Manager, Biochemical Analysis
Kansas City, MO - USA
Job Summary
Manager Biochemical Analysis Role
About Site
Catalents Kansas City facility is home to our Oral & Specialty Drug Delivery Biologics Analytical Services and Clinical Supply Services businesses.
Position Summary
We have an opportunity for a Manager Biochemical Analysis to join our 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.
Shift: Monday - Friday Day Shift
Location: Kansas City MO
100% Onsite
The Role
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 Catalents culture of quality safety and ethics.
All other duties as assigned
The Candidate
Bachelors 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.
Masters 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 Catalentsponsored leadership programs such as NGGL GOLD LEAD Now GM Excellence and GROW) may be considered in place of external experience.
Preferred Skills & Background
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.
Why You Should Join Catalent
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.
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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Required Experience:
Manager
About Company
Providing CDMO services, delivery technologies and manufacturing solutions to develop pharmaceuticals, biologics and consumer health products.