Sr. Manager Process Transfer, Manufacturing Sciences (Gene Therapy)

Job Description

About This Role

Biogen is accelerating its capacity within gene therapy operations with the focused goal that one day we will help transform the way we treat neurological diseases. This Manufacturing Science (MS) management role will provide process and program direction enabling smooth technology transfers and production execution within Gene Therapy Operations. This role will include leadership of the process transfer team which is responsiblefor technical leadership during platform transfers and technical operation support during manufacturing. The incumbent should be a Subject Matter Expert (SME) in technology transfer and also have experience in the AAV production process (Starting Materials, Drug Substance and/or Drug Product).

What You’ll Do
  • Lead and manage the manufacturing sciences process transfer team. Hire a team of subject matter experts to support technology transfer and process readiness. Act as a site technical expert for AAV production / manufacturing supporting the site’s end to end production scope
  • Provide technical expertise in support of process transfer and process improvement activities. Participate on cross-functional process implementations and process improvement teams, collaborating with technical development, and working with engineering & operations on full scale process equipment. Prepare, review, and approve process readiness and change proposals in concert with regulatory requirements. Lead technical and risk assessment activities to assure smooth transition of processes to GMP operations
  • Provide technical support on process deviations (and corrective actions) that occur during production. Author technical reports, protocols, and regulatory documents, support investigations and write campaign summaries. Participate in regulatory audits and with internal quality support process and batch review. Provides technical oversight for the development of procedures, batch records, and training modules for new or modified processes
  • Communicate and collaborate across levels (Gene Therapy Mfg Site and Global Manufacturing Science Leadership and Internal and external partners) driving clarity in process transfer and program/platform evolution, written and verbal communication examples include, technology transfer plan, GMP documents technical review, raw material planning with procurement, and operations/production team integration
  • Provide advanced knowledge in viral gene therapy technologies and GMP manufacturing processes, understanding of industry guidelines and practices, Ability, and agility to support process fit and process change control controls, ensuring all documentation is accurate to support new and existing programs. The incumbent must have excellent task and project management skills and be able to work in a highly collaborative environment. Limited travel may be required (domestic and/or international)

Who You Are

You have strong gene therapy technical program leadership skills with proven success. You are a strong team-oriented communicator, dedicated to contributing to the generation of pioneering gene therapies for our patients.

Qualifications

Education
  • Bachelor’s degree (BS) in science / engineering / technical field with 8/10 years of relevant experience
  • Master’s in science / engineering / technical field with 6/8 years of relevant experience
  • PhD in science / engineering / technical field with 2/5 years of relevant experience

Required Skills
  • Experience in Technology Transfer
  • Understanding of quality and control systems in the GMP environment
  • Understanding of the gene therapy (AAV) manufacturing process
  • Understanding of operational functions/areas such as Manufacturing, Technical Development, Quality, Warehouse, Procurement, and Regulatory
  • Experience in personnel management and people development
  • Experience in technical project and program management




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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