We are currently seeking a Process Development Scientist I/II to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and execution of the laboratory experiments and protocols for downstream process development efforts. The candidate will write and execute process development protocols/studies to optimize procedures for unique plasmid DNA platform process and to assist in client productions. 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 a Senior Scientist in Plasmid Process Development and is responsible for planning and conducting experimental approaches for optimized downstream purification of plasmid DNA. The Scientist I will be directly involved in the development of protocols for lysis, clarification, chromatography, and tangential flow filtration (TFF) process steps. The position may include some assistance in upstream fermentation related operations. 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.
- Perform chromatography and filtration processes including microfiltration, depth filtration, tangential flow filtration, and sterile filtration.
- Assist in upstream fermentation technologies related to plasmid production using single use fermenters, shake flasks, harvest, lysis and clarification.
- Compile experimental data with minimal oversight and contribute results for presentations, 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 purification equipment and methods
- Additional responsibilities not listed may be assigned as needed by leadership
- Bachelor’s degree with 6+ years’ relevant experience; or Master’s degree with 4+ years’ direct experience, or Ph.D. in biological sciences/engineering and relevant experience
- Technical proficiency required for aspects of purification of plasmid DNA.
- Broad understanding of downstream purification techniques; experience with GE AKTA systems (Pure, Avant, Pilot) FPLC or tangential flow filtration is highly preferred
- Working knowledge of fermentation techniques.
- 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 is required.
- This position reports to Senior Scientist (Downstream)
- Travel on an intermittent basis is required (approximately 5-10%) to support job responsibilities and commitments.