|Date Posted||February 10, 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 Associate, Quality Control- Stability
The Quality Control (QC) team is responsible for testing products, raw materials and the manufacturing environment to ensure the Safety, Quality, Identity, Purity and Potency produced by the Catalent Madison Biologics facility.
This position requires a variety of skills necessary for biotech company operations. Perform routine testing of process samples, raw materials, finished products and stability samples, while adhering to SOPs and working in a cGMP compliant environment. This position will analyze and interpret results in written and oral format. Additionally, this position will support Preventative Maintenance and basic Laboratory maintenance activities while maintaining a GMP quality system. Other duties will include data review/archiving, database entry/review and contributions to process improvement initiatives.
This is a full time, permanent role. First shift M-F, however if candidate is open to flexible scheduling partial evening/weekend hours there is potential for this.
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.
- Ability to complete investigation, deviation, and change control forms independently.
- Ability to problem solve to initiate and execute/monitor corrective action.
- Proficient in operation and troubleshooting of a wide variety of instrumentation and data systems.
- Experience with HPLC, SDS-PAGE, cIEF, and ELISA for the analysis of pharmaceuticals.
- Ability to develop Proficiency with Trackwise (R) quality management software.
- Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.
- Good working knowledge of quality systems and risk management.
- M.S./M.A. in Biotechnology, or related field, with no prior experience; or
- B.S./B.A. in Biotechnology, or related field, with minimum of 3 years’ experience in related laboratory work; or
- Associates Degree/Certificate/Diploma in laboratory science with minimum of 4 years’ experience in related laboratory work.
- Experience operating, maintaining, and troubleshooting sequencing techniques.
- Aseptic technique experience.
- Mammalian cell culture experience is preferred.
- Preferred – HPLC, SDS-PAGE, Western Blot, HPLC, cIEF and ELISA experience
- cGMP documentation practices.
- Experience writing standard operating procedures
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 19 days of paid time off annually + 8 paid holidays
- Competitive salary with yearly bonus potential
- Community engagement and green initiatives
- Generous 401K match and Paid Time Off accrual
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement
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