Manufacturing Services Technical Transfer Lead (Manager/Senior Manager)
AavantiBio is seeking a highly motivated Technical Transfer Lead to be responsible for overseeing the activities associated with the transfer and implementation of our gene therapy processes at external manufacturing partners. The ideal candidate will be able to apply a strong depth of applied manufacturing sciences and technical project management to deliver all manufacturing preparations to meet quality requirements while coordinating across internal and external stakeholders including Process and Analytical Development, Quality, Regulatory, and CDMO functions. This key role, which reports to the Vice President of Manufacturing, will collaborate with key stakeholders on the east coast and can be remote.
Benefits for this Full Time Position:
Benefits include high-quality health insurance plans including both gold and platinum Blue Cross Blue Shield plans, for which AavantiBio pays a competitive 85% of the health insurance premiums for our employees and their families. In addition to health insurance, we have put in place flexible spending accounts and other benefits for our employees, including dental, vision, short- and long-term disability, group life insurance, AFLAC, and more. To assist our employees with their retirement planning, AavantiBio offers a safe-harbor 401(k) plan with a generous 6% company match.
Responsibilities including but not limited
• Lead technical transfer of drug substance and drug product manufacturing activities.
• Act as the key technical manufacturing contact for the CDMO by attaining an in-depth understanding and knowledge of the manufacturing processes, analytical package, materials, and equipment to be able to quickly assess issues, propose solutions to challenges, and facilitate information exchange.
• Maintain awareness of process development, analytical development, and material supply challenges. Ensure process and project timeline issues are escalated and addressed.
• Generate and/or review key technical transfer documentation including Technical Transfer Plans, Process Flow Diagrams, Manufacturing Process Descriptions, Process Risk Assessments, manufacturing/campaign summary reports, and comparability assessments.
• Provide direct oversight of manufacturing readiness preparations at the CDMO ensuring on-time execution of project plans and technical accuracy of the implemented process.
• Review and/or approve of CDMO manufacturing documentation including manufacturing bill of materials, production master batch records, and executed production record review.
• Serve as Person-in-Plant (PIP) for critical steps during manufacturing campaigns especially for initial batch introduction and scale-up executions.
• Support the evaluation of process change controls and deviation investigations. Provide assessments of product and process impact and contribute to the identification of root cause and determination and development of appropriate action plans.
• Gather and compile process data for manufacturing including process performance data and analytical results. Provide data analysis/trending using appropriate visualization tools to compare performance vs. historical and developmental expectations.
• Contribute to the development of internal policies, procedures, and/or business practices for the management of technical transfer and manufacturing at 3rd parties.
· Performs other related duties as assigned.
Required Education and Experience:
· Bachelor's degree in Chemical Engineering, Biochemistry, Biotechnology, or related discipline with a minimum of 7 years’ experience or advanced degree with 5 years’ experience in biopharmaceutical-based GMP manufacturing science and technology
· Direct experience in technical transfer/scale-up and Gene Therapy manufacturing highly desired.
· Experience in writing and revising protocols, procedures, reports, and other process related documentation as necessary to support process scale-up, transfer, and implementation to cGMP manufacturing operations.
· Experience in with troubleshooting and providing solutions to complex technical and logistical issues.
• Working knowledge of GMP manufacturing, quality standards, and regulatory requirements.
• Excellent oral and written communication skills to build relationships both inside and outside the company.
• Ability to perform well under tight timelines with excellent decision making under pressure.
• Ability to work independently and desire to work in a fast-paced, dynamic start-up environment.
The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of an employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
About the Company - AavantiBio, Inc.
Biotechnology – 30-50 employees
AavantiBio is a clinical-stage biopharmaceutical company committed to developing and commercializing novel gene transfer and gene editing therapies for the treatment of rare and ultra-rare genetic diseases. The company is rapidly building a diverse portfolio of gene transfer and gene editing therapies to target debilitating genetic diseases for which the unmet medical need is high and for which there are typically no approved therapies treating the underlying disease.
Headquartered in Cambridge, MA with an additional location in Gainesville, FL, AavantiBio is looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene transfer therapy.
AavantiBio is committed to nondiscrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.