Sr. Director, Tech Transfer

Sr. Director, Tech Transfer Phlow Corp Richmond, VA Job Details 20 hours ago Qualifications Project team coordination Laboratory safety Laboratory instruments Certified Professional In Patient Safety Chemical Engineering Engineering Six Sigma methodology implementation Engineering process optimization Project timeline management GMP Laboratory equipment calibration Team development ICH guidelines Bachelor's degree Doctor of Philosophy Team management Decision making Master of Science Laboratory compliance Mentoring Bachelor's degree in chemical engineering Quality standards in production Chemistry Regulatory submissions Handling small molecules Senior level Cross-functional collaboration Manufacturing company experience Communication skills Process engineering Chemical engineering Bachelor's degree in chemistry Regulatory compliance management Cross-functional communication FDA regulations 10 years

Full Job Description Description:

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.

Requirements:

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.