and other teams.
Qualifications, Skills and Experience
- Experience in method transfer and validation within regulated environment
- Science degree preferably in Chemistry or Biosciences
- Excellent team-working abilities
- Proven technical leadership
- Good project management
- Sound decision making
- Excellent oral and written communication skills
- Good presentation skills
- Self-disciplined time management
Salary £35k - £45k 12month Fixed Term Contract