The Sr./Principal Scientist, Upstream Process Development will be part of the Process Development Group reporting to the Director of Process Development. The role will have direct management responsibility for a team of Scientists and Research Associates. The Sr/Principal Scientist is responsible for the Upstream Process development, characterization, technology transfer and GMP manufacturing technical support. This individual will lead or contribute as a core member of various cross-functional teams, and interact extensively with other departments within Genezen, including Analytical Development, Manufacturing, Engineering, and MSAT. This is a client-facing position with regular interaction with our partners including external presentations, driving the technical discussion and program strategy.
JOB RESPONSIBILITIES- Provides technical oversight and strategic input for upstream viral vector drug substance development activities
- Leads, proposes, manages, and coordinates activities on platform improvement/continuous projects in USP labs
- Leads, manages, and supports late-stage development, by identifying tasks, planning, monitoring progress of deliverables, and in terms of protocol and report generation in areas such as scale-down model qualification, process characterization, and scale-down model process validation studies
- Leads and supports technology transfer activities at pilot plant and when necessary, preforms experiments him/herself, focusing scale-up platform process at scale and process improvements implementation, process characterization at scale and bills of materials as well as sampling plans.
- Provides MSAT and manufacturing technical Upstream SME support for process troubleshooting, manufacturing data analysis, root cause analysis, and deviations during GMP production, change controls, CAPAs, CCRs and other Quality Systems documentation as needed.
- Designs and outlines experimental plans to meet the defined Genezen and client objective. Analyses and reviews experimental results and data.
- Performs, optimizes, and maintains linear scale-down models. Writes, reviews, and approves electronic lab notebooks (ELNs) entries, experimental protocols, development reports, process descriptions, and scientific reports
- Presents project progress and results internally to cross-functional teams and externally to clients/stakeholders
- Maintains robust communication with all relevant functions that have an impact on or are impacted by Upstream Process Development
- Coordinates and supervises the activities in the USP labs (with a team of engineers/ (Jr.) bioprocess technologist, co-op students, interns, temporary personnel (contractors), and technical SMEs and when necessary, performs experiments him/herself. Guides junior USP team members by setting goals/tasks on projects
SPECIAL JOB REQUIREMENTS- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredMSc with 8+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines
Essential
PhD with 6+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines
Desired
ON-THE-JOB EXPERIENCEProcess Development and Cell Line Development Experience
Essential
Upstream Processing Experience with Cell Culture, Bioreactor Technologies, and Transfection/Infection approaches
Essential
Prior work experience at a CDMO
Desired
SKILLS / ABILITIESHands-on experience on complex biologics, e.g. gene therapy, viral vaccines, therapeutic proteins
Essential
Experience with technology transfer and GMP manufacturing technical support
Essential
Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems
Essential
Effective communicator with track record of presenting data to relevant stakeholders including external stakeholders
Essential
Experience with DoE design and statistical analysis on large data sets
Essential
Excellent scientific writing skills demonstrated by publications and reports
Essential
Experience with direct management of Scientists and Research Associates including day-to-day oversight and direction and career development and coaching.
Essential
PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment- Regularly sit for long periods of time
Movement- Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting- Frequently lift and/or move up to 10 pounds
- Rarely lift and/or move up to 25 pounds
Vision- Frequently utilize close vision and the ability to adjust focus
Communication- Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN'S BENEFITS- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS- Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
