Director of Technology Transfer - Genezen

JOB SUMMARY

The Director of Technology Transfer will oversee technology transfer (TT) activities across two sites, ensuring the seamless transition of gene and cell therapy products from early clinical development to commercial manufacturing. This leader will guide cross-functional teams responsible for process transfers, lifecycle management, and GMP compliance in a fast-paced, dynamic environment. The role requires collaboration across manufacturing, quality assurance, regulatory, and other key functions to ensure the successful production of safe and compliant products.

Fishers, Indiana (Early Clinical Manufacturing Site, MSAT and Technology Transfer Activities)

Lexington, MA (Late-Stage and Commercial Manufacturing Site, Technology Transfer, and Process Characterization)

ESSENTIAL JOB FUNCTIONS

• Provide technical leadership for process transfers, including early clinical manufacturing in Fishers and process characterization for late-stage commercial manufacturing in Lexington.
• Build a high-performing team and culture that values communication, action orientation, and a sense of urgency.
• Lead, mentor, and develop a team of Technical Writers, Technology Transfer Scientists.
• Act as a key member of the site leadership team, driving collaboration within the site and across the sites.
• Partner with stakeholders across QA, Process Development, MSAT, Manufacturing and other departments to ensure successful process transfers and commercialization.
• Lead technical transfer activities between sites, clients and internal teams, ensuring clarity in communication and alignment across projects.
• Provide oversight for process characterization, process validation, and lifecycle management.
• Own process transfer activities, including design, construction, qualification, and validation of multi-product gene and cell therapy products.
• Drive continuous improvements, process optimization, and efficiency improvements in alignment with regulatory and compliance requirements (cGMP).
• Establish and implement systems to monitor and optimize process performance.
• Lead investigations and support root cause analysis for process transfers and technical challenges at Fishers site and support for Lexington site.
• Ensure the overall success of assigned projects by identifying and tracking progress against key milestones.
• Work with clients to identify and mitigate risks to manufacturing in the early phases of new product development.
• Be an active and visible change agent, promoting a flexible and open mindset that embraces new opportunities and drives for excellence.
• Establish strategic goals and objectives that align with TT responsibilities, organizational performance, and team development.
• Continuously monitor, analyze, and optimize ongoing production and cleaning processes, ensuring validation and compliance.
• Assess manufacturing requirements and capabilities prior to the transfer of new processes into manufacturing facilities, generating facility fit assessment and high-level gap assessments.
• Accountable for generating, reviewing, and delivering comprehensive documentation supporting technology transfer, including manufacturing records, process descriptions, and detailed gap assessments.
• Lead study teams and investigations during transfers, ensuring thorough analysis and effective root cause determination.
• Stay current with industry trends and technological advancements to drive innovation in process development.
• Review and implement continuous improvement initiatives to enhance process efficiency, yield, and product quality.
• Build a knowledge base and lessons learned database to identify and implement continuous improvement activities.
• Support regulatory filings and justifications as a member of the technical regulatory response team.
• Ensure a safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies for all direct reports.
• Work closely with clients to assess manufacturing requirements and capabilities, delivering comprehensive technical transfer reports.
• Train employees on written procedures, including batch records and operating procedures, to ensure consistent quality and compliance.

KNOWLEDGE, SKILLS AND EXPERIENCE

• B.S. degree in Biology, Biochemistry, Molecular Biology or similar field
• 3+ years of relevant industry experience in R&D, product development or operations
• Excellent computer, verbal and written communication skills
• Knowledge in process validation, equipment qualification and aseptic process equipment requirements
• Ability to interpret and analyze data, define problems, establish facts, draw valid conclusions and make decisions
• Ability to maintain multiple projects and timelines
• Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills
• Experience with document control systems: drafting and maintaining revision control on procedures
• ERP and LIMS experience
• Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential 

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, and ability to adjust focus. 
• In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.