|Date Posted||January 3, 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
Senior Scientist, Analytical Development – Mass Spectrometry (MS)
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 position will contribute to and support the activities of the Analytical Development Group. This position will use advanced technologies to analyze samples from the cell line, upstream and downstream process development areas. S/he is responsible for independently developing and demonstrating the robustness of new analytical methods and transferring the methods internally or from/to clients.
S/he uses comprehensive knowledge of applicable principles, concepts and practices and/or techniques to lead complex projects within a department, group, or team.
Applies technical and functional knowledge to design experiments/projects that contribute to overall direction of department/discipline.
Applies technical and functional knowledge to job related duties on most projects/ assignments within own group/project team.
This is a permanent, full time position. It is an salaried role. The shift is Monday-Friday 8am-4pm.
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.
This position will perform a variety of laboratory procedures in Analytical Development. The position will perform daily work assignments accurately and in a timely and safe manner. This position will independently evaluate, select and apply standardized scientific and techniques to assignments of moderate complexity, involving potentially conflicting design requirements, unavailability of materials or processes, etc. This position seeks continual improvement of work practices from experience with moderate-sized projects; develops extensions to existing methods and protocols.
- 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.
Trainer/ Coach/ Mentor
- Trains others on procedures and laboratory techniques. Trains, coaches or mentors others on technical, personal development or business issues
Client Interactions/ Project Leadership
- Participates in internal and client meetings, offering technical support and leading the project.
- Identify and recommend business opportunities across projects/sites.
Other duties as assigned
- M.S./M.A. in Biotechnology, or related field, with minimum of 1 years’ experience in related work with no prior experience; or
- B.S./B.A. in Biotechnology, or related field, with minimum of 2 years’ experience in related work; or
- Associates Degree/Certificate/Diploma in laboratory science with minimum of 4 years’ experience in related laboratory work.
- High School Diploma or equivalent with a minimum of 5 years’ experience in related laboratory work.
- Hands-on expertise in developing/optimization/troubleshooting/execution of methods for one 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.