Avirmax, Inc.
Director/Sr. Director of Vector Manufacturing
Avirmax CMC, Inc.
based in San Francisco Bay Area, is dedicated to innovating, developing and manufacturing adeno-associated virus (AAV) vector–mediated biotherapeutics using its proprietary protein therapeutics and GMP VSaf TM Sf9-AAV technologies. The company has successfully produced and delivered products for toxicology studies as well as GMP compliant AAV drug products for clinical trials. We are looking for a highly motivated, energetic, collaborative and experienced individual to lead the company’s AAV vector manufacturing operation. This position provides an exciting opportunity for career development and expanding expertise in cGMP AAV manufacturing. Overview
Job Type: Full-time Responsibilities
GMP Manufacturing Oversight to lead process development, GMP compliant manufacturing, change control, troubleshooting of manufacturing issues, investigations and resolution of deviations as AAV products transition from toxicology to clinical material productions. Drive site readiness, operational excellence, and efficient execution of clinical and commercial manufacturing goals. Manage, oversee, and develop activities/processes in support of developmental and GMP manufacturing; review/approve manufacturing batch production records, protocols, development reports, specifications and deviations. Deliver quality AAV products to internal and external customers for non-clinical and clinical investigations. Regularly collate manufacturing data and develop metrics, control charts and reports to improve manufacturing processes. Prepare protocols, reports, standard operating procedures, batch production records, change controls, and other related documents. Review executed batch production records. Ensure the security of the supply chain for raw materials and intermediates. Prepare technical risk assessments to ensure normal manufacturing operations. Team Leadership and Collaboration
Lead, develop, and manage manufacturing teams, fostering a culture of quality, safety, and operational excellence. Lead efforts for process development, scale-up, and continuous improvement to optimize yields and product quality. Work with Quality Assurance (QA), Quality Control (QC), Research, Development, Regulatory and Clinical teams to ensure seamless product development and manufacturing. Collaborate with cross-functional teams including internal and external partners to align manufacturing schedules and forecasts with client needs; prepare requests for proposals, statements of work, source raw materials, and identify activities that may affect supply, communicating with management as needed. Enforce contractual commitments with legal/contractual partners. Manage budgets and resources; oversee operational budgets and control manufacturing costs. Quality Assurance, Regulatory & Compliance
Ensure strict adherence to GMP regulations and global regulatory requirements. Collaborate with Quality teams to meet GMP standards and complete agreed-upon quality improvement deliverables. Work with Regulatory Affairs to draft/review CMC sections of regulatory submissions and support information requests from regulatory agencies. Qualifications
Ph.D., MSc in Biochemical Engineering or relevant scientific field. At least 10 years of experience in biopharmaceutical development and cGMP manufacturing. Applicants must be currently authorized to work in the United States on a full-time basis. 10+ years in biopharmaceutical manufacturing operations, particularly with AAV production systems. Deep understanding and technical expertise in viral vector manufacturing processes and analytical methods. Extensive knowledge of GMP principles in a cell and gene therapy environment (QA, QC, validation, supply chain, manufacturing). Experience with quality management systems, change control, deviations, and CAPAs. Strong understanding of regulatory requirements and experience interacting with regulatory agencies. Excellent written and oral communication skills to collaborate with cross-functional teams, clients, vendors and stakeholders. Proven experience in leading teams, developing capabilities, and managing complex projects. Experience with single-use bioreactors (SUB) and closed cell culture systems, and purification of AAV products at various scales. Ability to implement new technologies; strong organizational skills; ability to interact with senior management for resources and budget planning. Ability to establish and maintain a network of preferred vendors and to prepare business agreements, service terms and contract pricing. Benefits
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including awards and stock option plans. Avirmax offers comprehensive benefits including medical, dental, vision, 401(k), paid vacation and holidays. Avirmax is an equal opportunity employer.
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Avirmax CMC, Inc.
based in San Francisco Bay Area, is dedicated to innovating, developing and manufacturing adeno-associated virus (AAV) vector–mediated biotherapeutics using its proprietary protein therapeutics and GMP VSaf TM Sf9-AAV technologies. The company has successfully produced and delivered products for toxicology studies as well as GMP compliant AAV drug products for clinical trials. We are looking for a highly motivated, energetic, collaborative and experienced individual to lead the company’s AAV vector manufacturing operation. This position provides an exciting opportunity for career development and expanding expertise in cGMP AAV manufacturing. Overview
Job Type: Full-time Responsibilities
GMP Manufacturing Oversight to lead process development, GMP compliant manufacturing, change control, troubleshooting of manufacturing issues, investigations and resolution of deviations as AAV products transition from toxicology to clinical material productions. Drive site readiness, operational excellence, and efficient execution of clinical and commercial manufacturing goals. Manage, oversee, and develop activities/processes in support of developmental and GMP manufacturing; review/approve manufacturing batch production records, protocols, development reports, specifications and deviations. Deliver quality AAV products to internal and external customers for non-clinical and clinical investigations. Regularly collate manufacturing data and develop metrics, control charts and reports to improve manufacturing processes. Prepare protocols, reports, standard operating procedures, batch production records, change controls, and other related documents. Review executed batch production records. Ensure the security of the supply chain for raw materials and intermediates. Prepare technical risk assessments to ensure normal manufacturing operations. Team Leadership and Collaboration
Lead, develop, and manage manufacturing teams, fostering a culture of quality, safety, and operational excellence. Lead efforts for process development, scale-up, and continuous improvement to optimize yields and product quality. Work with Quality Assurance (QA), Quality Control (QC), Research, Development, Regulatory and Clinical teams to ensure seamless product development and manufacturing. Collaborate with cross-functional teams including internal and external partners to align manufacturing schedules and forecasts with client needs; prepare requests for proposals, statements of work, source raw materials, and identify activities that may affect supply, communicating with management as needed. Enforce contractual commitments with legal/contractual partners. Manage budgets and resources; oversee operational budgets and control manufacturing costs. Quality Assurance, Regulatory & Compliance
Ensure strict adherence to GMP regulations and global regulatory requirements. Collaborate with Quality teams to meet GMP standards and complete agreed-upon quality improvement deliverables. Work with Regulatory Affairs to draft/review CMC sections of regulatory submissions and support information requests from regulatory agencies. Qualifications
Ph.D., MSc in Biochemical Engineering or relevant scientific field. At least 10 years of experience in biopharmaceutical development and cGMP manufacturing. Applicants must be currently authorized to work in the United States on a full-time basis. 10+ years in biopharmaceutical manufacturing operations, particularly with AAV production systems. Deep understanding and technical expertise in viral vector manufacturing processes and analytical methods. Extensive knowledge of GMP principles in a cell and gene therapy environment (QA, QC, validation, supply chain, manufacturing). Experience with quality management systems, change control, deviations, and CAPAs. Strong understanding of regulatory requirements and experience interacting with regulatory agencies. Excellent written and oral communication skills to collaborate with cross-functional teams, clients, vendors and stakeholders. Proven experience in leading teams, developing capabilities, and managing complex projects. Experience with single-use bioreactors (SUB) and closed cell culture systems, and purification of AAV products at various scales. Ability to implement new technologies; strong organizational skills; ability to interact with senior management for resources and budget planning. Ability to establish and maintain a network of preferred vendors and to prepare business agreements, service terms and contract pricing. Benefits
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including awards and stock option plans. Avirmax offers comprehensive benefits including medical, dental, vision, 401(k), paid vacation and holidays. Avirmax is an equal opportunity employer.
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