Group Leader, Molecular & Cellular Biology

Catalent•Kansas City, MO

1d•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

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
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

Responsibilities

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

Benefits

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.