Group Leader, Molecular & Cellular Biology

Group Leader, Molecular & Cellular Biology

Position Summary:

• Work Schedule: Monday – Friday, 8AM – 4:30PM
• 100% onsite (Kansas City)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our large molecule analytical team has over 25 years of experience providing broad-based and orthogonal analytical CMC services for stand-alone and integrated biologics projects.  We provide support for drug substance, drug product, and intermediates for both innovator and biosimilar/biobetter products

We are hiring Group Leader, Molecular & Cellular Biology who 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.

The Role: 

• Serve as technical expert on the following techniques as appropriate: Mammalian cell culture, Sterile technique, In vitro cell based assays (e.g., reporter gene bioassay, cell titer glo proliferation bioassay), ELISA assays, quantitative and potency (fluorescence, luminescence, colorimetric, MSD), Molecular biology (e.g., qPCR, PCR), Kinetic binding assessment (e.g., BLI or SPR), Flow cytometry 
• Responsible for method development, method evaluation/feasibility, method transfers, method verifications, qualifications and validations, stability study and adhoc sample testing in Molecular and Cellular Biology
• Plan, prioritize, organize, and execute the conduct of analytical work within the Molecular and Cellular Biology Laboratory in accordance with the requirements of the client contract and/or technical agreement
• Support Project Technical Lead to 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 in-house and client 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 
• Support in production of costing and timelines for client projects. Communicate effectively with clients, auditors, peers, and Directors to facilitate the smooth conduct of project activities. Establish and maintain technical communications with other groups and clients, as needed. Support to track business unit revenue targets 
• 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. Co-ordinate 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:  

• Bachelor’s Degree minimum is required plus a minimum of four (4) years of relevant experience defined below. We will also accept a Master’s Degree with two (2) years or a PhD with one (1) year of experience
• Preferred hands-on and theoretical knowledge of Mammalian cell culture, Sterile technique, In vitro cell based assays (e.g., reporter gene bioassay, cell titer glo proliferation bioassay), ELISA assays, quantitative and potency (fluorescence, luminescence, colorimetric, MSD), Molecular biology (e.g., qPCR, PCR), Kinetic binding assessment (e.g., BLI or SPR), Flow cytometry
• Knowledge of the principles, theories, and concepts applicable to a wide range of work in a discipline (e.g., Biology, Chemistry, Biochemistry) and broad knowledge of principles and concepts in other disciplines
• In-depth knowledge in instrumentation, theory, data interpretation and applications in at least one technical area. Can assess new technologies and their impact on Catalent offerings. Knowledgeable in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones
• Ability to effectively communicate complex technical information to non-technical audiences and able to lead difficult discussions with customers and drive an acceptable resolution
• Highly preferred to have project management and people management skills
• 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
• Physical requirements: On an average 8-hour 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, fast-paced 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 7,000 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 DisabilityAccommodations@catalent.com. 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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