Group Leader - Analytical Development

Catalent Pharma Solutions; Madison (AL); On-site; USD 120,000 - 155,000; Full time

Job summary

Catalent Pharma Solutions in Madison, Wisconsin is seeking a Group Leader to guide a team of 5–10 scientists in analytical development for biologics programs, including proteins, monoclonal antibodies, and emerging modalities such as mRNA. You will lead method development, optimization, characterization, and tech transfer with a focus on quality and compliance.

This role requires strong leadership, cross-functional collaboration with project management, QA, manufacturing, and development teams,

Qualifications

• PhD or equivalent with leadership experience in a lab setting.
• Analytical method development experience in a biologics or biopharmaceutical environment.
• Proven laboratory leadership and cross-functional collaboration.
• Experience in a GMP-regulated environment.

Responsibilities

• Lead, mentor, and develop a team of 5–10 scientists with technical guidance and career development.
• Manage priorities, workloads, and resources to deliver analytical development projects on schedule.
• Oversee method development, optimization, characterization, and tech transfer for biologics programs.
• Review and approve scientific data, reports, and GMP documentation to ensure quality and compliance.
• Serve as primary client-facing representative for Analytical Development and communicate progress.
• Collaborate cross-functionally with PM, Quality, Manufacturing, and other stakeholders to hit milestones.

Skills

Leadership

Communication skills

Client engagement

GMP awareness

Education

PhD in Biotechnology / Biochemistry / Molecular Biology / Analytical Chemistry

Master's degree in related discipline with leadership experience

Bachelor's degree with extensive leadership experience

Job description

Group Leader - Analytical Development

Catalent is seeking Group Leaders to join our growing Analytical Development team in Madison, Wisconsin.

This is an exciting opportunity for those who are passionate about analytical method development, people leadership, and client collaboration. In this role, you will lead a team of scientists responsible for developing, optimizing, characterizing, and transferring analytical methods that support a diverse portfolio of biologics programs, including proteins, monoclonal antibodies (mAbs), and emerging modalities such as mRNA therapeutics.

As a Group Leader, you will combine technical expertise, leadership, and cross-functional collaboration to help advance client programs from development through GMP manufacturing while ensuring the highest standards of quality, compliance, and scientific excellence.

About Catalent Madison

Catalent's Madison, Wisconsin facility is a state-of-the-art biologics development and manufacturing site supporting customers from research through early- and mid-stage clinical production. Located at 726 Heartland Trail, the 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance manufacturing, and biopharmaceutical process development.

The site is home to Catalent's proprietary GPEx® and GPEx® Lightning technologies, enabling the generation of high-producing mammalian cell lines for biologic therapies. With production capabilities ranging from 50L to 4,000L and a recent $45 million expansion, the Madison campus continues to play a critical role in Catalent's global biologics network while supporting Wisconsin's growing life sciences industry.

Location: 100% Onsite at our facility in Madison, Wisconsin
Shift: Monday – Friday, First Shift

Key Responsibilities

• Lead, mentor, and develop a team of 5–10 scientists by providing technical guidance, coaching, performance feedback, and career development support.
• Manage team priorities, workloads, and resources to ensure analytical development projects are executed successfully and delivered on schedule.
• Oversee analytical method development, optimization, characterization, and technology transfer activities supporting biologics development programs.
• Review and approve scientific data, technical reports, and GMP documentation to ensure quality, compliance, and data integrity.
• Serve as a primary client-facing representative for Analytical Development by participating in meetings, communicating project updates, and addressing technical questions.
• Collaborate cross-functionally with Project Management, Quality, Manufacturing, Process Development, Cell Line Development, and other stakeholders to achieve program milestones and drive continuous improvement.
• Other responsibilities as needed.

Required Qualifications

• PhD in Biotechnology, Biochemistry, Molecular Biology, Analytical Chemistry, or related scientific discipline with a minimum of 2 years of laboratory leadership experience, or master's degree in a related scientific discipline with a minimum of 5 years of laboratory leadership experience, or bachelor's degree in a related scientific discipline with a minimum of 8 years of laboratory leadership experience
• Analytical method development experience within a biologics or biopharmaceutical environment
• Previous laboratory leadership experience
• Experience managing multiple priorities, projects, and timelines
• Strong written and verbal communication skills
• Ability to effectively engage with clients and cross-functional stakeholders
• Experience operating within a GMP-regulated environment

Preferred Qualifications

• Experience with the following analytical techniques: ELISA (highly preferred), Western Blot, SDS-PAGE. Agarose Gel Electrophoresis, HPLC/UHPLC, Capillary Electrophoresis (CE), cIEF, Product Binding and Potency Assays, LC-MS, qPCR, Sanger Sequencing
• Experience in biologics, protein, monoclonal antibody (mAb), and/or mRNA analytical development highly preferred
• CDMO, CRO, or biopharmaceutical industry experience

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 [e-mail]. 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.