Role: GMP Operations Senior Scientist (Cell Culture)
About the Company:
The biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that we work with is committed to taking innovative gene treatments from concept to market. Situated in the center of Columbus, Ohio, the business has grown to occupy three buildings totaling over 250,000 square feet. This company is responsible for preclinical non-cGMP activities, and is devoted to cGMP manufacturing, and researching cGMP plasmid manufacturing.
Responsibilities:
- Ensure top performance from the production staff. Be a collaborative, guiding, and influencing member of the production team.
- Assign work to production workers to guarantee that client and corporate deliverables are completed on time and with the right metrics.
- Carry out the scaling up of adherent and suspension cell lines to facilitate continuous large-scale manufacturing.
- Address all concerns, troubleshoot production problems, and offer possible solutions to sustain productive production activities.
- Assist the supply chain in material requisitioning and disposal. To meet production objectives, make sure material deadlines are fulfilled.
- Develop, oversee, and oversee the implementation of change requests (CR) and corrective and preventative actions (CAPA) required to guarantee that production modifications and enhancements are carried out on schedule.
- Oversee all facets of the client batch record requirements and production paperwork, following the established GDP standards.
What you can expect when working at this company
- The pride of contributing to the development and manufacturing of life-saving therapies.
- The invaluable experience of being a part of building the foundation of a new organization.
- The opportunity to work alongside experts who have over 10 years in the gene therapy field.
- Competitive compensation
- Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
- 160 hours of Paid Time Off annually
- 11 Company Paid Holidays plus 2 floating holidays annually.
- Company Paid Life Insurance
- 401(k) Match
- Company Paid short and long-term disability.
- 4 weeks of Paid Parental Leave for birth and adoption
- Adoption Assistance
- Tuition Reimbursement and Student Loan Repayment Assistance
- Company Paid LinkedIn Learning access.
- Employee Assistance Programs
- Flexible work options (role specific)
