Head of Process Development, Gene Therapy

Reporting to the Technical Head of the Gene Therapy Franchise, the Head of Process Development (PD) is responsible for supporting internal platform development activities, process/product development initiation, implementation, and execution for Resilience's gene therapy clients in a development environment.

Role & Responsibilities

• Plan and direct the long term/strategic and short-term/tactical activities of the PD team to meet or exceed project and customer deadlines.

• Maintain a high level of technical acumen in the field of viral vector process development to drive innovative and disruptive technologies in the franchise.

• Ensure a successful technical transfer of projects from Process and Analytical Development (PAD) to the GMP manufacturing operations group by partnering with manufacturing leadership to:

  • Provide accurate and timely project transfer readiness information to operations planners/schedulers

  • Communicate the associated transfer dates and materials required

• Build and maintain two-way communication channels with the Business Development teams to share and understand market pricing and acceptable industry practices affecting projects or potential projects for the company.

• Provide strategic planning and technical leadership on projects being performed at the Waltham PAD facility.

• Create and deliver technically sound scientific presentations to internal and external stakeholders, partners, and potential clients.

• Participate in proposal writing and reviews

• Serve as PI on Product Development Teams (PDT) for integration of internal and subcontracted activities

• Develop in-depth knowledge of proposed projects and the associated technical work required by thoroughly reading and developing an understanding of contract proposals as they are being developed/awarded and the impact of those on the PD team.

• Review all PD contractual documents prior to submission to the client. This includes Process Development Plans, all PDPRs and reports, interim reports, and final reports to ensure document quality and consistency.

• Review all manuscripts/posters/presentations prior to submission from all work related to PD at Waltham facility

• Develop, implement, direct, and ensure timely completion of all PD activities for all contracted projects

• Develop expert knowledge of every PD project and their parameters to answer questions readily and accurately from internal/external stakeholders, including:

  • Maintain knowledge of the objectives and scope of each project

  • Providing routine and ad-hoc updates (accurate to within a couple of days)

  • Assess and report on potential areas of success or concern associated with each of the projects (accurate to within a couple of days)

  • Function as an expert resource for internal staff on PD projects

• Assume a leadership role in formulating new initiatives in PAD.

• Develop strong leaders and maintain a culture of collaboration, accountability, success, growth and development and retention of high performing staff.

• Build strong, collegial, working relationships with colleagues across the company to accomplish company goals.

• Adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role, like all employees.

Experience, Education & Qualifications

• MS, PhD or equivalent degree in biology, chemistry, engineering, or related field, (doctoral degree preferred).

• Minimum of 10 years of experience in the biopharmaceutical industry, specifically experience with a wide variety of expression and purification platforms to produce AAV and LVV viral vectors

• 4+ years of experience in a leadership role, with demonstrated success in building highly effective teams.

• Demonstrated professionalism with excellent communication and organizational skills.

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