Group Leader - Analytical Development

Overview

Group Leader
- Analytical Development

Position Summary:

Work Schedule:

M-F 8am-5pm. 100% on-site.

Catalent Biologics is investing in people and capabilities. This is a unique opening to join a small, fast-growing team backed by a global public company, with opportunities for career development as the business grows.

Catalent Pharma Solutions in Madison, WI is hiring a Group Leader
- Analytical Development. The Analytical Development team evaluates client analytical methods and optimizes/develops methods to support cell line, upstream, and downstream development, and transfers them to the QC department for phase-appropriate validation. The team characterizes primary and high-order structures, confirms product comparability across scale, and establishes product degradant profiles and specifications for reference standards of mRNA proteins/mAbs generated at Catalent’s Madison site.

The team applies the concepts of analytical quality by design (AQbD) in compliance with FDA and other regulatory requirements and in conformance with the site’s GMP quality systems. The role requires maintaining laboratories and instruments per GM/L/D/P practices and meeting schedules/milestones for method development and sample testing, with data integrity as a priority. The team’s work supports project success in cell line and process development and technology transfer, and in establishing product critical quality attributes (CQA) for regulatory filings.

• Supervise daily team operations, including workload management, training, and providing technical and administrative guidance across functions
• Hire, train, motivate, develop, and evaluate staff while driving a high-performance team environment
• Ensure clear communication and adherence to detailed written and verbal instructions across the team
• Take timely corrective actions in alignment with company policies and performance expectations
• Foster cross-functional collaboration across Project Management, Product Development, Manufacturing, and Quality teams
• Ensure compliance with federal, state, and local regulations, partnering with HR as needed
• Oversee maintenance of laboratories, equipment, and EHS standards, including 5S, calibration, and troubleshooting support
• Ensure timely delivery of high-quality results, maintaining data integrity and alignment with project milestones
• Interface with clients, lead responses to inquiries, and oversee development of reports, presentations, and batch records
• Provide subject matter expertise, drive document standardization and continuous improvement, and support business strategy while coaching team members on performance and career development
• Other duties as assigned.

• PhD in Biotechnology or related field with minimum of 2 years’ experience in related laboratory work/laboratory leadership role; OR
• M.S./M.A. in Biotechnology or related field with minimum of 5 years’ experience in related laboratory work/laboratory leadership role; OR
• B.S./B.A. in Biotechnology or related field with minimum of 8 years’ experience in related laboratory work/laboratory leadership role
• The ideal candidate has direct experience in method development and leading teams developing analytical methods and platforms, including SDS-PAGE/Agarose Gel analysis, ELISA and Western Blot, various U/HPLC methods, CE, cIEF, product binding/activity assays, LC-MS, qPCR, and Sanger Sequencing

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• 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 to help bring life-saving and life-enhancing products to patients worldwide. Catalent is an exciting and growing international company working with pharma, biopharma and consumer health…