|Date Posted||June 2, 2021|
|Address||726 Heartland Trail, Suite 100|
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
Sr. Scientist, Analytical Development
The Analytical Development team is responsible for developing analytical methods to support cell line, upstream, and downstream development, and performing robustness assessments of the methods prior to transferring them to the QC department. The team is also responsible for characterizing primary and high order structures of manufactured protein biopharmaceutical products.
This is a permanent, full time position. It is a salaried role. The shift is Monday-Friday 8a-5p.
Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers’ growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
- Develop and execute laboratory work plans/schedules independently, using customer milestones/and Division/site performance standards and metrics
- Develops and reviews statement of work and ensures project stays within scope
- Authors and may approve technical documents, such as protocols, test methods, test reports, certificates of analysis, and operating procedures
- Review technical documents for accuracy, thoroughness and regulatory compliance
- Trains others on procedures and laboratory techniques. Trains, coaches or mentors others on technical, personal development or business issues
- Participates in internal and client meetings, offering technical support and leading the project
Education or Equivalent:
- Ph.D. in Biotechnology, or related field with at least 2 - 4 years of laboratory experience, preferably in an industrial setting.
- MS in Biotechnology or related field with at least 5 - 10 years of industry laboratory experience.
- B.S/B.A. in Biotechnology, or related field with at least 8 - 15 years of industry laboratory experience.
- Hands-on expertise in developing/optimization/troubleshooting/execution of methods for two or more of the following: HPLC/UPLC (including but not limited to RP-HPLC, SEC and IEX), CE and iCE (cIEF) SDS-PAGE, Western, and ELISA and other general biochemical analyses/methods for protein/mAb analysis
- Expertise with biophysical methods for protein/mAb characterization, such as MS, CD, DSC, MFI, and light scattering, is a plus
- Experience writing standard operating procedures and development reports
- Strong understanding of GMP documentation and guidelines
- Experience with assessment of method robustness (assay performance characterization) required to support phase appropriate method qualification
- Familiarity with requirements for phase appropriate method validation and testing