Advisor - Technical Lead Scientist - Advanced Therapies Manufacturing

Position Description

The TS/MS Technical Lead will provide technical leadership and oversight to clinical and commercialization activities of gene therapy products at the Lebanon Advanced Therapies (LP2) site. The scope of the role includes all clinical trial and commercialization gene therapy products such as technology transfer, validation, drug substances and products production, inspection, submission and filing.

• Understand the scientific principles required for manufacturing intermediates, bulk drug substances and drug products for gene therapy products commercialization.
• Provide product and process technical knowledge to identify appropriate manufacturing approaches for processing of new products.
• Support identification and development of new manufacturing technologies and processes to support commercialization.
• Lead risk management activities as it pertains to new products (FMEA).
• Own Tech Transfer strategy for the manufacturing site.
• Ensure that an accurate instruction set (eBRs and procedures) and PFD describe the process and control strategy for new products.
• Drive technical excellence through meaningful specifications, including approval of local specifications and influencing global specifications.
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: tech transfer risk assessments / plans / reports, change controls, regulatory submissions, deviation investigations, stability strategies, validations, procedures, specifications, PFDs, etc.
• Manufacturing site representative for new product regulatory submissions, including authoring and/or reviewing relevant submission document sections.
• Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in LP2.
• Serve as technical interface with development.
• Communicate effectively with process team members, development colleagues, tech transfer team members, and other parties.
• Identify opportunities for best practices and implement improvements to manufacturing technology.
• Own and prepare Annual Product Reviews, etc.

Basic Requirements

• B.S. in Biotechnology, Biochemistry or related quantitative field
• 3+ years of experience in pharmaceutical/biotech manufacturing industry
• 1+ year of experience with new product submission and filing

Additional Preferences

• Experience with product commercialization
• Demonstrated experience managing and collaborating with CMOs
• Demonstrated technical capability with high productivity
• Proven track record of curiosity with learning agility
• Self-starter with high initiative and data-driven approach to problem-solving
• Demonstrated strong interpersonal skills
• Demonstrated strong verbal and written communication skills
• Demonstrated adaptability and flexibility to working in different environments, teams etc.
• Demonstrated ability to participate in and facilitate decision-making