Consultant profile

GMP assessment and technology transfer subject matter experts (SME) The expert consultant will support our technical staff with tasks associated with the GMP assessment and technology transfer for OSDs and sterile drug products and associated active pharmaceutical ingredients.

Assignments will include:

• GAP assessments to support the selection of manufacturers to receive technology transfer.
• Review of technology transfer documents such as product development reports, product characterization, batch manufacturing and/or packaging records to provide the technical analysis for the overall process.
• Based on analysis, identify gaps in capabilities/equipment and processes needed to support new product introductions and recommend solutions to close these gaps.
• Technical support during development and scale-up activities and identify opportunities for process optimization.
• The evaluation and selection of new equipment in support of fill/finish production operations in collaboration with manufacturers and internal stakeholders.
• Participation in multidisciplinary project teams through the complete product transfer process to support ongoing client projects on-time.
• Develop Investigations and Corrective Actions analysis and support implementation.
  Candidate Requirements:
• B.S in Pharmaceutical Sciences (or equivalent), M.S in Pharmaceutical Sciences (or equivalent), or PhD in Pharmaceutical Sciences (or equivalent).
• Minimum 10 years of operational experience.
• Knowledge of technology transfer and GMP pharmaceutical processes is required, preferably with experience in aseptic processes.
• Experience with API manufacturing.
• Past experience with reproductive health medicines is desirable.

Additional Skills:

• Fluent in English
• Good communication skills
• Team player with a hands-on mentality.