VP, Technical Operations
4 weeks ago
Antheia, Inc. is seeking a highly experienced and skilled Vice President of Technical Operations to lead our scale-up and manufacturing efforts. As a key member of our leadership team, you will be responsible for managing the scale-up and tech transfer of our products to manufacturing partners, working closely with our R&D functions to develop product/process development plans and timelines.
Key Responsibilities:
- Scale-Up and Tech Transfer: Own the tech transfer and scale-up of Antheia processes to commercial scale, including working with the R&D team upstream to design manufacturability into the process.
- Manufacturing Infrastructure Development: Oversee the implementation of U.S. manufacturing infrastructure development and implementation, ensuring compliance with regulatory standards.
- Manufacturing Site Selection: Drive the manufacturing site selection process by maintaining a stable network of capable partners.
- Manufacturing Operations: Manage all internal responsibilities for manufacturing, manufacturing sciences and technology (MSAT), engineering, and oversee the development of future internal pilot scale manufacturing.
- Process Development: Partner with leadership on cross-functional teams to deliver processes and controls that are timely and compliant.
- Regulatory Compliance: Ensure appropriate protocols to support tech transfer including process development, QA/QC, and regulatory.
- Process Equipment Gap Assessments: Assist in process equipment gap assessments and capital project management necessary for manufacturing tech transfer.
- Manufacturing Engineering: Manage manufacturing engineering activities to ensure quality, cost, and customer service goals are met.
- Organizational Development: Build organizational capacity necessary to achieve functional objectives, including recruiting and developing strong scientific and technical talent.
- Process Improvement: Initiate programs to identify improvements for process reliability, manufacturing yield, product quality, efficiency, and customer service.
- Quality Events: Coordinate investigation of quality events with QA and R&D and oversee completion of necessary corrective actions.
- Business Development: Provide support and guidance to the leadership team and reviews business development opportunities.
- Strategic Communication: Regularly communicate strategic and technical information that may affect major business segments.
- Presentations: Organize and present plans in a compelling manner to gain acceptance from target audience.
- Safety Culture: Actively promote safety culture and awareness, demonstrating good safety practices.
Requirements:
- Advanced Degree: Advanced degree or PhD in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or related field.
- Experience: Minimum of 15 years' experience in biopharmaceutical/pharmaceutical manufacturing environment, with a minimum of 5 years' senior management experience.
- Product Development: Experience in early and late-stage product development, ideally having successfully brought a product(s) to market.
- Technical Leadership: Experience leading technical groups to establish and achieve business objectives.
- CMO Environment: Experience working in a CMO environment for manufacturing bio-derived products.
- Technology Transfer: Experience managing technology transfer projects.
- Project Management: Strong project management skills and experience, including process and equipment design, installation, or major modification.
- Organizational and Communication Skills: Strong organizational and communication skills.
Compensation: Full-time base salary range of $240,000 - $285,000, plus an annual bonus potential and equity opportunities.
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