|Date Posted||August 12, 2020|
|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
Scientist, Analytical Development
The Analytical Development team is responsible for developing analytical methods to support cell line, upstream, and downstream development, and transferring them to the QC department. The team is also responsible for characterizing primary and high order structures of proteins/mAbs.
The scientist will be responsible for supporting testing and method development of samples from cell line, upstream process development as well as downstream process development to support physicochemical characterization of proteins to determine quality attributes to confirm the quality, consistency and stability of biological products. This position will be capable of independently developing a variety of High Performance Liquid Chromatography (HPLC), Mass Spectroscopy (MS), Activity/Potency binding, Circular Dichroism (CD), Capillary Isoelectric Focusing (cIEF) and/or Capillary Electrophoresis (CE) methods and performing daily work assignment accurately and in a timely and safe manner. The Scientist will serve as a lead for technical advice and perform multiple complex projects at a time.
This position is targeting individuals with experience in the characterization of protein/mAb through Mass Spectroscopy (MS) testing. The ideal candidate would also have familiarity with experimental design/design of experiments (DOE).
This role contributes to the patient first philosophy by ensuring quality of data generated in Analytical Development. This position is critical to the patient first philosophy because it confirms tests were executed according to the defined procedures, and results are accurate so that clients can make informed decisions about their products.
- Develops/optimizes the range of methods identified above to analyze protein and mAb samples to support process development at different stages
- Understands and applies method qualification and validation per the ICH guidelines
- Development and transfer of analytical methods to support clinical phase and commercial processes
- Troubleshoots and solves analytical instrument problems
- Troubleshoots and problem solves for analytical methods in order to initiate and execute/monitor corrective actions Reviews qualification and validation protocols and reports.
- Writes procedural SOPs and reports
- Ph.D. Chemistry/Biochemistry with 0-2 years experience in biotech industry or post-doc training in protein MS; or MS with 3-5 years experience; or B.S/B.A. with 5-8 years experience
- Experience with biophysical, biochemical methods for protein and mAb characterization, such as Mass Spectroscopy (Mass Spec) for Total Mass determination, Peptide Mapping and N-Glycan analysis
- Experience with application of statistics to support data analysis
- Experience mentoring junior staff regarding laboratory procedures
- Experience with CD, DSC, MFI, and light scattering, is a plus
- Experience in method development, validation and application experience for analysis of clinical and commercial products in a GMP environment is a plus
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- Fast tracked career growth, with annual performance review and feedback process
- Competitive base salary with other compensation incentives including yearly incentive plan
- Medical, Dental, Vision, and 401K are all offered on day one of employment
- 19 days of Paid Time Off (PTO) + 7 paid holidays
- Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention!
- Defined career path and annual performance review and feedback process