Sr. Associate Scientist, Analytical Development | Madison, WI

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 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. The Analytical

Development team is responsible for evaluating client analytical methods and/or optimizing/developing methods required to support cell line, upstream, and downstream development, and transferring them to the QC department for phase appropriate validation.

The team is also responsible for characterizing primary and high order structures; confirming product comparability across scale and establishing product degradant profiles and specifications for reference standards of m RNA proteins/m Abs generated at Catalent's, Madison site. The team executes on this by applying the concepts of analytical quality by design (AQb D) in compliance with FDA and other regulatory agency requirements and

in conformance with the sites GMP quality systems. The team's role is therefore central to the success of projects that enter cell line and process development and technology transfer workstreams and also ensures that analytical methods can be applied in establishing product critical quality attributes (CQA) and supporting IND-enabling studies and applications that are essential in providing high quality drug products for our clients and their patients.

This is a full-time on-site salaried position, Monday - Friday 9:00am to 5:00pm 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.

The Role: Understand and apply biochemical/biophysical and immunological concepts associated with macromolecules including proteins, nucleic acids, and lipids and the methods for analysis Execute all activities related to the analysis of proteins and other biological macromolecules from mammalian cell culture and process development ranging from SDS-PAGE/Agarose Gel analysis, ELISA and Western Blot analysis, various HPLC based methods, CE, c IEF, product binding/activity assays, and Sanger Sequencing Independently support developing robust assays, including use of experimental design (Do E) and applying the principles of AQb D Accurately record experimental data/observations in data sheets or lab notebooks Become fully trained on departmental SOPs, write procedural SOPs as necessary All other duties as assigned The Candidate: Requires High School Diploma/GED with 10+ years of experience OR Associate's degree in STEM discipline with 6-9 years of experience OR B.

S/B. A. in any STEM discipline with at least 3-6 years' experience in a laboratory environment OR MS in STEM discipline with 1-3 years of industry laboratory experience Why you should join Catalent: 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 152 hours 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 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 Catalent Careers 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 xyz X@.

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 xyz X@ for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.