Job Description

General Summary:

The Senior Manager will manage a team within VCGT Device Analytical Development that is focused on commercial device and combination product development. The team will work closely with the Commercial Process Development team and Contract Manufacturers to develop and transfer methods for use in commercial manufacturing. This role is critical to bringing a transformative cell therapy device to patients at the highest level of safety and quality.

Key Duties and Responsibilities:

• Design, execute and analyze study data in order to develop, transfer, and qualify test methods for commercial processes in support of clinical manufacturing and BLA.
• Lead a team of 2-3 members and coordinate activities with partner analytical groups in the execution of key project activities.
• Enable transfer of assays to CMOs and provide SME to support for assay qualification, author transfer/qualification protocols and reports
• Troubleshoot, optimize, and trend assay and process performance as part of management of activities at third party vendors/CMOs
• Evaluate manufacturing facilities for suitability for GMP manufacturing.
• Demonstrate technological feasibility of the process and characterize material and assembled device products, employing multiple analytical methods (e.g. FTIR, DSC, TGA, viscosity, chromatography [GC, HPLC], visual inspection, material stress/strain characteristics, and mechanical tests for hardness)
• Report on project progress, write analytical development protocols and reports, provide recommendations to management
• Identify, qualify, and manage analytical reagents and standards as per regulatory standards, including impurity identification and PMI assessment.
• Author regulatory submission documents with detailed method descriptions and data analysis.
• Maintain excellent written documentation and reviews (e.g. lab notebook and test forms).
• Ensure the accuracy and integrity of analytical data generated within the team.

Knowledge and Skills:

• Advanced knowledge and hands on experience in at least two of the following methods or areas: FTIR, TGA, DSC, porosity/flux, chromatography [GC, HPLC, UPLC, SEC], structural elucidation [LC-MS, GC-MS], microscopy, spectroscopy, and mechanical material characterization (e.g. hardness, viscosity, stress/strain curves).
• Project and people management experience in relevant area and ability to multi-task to manage competing project goals.
• Familiarity with cGMPs and regulatory guidances related to impurities (e.g. ICH Q2, Q3D, M7) and Medical Devices (ISO 13485, 21 CFR Part 820)
• Expertise in development, validation, and transfer of analytical methods.
• Demonstrated leadership with method qualification and transfer between groups, sites or a CRO/CMO
• Strong skills for collaboration across teams for technical and business development activities
• Experience with regulatory agency submissions and correspondence
• Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team

Education and Experience:

• Required:
  PhD in Materials Science, Analytical Chemistry, Biomedical engineering, Polymer Chemistry or related discipline with 5+ years of relevant pharmaceutical or medical device industry experience in post-graduation assay/analytical development. Or Masters in Materials Science, Analytical Chemistry, Biomedical engineering, Polymer Chemistry or related discipline and 8+ years of relevant experience. Or Bachelors and 10+ years of relevant experience.

Company Information