Assistant/Associate Scientist - Aseptic Process Development
About The Position
The Assistant/Associate Scientist will support laboratory studies related to manufacturing process improvements, investigations, material qualification, comparability, and validation activities. This role will execute experiments in process development laboratories using aseptic techniques and automated process equipment, summarize and analyze experimental data, coordinate process samples with analytical teams, and support technical documentation and manufacturing investigations. The position works closely with cross-functional teams and requires strong organization, communication, problem-solving, and technical writing skills.
Requirements
- BS degree in Biological Sciences, Chemical Engineering, Biomedical Engineering, Life Sciences, or a related discipline with 2+ years of relevant experience, or MS degree with 0+ years of relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
- Hands-on aseptic technique or aseptic processing experience.
- GMP or GLP experience.
- Technical writing experience, including drafting SOPs, protocols, reports, or similar technical documentation.
- Ability to execute laboratory studies and summarize experimental data.
- Strong problem-solving, critical-thinking, communication, and time-management skills.
- Ability to work effectively in cross-functional teams, meet deadlines, and prioritize responsibilities.
- Authorization to work in the United States without visa sponsorship.
Nice To Haves
- Cell therapy process development or manufacturing experience.
- GMP manufacturing experience or additional GLP/GDP experience.
- Cell culture and cell passaging experience.
- Blood processing or cell-isolation experience.
- Experience supporting commercial manufacturing investigations, validation, or comparability activities.
- Experience working within MSAT, Quality, or Process Development teams.
- Experience operating automated process equipment.
- Data-analysis experience using JMP, Excel, coding, or related approaches.
- Experience supporting commercial product activities, including ongoing validation, comparability, or post-marketing commitments.
- Operational excellence training or background.
Responsibilities
- Support laboratory studies related to manufacturing process improvements, investigations, material qualification, comparability, and validation activities.
- Execute experiments in process development laboratories using aseptic techniques and automated process equipment.
- Summarize and analyze experimental data.
- Coordinate process samples with analytical teams.
- Support technical documentation and manufacturing investigations.
Benefits
- Health insurance with dental and vision insurance options.
- Holiday pay.
- 401(k) program.
- Employee referral bonus program.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
