Group Leader, BioAnalytics-Commercial Testing

Group Leader, BioAnalytics-Commercial Testing

Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.  

Catalent’s Kansas City facility is home to our Clinical Delivery Services and Biologics Analytical Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Group Leader, BioAnalytics-Commercial Testing. A Group Leader in Commercial Testing is primarily responsible for managing a sub-team comprised of junior Scientists.  Their responsibilities will include serving as technical experts on projects, act as liaison between their team and various cross functional technical team, coaching and mentoring various Associates, HR activities (e.g., performance reviews, time entry approval, PTO approval, salary adjustments, etc.), supporting client audits/visits, and communicating with cross-functional teams on analytical activities for Biopharma product development under Good Manufacturing Practice (cGMP) regulatory guidance for Large Molecules/Biologics product development.

This is a full-time onsite, salaried position.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role: 

• Serve as technical expert on the following techniques as appropriate: Compendial assays (i.e. appearance, pH, moisture, Osmolality, HIAC, CCI). Capillary and Gel Electrophoresis (i.e. CE-SDS, SDS-PAGE, icIEF, IEF, western blot), Chromatography such as HPLC/UPLC (i.e. SEC, IEX, RP, HIC, peptide map, glycan analysis), UV-VIS, In vitro cell based potency methods, ELISA assays, quantitative and potency (i.e. fluorescence, luminescence, colorimetric, MSD) and Flow cytometry
• Responsible for method transfers, method verifications, qualifications and validations, release testing, stability study and adhoc sample testing in Commercial Testing
• Plan, prioritize, organize, and execute the conduct of analytical work within the Commercial Testing Laboratory in accordance with the requirements of the client contract and/or technical agreement; support projects and maintain project timelines and budget
• Support and lead computer system validation activities, as required
• Assure the integrity and quality of analytical data produced by ensuring staff are adhering to all relevant in-house and client Standard Operating Procedures (SOPs) and methodologies and following the requirements of GMP
• Perform checking & verifying of peers’ analytical data in accordance with in-house SOPs; ensure that safe working practices are adopted in the laboratory and comply with in-house SOPs and other safety legislation
• Ensure that performance reviews and other HR activities (e.g., time entry approval, PTO approval, salary adjustments, etc.), are carried out in accordance with company policy
• All other duties as assigned

The Candidate:  

• Bachelor’s degree is required with at least four years of relevant experience defined below; we will also accept a Master’s degree with two years or a PhD with one year of experience
• Must have hands-on and theoretical knowledge of Compendial assays (i.e. appearance, pH, moisture, Osmolality, HIAC, CCI); Capillary and Gel Electrophoresis (i.e. CE-SDS, SDS-PAGE, icIEF, IEF, western blot); Chromatography such as HPLC/UPLC (i.e. SEC, IEX, RP, HIC, peptide map, glycan analysis); UV-VIS, In vitro cell based potency methods, ELISA assays, quantitative and potency (i.e. fluorescence, lumin