Scientist / Senior Scientist, Drug Product Formulation-CMC
Generation Bio, United States
Job Description
Generation Bio is a biotechnology company leading a new generation of gene therapy. With our proprietary re-dosable ceDNA technology, we are expanding the reach of gene therapy. At Generation Bio, our goal is to bring the life-saving benefits of gene therapy to more people, living with a broader range of diseases, in more places around the world. Our vision is to make the ravages of genetic disease as imaginary to the next generation as polio feels to children today.
We are a thriving, collaborative, creative community of diverse talents, beliefs, and experiences relentlessly dedicated to our mission. Founded and launched by Atlas Venture. Headquartered in Cambridge, Massachusetts. Committed to a future where more people can live full lives.
Delve further. Please visit www.generationbio.com or follow @generationbio.
SUMMARY
Generation Bio seeks an energetic and highly driven hands on Scientist to conduct manufacturing and process development operations for drug product formulations using lipid nanoparticle platforms. The successful candidate will report to the Director, DP-CMC and will be an integral part of a cross functional team optimizing novel approaches for delivery for our gene therapy platform.
RESPONSIBILITIES:
- Oversees and performs hands-on development work for the manufacturing processes for Drug Product formulations using both DNA vectors and Lipid Nanoparticles (LNPs).
- Plans, organizes, and takes ownership of manufacturing activities required to support research and pre-clinical testing of Drug Product.
- Designs and performs process development/optimization experiments to scale up production of Drug Product.
- Supervises, trains, and mentors a small team of Associate Scientists.
- Manages the day to day materials, equipment, and other resource requirements to maintain Drug Product output.
- Takes ownership of assigned projects and champions new data-driven ideas to contribute to project advancement.
- Keeps clear and transferable records of experiments, updates protocols, writes technical reports and data summaries to detail manufacturing and process development work.
- Works with other functional groups across the company to coordinate timelines and deliverables, and to stay abreast of overall project goals.
- Supports the management of external, technical interfaces to contract manufacturing organizations.
QUALIFICATIONS:
- Minimum of B.S. with 8+ years experience, M.S. with 6+ years experience, or Ph.D. with 0+ years of related experience in the pharmaceutical industry. Degree in Pharmaceutics, Materials Science, Polymer Chemistry, Chemical Engineering, Chemistry, Biochemistry, or related field.
- Background in nucleic acid formulation is highly desired for this role. Specific background in LNPs or other nanoparticle technologies is a strong plus.
- Strong interpersonal, organizational, and communication skills are required for this role.
- Proven track record of working effectively with cross functional teams including research and development, pre-clinical, manufacturing operations, and quality control.
- Knowledge of GxP regulations and QbD principles are helpful.
- Demonstrated ability to operate in a fast-paced environment.
- Demonstrate a sense of urgency; proactive thinking and multitasking are essential.
- Results-driven with excellent attention to details.
- Proven ability to effectively plan and organize complex work activities and prioritize task completion to meet schedules and deadlines.
POSITION: Full-Time, Exempt
EEOC Statement: Generation Bio believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, gender, religion, national origin, gender identity, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.