Senior Scientist - Analytical Development

We're hiring for a Senior Scientist, Analytical Development to support late-stage development programs in Madison, Wisconsin!

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Senior Scientist, Analytical Development is responsible for accelerating multiple late-stage programs. 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. This is a full-time, salaried position and is 100% site-based. The schedule is Monday - Friday 1st shift.

Catalent's Madison, Wisconsin site is a state-of-the-art biomanufacturing facility specializing in integrated formulation and analytical services. Our site features our proprietary Gene Expression Technology (GPEx) cell line engineering platform, and biomanufacturing capabilities utilizing single-use systems. Our employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer's.

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

• Develops/optimizes assays including but not limited to HPLC, CE, and cIEF to analyze protein and mAb samples to support process development at different stages.
• Understands and applies method qualification and validation (Phase III) per the ICH guidelines.
• Reviews qualification and validation protocols and reports.
• Writes procedural SOPs and reports.
• Experience with development and transfer of analytical methods to support late phase and commercial processes.
• Troubleshoots and solves analytical instrument problems.
• Troubleshoots and problem solves for analytical methods to initiate and execute/monitor corrective actions.
• Acts as the technical lead for Client development projects, communicates project status and effectively provides technical explanation/rationalization.
• Critically analyzes complex data, interprets, and integrates experimental results with project objectives.
• Other duties as assigned.

The Candidate

Educational qualifications:

• Ph.D. in Chemistry or Biochemistry with a minimum of 2 years of experience in the biotechnology industry or post-doctoral training in protein MS.
• Master's degree in chemistry or Biochemistry with a minimum of 5 years of experience in the biotechnology, or related, industry.
• Bachelor's degree in chemistry or Biochemistry with 8+ years' experience in the biotechnology, or related, industry.

Highly preferred qualifications:

• Hands-on experience in developing MS, LCMS, and HPLC/UPLC methods for protein and/or mAb analysis, including but not limited to: RP-HPLC-MS; SEC-HPLC-MS; IEX-HPLC-MS.
• Familiarity with biophysical methods for protein and mAb characterization, such as Peptide Mapping, N-Glycan, CD, DSC, MFI, and light scattering.
• Method development and method gap assessment experience for Phase III and commercial products.
• Knowledge and experience working in a cGMP environment, while using Good Documentation Practices (GDP).
• Experience mentoring junior staff regarding laboratory procedures.

Why you should join Catalent

• Defined career path and annual performance review and feedback process.
• Medical, dental and vision benefits effective on first day of employment.
• Potential for career growth on an expanding team and organization.
• 152 hours of paid time off annually plus 8 paid holidays.
• Community engagement and green initiatives.
• Competitive salary with bonus potential.
• Tuition reimbursement program.
• Diverse, inclusive culture.
• Generous 401K match.

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.