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Senior Associate Scientist, Process Development, Upstream - Madison Wisconsin
Company: Disability Solutions Location: Madison, Wisconsin
Posted On: 05/04/2024
Position Title:-- Senior Associate Scientist, Process Development, UpstreamM-F 1st shiftSummary:Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.-- The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.-- Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.Working for Catalent Biologics is an opportunity to join an entrepreneurial team.-- Catalent Biologics is making significant investments in people and capabilities.-- This is a unique opening to join a small, fast-growing business, backed by a global public company.-- People joining our team will have the opportunity for career development as our business continues to grow and expand.-- Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer's.The Senior Associate Scientist, Process Development, Upstream will accurately, timely, and safely perform a variety of laboratory procedures and experimental methods in Upstream Process Development that support external client projects and internal technology development work. The Senior Associate Scientist, Process Development, Upstream will involve performing scientific work involving cell bank vial thaws, seed train scale-up, production bioreactor operations (high-throughput, bench-scale, and pilot-scale), and cell culture analytical methods; the project experiments would require the application of platform methods involving mammalian cell culture process variables potentially requiring a substantial degree of investigation to produce processes with optimized productivity and capable of producing product within required product quality specifications.-- This position will also involve more complex projects such as external technology transfers that may vary substantially from the internal platform methods as well as projects requiring more extensive knowledge of cell biology and biochemistry such as those involving biosimilars.-- In addition, this position may also involve leading efforts in platform improvements and technology development initiatives designed to impact multiple projects.-- The experiment design and results will be documented accurately, analyzed using standard statistical methods, and communicated with external clients and other functional areas according to project timelines.-- Finally, this position will support essential lab support assignments including equipment maintenance and cleaning, lab material stocking, general lab cleaning, 5S organization, and other lab support tasks when required. Given the nature of cell culture processes, some weekend work will be required on a rotating schedule with other team members.The Role:-- - Lab work:
- Execute laboratory work plan according to the schedule developed with input from a supervisor or senior team member. Train others on procedures and laboratory techniques.
- Support essential lab support assignments including equipment maintenance and cleaning, lab material stocking, general lab cleaning, 5S organization, and other lab support tasks when required.
- Prepare general lab solutions including cell culture media according to Batch Production Record (BPR) specifications.
- Execute experiments involving cell bank vial thaws, seed train scale-up, production bioreactor operations (high-throughput, bench-scale, and pilot-scale), and cell culture analytical methods that require routine implementation of platform methods that may require an extensive amount of modification to achieve productivity and product quality targets.-- The experiment design and data analysis will involve standard statistical methods including Design of Experiments (DoE) techniques while using statistical software packages.
- Perform external technology transfers that may vary substantially from the internal platform methods and serve as an upstream project lead for projects requiring more extensive knowledge of cell biology and biochemistry such as those involving biosimilars.
- Assist efforts in developing platform improvements and technology development initiatives designed to impact multiple projects.
- Execute project responsibilities involving the maintenance of project timelines, communication of results with clients, and transfer of samples and data to other internal functional areas.
- Perform data entry and maintain BPRs of work performed according to Standard Operating Procedures (SOPs); review batch records for coworkers to ensure consistency.
- Technical writing:
- Author technical documents such as protocols, test methods, development reports, certificates of testing, and operating procedures.
- Technical review:
- Review technical documents for accuracy, thoroughness, and regulatory compliance.
- Trainer/coach/mentor:
- Train others on laboratory techniques.
- Client interaction project leadership:
- Participate in client meetings offering technical support and leading the project.
- Other duties as assigned.The Candidate
- Bachelor's degree in Biotechnology or STEM discipline and 3-6 years related experience, OR
- Master's degree in Biotechnology or STEM discipline and 0-3 years related experience.Position Benefits:
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