Group Leader, BioAnalytics-Commercial Testing

Group Leader BioAnalyticsCommercial 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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.

Catalents 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 commercialscale manufacture. The Kansas City facility is a CenterofExcellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for standalone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City MO is hiring a Group Leader BioAnalyticsCommercial Testing. A Group Leader in Commercial Testing is primarily responsible for managing a subteam 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 crossfunctional teams on analytical activities for Biopharma product development under Good Manufacturing Practice (cGMP) regulatory guidance for Large Molecules/Biologics product development.

This is a fulltime salaried position: Monday Friday on 1st shift with core business hours between 8am4pm.

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. CESDS SDSPAGE icIEF IEF western blot). Chromatography such as HPLC/UPLC (i.e. SEC IEX RP HIC peptide map glycan analysis). UVVIS 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. Ensure various instruments/equipment in the group are in compliant status. Ensure cGMP practices are implemented and followed by the group and self
• Assure the integrity and quality of analytical data produced by ensuring staff are adhering to all relevant inhouse and client Standard Operating Procedures (SOPs) and methodologies and following the requirements of GMP
• Perform checking & verifying of peers analytical data in accordance with inhouse SOPs. Ensure that safe working practices are adopted in the laboratory and comply with inhouse 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. Coordinate training needs of subordinates through discussion and with reference to the core competencies. Maintain engagement of the team members and provide a learning and growth culture
• Support marketing and business development activities as needed. Maintain awareness of modern techniques and their application to biopharmaceutical sciences. Manage laboratory teams consisting of other scientists. Identify and implement new technologies with understanding of their impact on Catalent offerings
• All other duties as assigned

The Candidate:

• Bachelors degree minimum is required plus a minimum of four years of relevant experience defined below. We will also accept a Masters degree with two years or a PhD with one year of experience
• Must have handson and theoretical knowledge of Compendial assays (i.e. appearance pH moisture Osmolality HIAC CCI). Capillary and Gel Electrophoresis (i.e. CESDS SDSPAGE icIEF IEF western blot). Chromatography such as HPLC/UPLC (i.e. SEC IEX RP HIC peptide map glycan analysis). UVVIS In vitro cell based potency methods ELISA assays quantitative and potency (i.e. fluorescence luminescence colorimetric MSD) and Flow cytometry
• Must be knowledgeable in most aspects of drug development and lifecycle support and able to develop useful strategies and tactics to meet regulatory milestones
• Must have the ability to communicate complex technical information to nontechnical audiences and showcase good written and verbal communication
• Must have a general Quality Assurance knowledge and provide reliable/defendable interpretations of regulatory guidance
• Highly preferred to have project management and people management skills
• Physical requirements: On an average 8hour day this position requires the ability to walk sit and stand use hands to handle or feel reach with hands and arms at or above shoulder height and below waist height climb or balance stoop kneel crouch or crawl; talk and hear smell and lift up to 40 pounds. Specific vision requirements including reading of written documents visual inspection of materials and use of computer monitor screen frequently

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 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic fastpaced work environment
• Community engagement and green initiatives
• Generous 401K match
• Company match on donations to organizations
• Medical dental and vision benefits effective day one of employment
• Tuition Reimbursement Let us help you finish your degree or start a new degree!
• WellHub program to promote overall physical wellness
• Perkspot offers exclusive or private discounts from approximately 900 merchants in a wide array of categories

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

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.