Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
Position Title: Group Leader, Characterization & Stability
Location: Madison, WI
The responsibility of the Group Leader, Characterization & Stability group would be inclusive of the following tasks:
Manage Madison Characterization & Stability Group (4 direct reports)
As a member of the Analytical Development Leadership Team, collaborate with clients to deliver world class formulation and characterization studies.
Develop and train junior Characterization & Stability scientists.
Enhance value of formulation, stability, and protein characterization studies performed in Madison to clients through high-value add activities
Education or Equivalent:
Experience in formulation and/or characterization and stability development for proteins, not limited to antibodies, required
Thorough understanding of the origins of protein stability, degradation, and folding and the various factors that can affect proteins during the pharmaceutical development process.
Expertise in the wide range of analytical techniques applied to biologic drugs formulation and stability studies; Mass Spectrometry expertise highly desired.
Experience in the statistical analysis and interpretation of formulation and stability data to drive decisions, preferred.
Excellent technical writing skills, and experience with authoring protocols, reports, and procedures for regulatory submissions
Experience mentoring and training junior staff
Ability to cross-train on techniques across multiple groups
Communicate effectively and follow detailed written and verbal instruction; ability to clearly communicate and provide mentorship to other groups and clients as necessary
Ability to peer review data to ensure data is well organized with complete documentation
Ability to interpret data, analyze trends and provide insight into potential issues and subsequent solutions
Proficient in the operations of a computer with MS-Excel, MS-Word as well as programs for multiple pieces of laboratory or manufacturing equipment
Positive attitude and ability to work well with others as a technical lead
Ability to write SOPs and reports independently
Ability to complete investigation, deviation, and change control forms independently
Ability to integrate timelines, devise batch records and meet milestones for successful project completion
Ability to troubleshoot and problem solve in order to initiate and execute/monitor corrective action
Ability to set deadlines and prioritize work for self, group members, and support groups/individuals involved
Ability to perform accountabilities and responsibilities independently and provide supervisor with updates as necessary
Ability to design protocols and establish project timelines with minimum Supervisor input
Proficient in operation and troubleshooting of a wide variety of analytical instrumentation and data systems
Monitors quality of analyst lab work within group and mentors analysts regarding scientific and regulatory requirements of projects
Ability to provide ideas for process improvements
Ability to work with a team of individuals to meet goals
Occasional bending, grasping, carrying, stooping, kneeling, crouching
Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds
Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure.
Collaborative and inclusive
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 www.catalent.com/careers to explore career opportunities.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.