Manager, Research Manufacturing

We are currently seeking a Manager of Research Manufacturing to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and oversight of upstream and downstream vector production. The candidate will lead a team of skilled technicians and scientists to produce research and toxicology grade rAAV vectors. The ideal candidate will be an expert in technical problem-solving, laboratory techniques, and developing interorganizational relationships to support our growth in the Gene Therapy sector.

This position is responsible for overseeing production of research-grade recombinant adeno-associated virus (rAAV) vectors in mammalian and insect cell lines. The incumbent will offer hands-on leadership of the production group utilizing shake flasks and single-use bioreactors for upstream work, and FPLC systems, tangential flow filtration, centrifugation, and other downstream purification technologies. Work activities will also include scheduling, equipment management, preparing protocols and study reports related to production work with minimal supervision. The Manager will review relevant literature, data of team scientists and associates, and ensure that all staff are properly trained. It is expected that the incumbent will work independently while accomplishing the timely completion of assignments and necessary resolution of unexpected technical issues.

The individual chosen for this position will work in close partnership with manufacturing leadership, and external parties to support manufacturing of vector candidates. The Manager will also work closely with the Directors of Process and Analytical Development to facilitat seamless movement of projects through the development continuum. The focus of this leadership role is to employ novel approaches to ensure Forge provides and maintains a state-of-the-art rAAV manufacturing platform process for viral vector products, working in close partnership with internal and external experts to realize this goal. To this end, the Manager of Research Manufacturing will keep current on new technologies, and regulatory requirements that may have an impact on the company’s development and manufacturing plans.

Responsibilities:

• Schedule and adhere to daily, weekly, and monthly production targets for internal and external clients
• Organize workflow and clearly communicate duties and tasks to direct reports
• Participate, oversee, and communicate priorities for the execution of upstream and downstream manufacturing procedures for simultaneous batches
• Maintaining cell growth, transfection, and infection of mammalian and insect cells for baculovirus and rAAV manufacturing using shake flasks and single-use bioreactors
• Execution of downstream purification technologies related to rAAV purification using chromatography (affinity and ion-exchange) and filtration processes including microfiltration, depth filtration, tangential flow filtration, and sterile filtration
• Assist in the production of preclinical and toxicology materials in a laboratory setting
• Preparing protocols and reports in notebooks and electronic documents
• Train junior staff in the various upstream, downstream, and analytical techniques
• Oversee inventory management for the group in coordination with materials management group to keep lab well stocked and organized
• Track production and quality metrics
• Interface with other departments (Analytical Development, Process Development, Program teams, etc.) as necessary
• Communicate production schedule and vector data to management, program managers, and clients
• Ensure that operations adhere to the plant schedule and critical activities are always performed within the allotted timeframes
• Support business development activities including vendor and contract manufacturer selection as well as resource and response generation for bids and project budgeting
• Support future business evolution through process knowledge expansion and supporting internal product and process development activities
• Additional responsibilities not listed may be assigned as needed by leadership.

Requirements:

• Bachelor’s degree with 5+ years’ relevant experience; or Master’s degree with 3+ years’ direct experience, or Ph.D. with the completion of a postdoctoral fellowship in biological sciences or two years’ of relevant experience in biopharmaceutical manufacturing/R&D
• Technical proficiency required for aspects of production of biological products
• Experience in production of viral vectors is preferred
• Broad knowledge of cell culture techniques is required; experience with bioreactors is preferred
• Working knowledge of downstream purification techniques; experience with GE AKTA systems (Pure, Avant, or Pilot) or Bio-Rad NGC FPLC systems is highly preferred
• Experience with production of biologics and performing bioassays is preferred
• Previous experience in training and oversight of direct reports is required
• Experience working in a cGMP environment is preferred
• Must be self-motivating, organized and proactive
• Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
• Ability to work hours necessary to support production and/or product transfer activities
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and cleanroom gowning attire as needed

Reporting Outline:

• This position reports to the Director of Small Scale Manufacturing
• Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments