Manager, Biochemical Analysis

Catalent Pharma SolutionsKansas City, MO
Onsite

About The Position

We have an opportunity for a Manager, Biochemical Analysis to join our team. In this role, you will lead sub-teams of group leaders, scientists, and associate scientists, serving as a technical expert and key liaison between clients and internal teams. You will oversee analytical activities for biopharma product development under cGMP guidance, ensuring quality, compliance, and timely delivery. This position also involves mentoring, HR responsibilities, and supporting audits and client interactions.

Requirements

  • Bachelor’s degree with more than 5 years of relevant experience in department-specific techniques and over 2 years of management experience preferred, or based on performance at Catalent.
  • Master’s degree with more than 3 years of relevant experience in department-specific techniques and over 1 year of management experience preferred, or based on performance at Catalent.
  • Doctorate degree with more than 2 years of relevant experience in department-specific techniques and over 1 year of management experience preferred, or based on performance at Catalent.
  • Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Nice To Haves

  • Strong knowledge of principles, theories, and concepts in Biology, Chemistry, or Biochemistry, and broad understanding of related disciplines.
  • In-depth expertise in instrumentation, theory, data interpretation, and applications in at least one technical area, with ability to assess new technologies and their impact on Catalent offerings.
  • Experience in drug development and lifecycle support, with ability to develop strategies to meet regulatory milestones.
  • Excellent written and verbal communication skills for internal and external stakeholders.
  • Ability to explain complex technical information to non-technical audiences.

Responsibilities

  • Manage technical analysis, production scheduling, and resolve operational issues, escalating critical concerns when needed.
  • Oversee people management, including coaching, performance management, and career development. Lead and develop high-performing teams, including group leaders, scientists, and associate scientists.
  • Serve as technical expert on projects and act as liaison between clients and Catalent technical teams.
  • Handle HR activities such as performance reviews, time entry approval, PTO approval, and salary adjustments.
  • Support client audits and visits, and communicate with cross-functional teams on analytical activities for biopharma product development under cGMP guidance.
  • Provide expertise in techniques such as compendial assays, Karl Fischer, UV-Vis, HPLC/UPLC methods, aggregation techniques, electrophoresis, FTIR, CD, fluorescence, DSC, and other technologies as required.
  • Supervise method development, evaluation, transfers, verifications, qualifications, validations, stability studies, and ad hoc sample testing.
  • Plan, prioritize, and execute analytical work in compliance with client contracts and technical agreements. Serve as backup or lead Project Technical Lead as needed.
  • Manage computer system validation activities and ensure equipment compliance. Ensure adherence to cGMP practices and maintain data integrity and quality.
  • Verify analytical data and ensure compliance with SOPs and safety legislation. Assist in project costing, timelines, and monitor budgets and revenue forecasts. Communicate effectively with clients, auditors, peers, and leadership to ensure smooth project execution.
  • Coordinate training needs and maintain team engagement and growth culture. Support marketing and business development activities and stay updated on modern techniques.
  • Identify and implement new technologies and model Catalent’s culture of quality, safety, and ethics.
  • All other duties as assigned

Benefits

  • Defined career path with annual performance reviews and feedback process.
  • Diverse and inclusive culture.
  • Opportunities for career growth within an organization dedicated to improving lives.
  • Competitive paid time off plus 8 paid holidays.
  • Community engagement and green initiatives.
  • Medical, dental, and vision benefits effective from day one.
  • Tuition reimbursement program.
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