Group Leader Analytical Development

Group Leader - Analytical Development

Position Summary:

• Work Schedule: M-F 8am-5pm
• 100% on-site

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small fast-growing business backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison 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 Alzheimers.

Catalent Pharma Solutions in Madison WI is hiring a Group Leader - Analytical Development. The 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 Catalents 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 sites 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 teams 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

The Role:

• 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.

The Candidate:

• 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 both direct experience in method development and experience leading teams
  engaged in development of a variety of analytical methods and platforms including several of the
  following: SDS-PAGE/Agarose Gel analysis ELISA and Western Blot analysis various U/HPLC based
  methods CE cIEF product binding/activity assays LC-MS qPCR and Sanger Sequencing

Why you should join Catalent:

• 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- Let us help you finish your degree or start a new degree!

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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.

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 . 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.

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