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Senior Associate Scientist, Process Development, Upstream

Company: Disability Solutions
Location: Madison
Posted on: June 7, 2024

Job Description:

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:
                • 152 hours PTO & 8 Holidays
                • Medical, Dental & Vision Benefits and 401k
                • Tuition ReimbursementCatalent offers rewarding opportunities to further your career!-- Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.--Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.------personal initiative. dynamic pace. meaningful work.Visit to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.--------Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Madison , Senior Associate Scientist, Process Development, Upstream, Other , Madison, Wisconsin

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