AavantiBio is seeking a highly motivated Associate Director – Manufacturing Sciences and Technology to be responsible for coordinating activities associated with the transfer and implementation of our gene therapy processes at external manufacturing partners. The ideal candidate will be able to apply 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 individual will report into the Vice President of Manufacturing and will be based at a mutually agreeable location.
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 to:
Serve as a technical representative within functional team supporting external manufacturing and tech transfer of Gene Therapy Drug Substance and Drug Product.
Support the phases of the clinical manufacturing project life cycle including, technology transfer, clinical production campaign, deviation evaluation and investigation, batch disposition, and campaign conclusion and summary.
Act as a 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.
Lead delivery, in conjunction with the CDMOs and process development team, of manufacturing readiness deliverables such as Materials List, Process Transfer Documents, Targets and ranges for process control parameters in the Manufacturing Batch Records, Process Monitoring plans, Etc.
Develop bill of materials for manufacturing identifying suitable sources of raw materials and components for use in GMP manufacturing.
Serves as Person-In-Plant (PIP) overseeing manufacturing operations at CMOs. As needed, be present at CMOs & CDMOs to monitor execution of production and studies, as well as provide technical guidance as needed.
Provide direct oversight of manufacturing readiness preparations at the CDMO ensuring on-time execution of project plans and technical accuracy of the implemented process.
Lead the complex scale-up and atypical process performance investigations in close collaboration with Analytical and Process Development SMEs. Provide assessments of product and process impact and contribute to the identification of root cause and determination and development of appropriate action plans.
Serve as a subject matter expert (SME) for the at scale process to internal and external partners.
Author, review, and/or approve key technical documentation supporting manufacturing and regulatory activities including technical risk assessments, manufacturing protocols, campaign reports, and descriptions of manufacturing process and controls.
Proactively identify and develop solutions to complex challenges faced during manufacturing and scale-up. Present options analysis to CMC leadership team and recommended path forward.
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 8+ years of experience.
PhD in Chemical Engineering, Biochemistry, Biotechnology, or related discipline with minimum of 4 years of relevant experience, or Master’s degree with 5 years relevant experience.
Prior experience and expertise working in industrial process development, GMP manufacturing and/or pilot plant environments for the production of protein-based therapeutics and/or vaccines (experience working on viral gene therapy products is a plus).
Detailed knowledge of GMP manufacturing, quality standards, and regulatory requirements.
Demonstrated technical project management experience to develop project goals, deliverables, timelines, budget management and ongoing prioritization.
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 with troubleshooting and providing solutions to complex technical and logistical issues.
Ability to build relationships both inside and outside the company.
Ability to prepare high quality presentations and speak, present data, and defend approaches in front of audiences, including management or regulatory agencies.
Motivated with the ability to work independently as well as on cross-functional and cross-site teams.
Ability to perform well under tight timelines with excellent decision making under pressure.
Ability 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
Biotechnology – 40-60 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.
EQUAL OPPORTUNITY EMPLOYER
AavantiBio is committed to non-discrimination 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.