We are currently seeking a Process Development Senior Associate Scientist / Scientist I to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and execution of the laboratory experiments and protocols for upstream process development efforts. The candidate will execute process development protocols/studies to optimize procedures for unique viral vector platform process and to assist in the transfer of client programs. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.
This position reports to the Associate Director of Upstream Process Development and is responsible for planning and conducting experimental approaches for optimized upstream production of recombinant adeno-associated virus (rAAV) vectors. The Senior Associate Scientist / Scientist I will be directly involved in the development of protocols for maintenance, transfection, and infection of mammalian and insect cell lines in shake flasks and single-use bioreactors. Work activities will also include authoring and reviewing research studies, compiling experimental data, and contributing to protocols and study reports and/or publications with minimal supervision. It is expected that you will work as a member of the development team while accomplishing the timely completion of assignments and reporting of unexpected technical issues.
- Maintain cell growth, transfection, and infection of mammalian and insect cells for baculovirus and rAAV manufacturing using shake flasks and single-use bioreactors
- Assist in the 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
- Compile experimental data with minimal oversight and contribute results for publications or reports
- Support internal process transfer activities from Process Development to GMP
- Delivering results in a high paced environment
- Train and mentor junior laboratory technicians
- Maintain equipment and workspace in an orderly and clean manner
- Serve as a Subject Matter Expert for single-use bioreactors and methods
- Additional responsibilities not listed may be assigned as needed by leadership
- Master's degree with min. 2 years direct experience, or Bachelor's Degree with min. of 4 years industry experience
- Experience with suspension cell culture at all scales: flasks, bench-top bioreactors, and large-scale single-use bioreactors is required
- Technical proficiency required for aspects of cell line growth and production of biological product
- Experience with production of biologics and performing bioassays is preferred
- Working knowledge of cGMP requirements 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
- In our commitment to safety of our employees and customers a COVID vaccination and booster is required