Group Leader, Molecular & Cellular Biology
Catalent Pharma Solutions, Kansas City, MO, United States
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.
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 assays (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. 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
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, ELISA assays, quantitative and potency assays, 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.
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 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, 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 to the application or hiring process.
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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.
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 assays (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. 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
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, ELISA assays, quantitative and potency assays, 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.
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 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, 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 to the application or hiring process.
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