Sr. Director, Tech Transfer

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.