As the Sr. Director of Tech Transfer, you will play a pivotal role in ensuring the seamless transition of pharmaceutical products and processes from R&D to manufacturing or between manufacturing sites. This role requires strong collaboration with Manufacturing Science & Technology (MS&T), Operations, Regulatory, Quality and other cross-functional teams to drive efficient and compliant technology transfers. Additionally, you will contribute to strategic decision-making regarding product manufacturing priorities, leveraging your expertise in chemistry and the pharmaceutical industry.
Tech Transfer Leadership:
- Lead the planning and execution of technology transfer projects, ensuring alignment with operational and regulatory requirements.
- Develop and manage project plans, timelines, and risk assessments to ensure successful outcomes.
Collaboration with Cross-Functional Teams:
- Partner with MS&T, Operations, Quality, and R&D to facilitate seamless communication and decision-making throughout the tech transfer process.
- Act as a technical point of contact to address challenges and align on objectives.
Process Evaluation and Optimization:
- Evaluate the scalability and manufacturability of processes, identifying opportunities for enhancement.
- Apply QbD principles for determining Critical Process Parameters (CPPs), Proven Acceptable Ranges (PARs) and other parameters to determine Design Space (DS) to drive operational efficiencies.
- Drive improvements to ensure processes meet Good Manufacturing Practices (GMP) and operational efficiencies.
Strategic Input on Product Manufacturing:
- Provide technical and operational guidance to help prioritize which products to manufacture.
- Collaborate on decisions considering technical feasibility, capacity, and business needs.
Regulatory and Quality Compliance:
- Ensure all activities are conducted in compliance with applicable regulatory guidelines and company quality standards.
- Support the preparation and review of regulatory filings related to tech transfer.
Team Leadership and Development:
- Mentor and guide team members, fostering a collaborative and high-performance culture.
- Provide opportunities for professional development to build team expertise.
Experience & Qualifications:
- Bachelor’s degree in Chemistry, Chemical Engineering, or related field; advanced degree (MS or PhD) strongly preferred.
- Minimum of 10 years of experience in the pharmaceutical industry, with expertise in tech transfer, MS&T, or manufacturing operations.
- In-depth knowledge of chemistry and its application in pharmaceutical manufacturing.
- Proven ability to lead complex projects in a GMP environment.
- Strong understanding of regulatory requirements (e.g., FDA, EMA, ICH).
- Excellent written and verbal communication skills
Preferred Qualifications:
- Experience with both small molecule and biologics processes.
- Familiarity with Lean or Six Sigma methodologies.
Physical Requirements
- Ability to work in a laboratory environment, including standing for extended periods.
- Capability to use and handle laboratory equipment
- Manual dexterity for fine manipulations, such as calibrating instruments or preparing samples.
- Frequent walking and movement between workstations, offices, and laboratory spaces.
- Occasional bending, crouching, or reaching to access equipment or supplies.
- Sharp vision for detailed tasks such as reading data, analyzing test results, and inspecting equipment.
- Ability to distinguish color changes in tests and monitor digital displays on instruments.
- Clear hearing for effective communication and responding to audible alarms from laboratory equipment.
- Ability to work in environments with controlled exposure to chemicals, solvents, or other laboratory materials, adhering to safety protocols (e.g., wearing PPE).
- Tolerance for wearing personal protective equipment (PPE), including gloves, safety glasses, lab coats, and occasionally respirators.
