Group Leader - Analytical Development

Catalent Pharma Solutions • Madison, WI

6d • Onsite

About The Position

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 mRNA proteins/mAbs generated at Catalent’s Madison site. The team executes on this by applying the concepts of analytical quality be design (AQbD)in compliance with FDA and other regulatory agency requirements and in conformance with the site’s GMP quality systems. Success requires that laboratories and instruments are maintained in accordance with Good Manufacturing, Laboratory, and Documentation Practices (GM/L/D/P), schedules/timelines/milestones for method development and sample testing are met, and that the integrity of generate data is confirmed. The team’s role is therefore central to the success of projects that enter cell line and process development and technology transfer workstreams. It also ensures that analytical methods can be applied in establishing product critical quality attributes (CQA) and supporting regulatory filings with methods and studies that are essential in demonstrating the high quality of drug products generated for our clients and their patients.

Requirements

• 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.
• Direct experience in method development
• Experience leading teams engaged in development of a variety of analytical methods and platforms

Nice To Haves

• SDS-PAGE/Agarose Gel analysis
• ELISA and Western Blot analysis
• various U/HPLC based methods
• CE
• cIEF
• product binding/activity assays
• LC-MS
• qPCR
• Sanger Sequencing

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level