|at ( view profile)|
|Date Posted||November 15, 2019|
|Address||726 Heartland Trail|
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: Supervisor, Formulation and Characterization Group
Location: Madison, WI
The responsibility of the Formulation & Characterization Group Lead would be inclusive of the following tasks:
• Manage Madison Formulation & Characterization 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 formulation and characterization scientists.
• Enhance value of formulation, stability, and characterization studies performed in Madison to clients through high-value add activities
Education or Equivalent:
- Ph.D. in Chemistry or related field with at least 5 years of industry experience
- MS in Chemistry, or related field with at least 7 years of industry laboratory experience
- B.S/B.A. in Chemistry, or related field with at least 7-10 years experience in a laboratory environment
- 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 formulation and stability studies; Mass Spectrometry expertise desired.
- Experience in formulation development for proteins, not limited to antibodies, highly preferred
- Experience in both drug substance and drug product development.
- Experience in the statistical analysis and interpretation of formulation and stability data to drive decisions. Proficiency in JMP and/or R 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
- Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing,
- 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.
- Performance driven
- Customer focused
- Collaborative and inclusive
- Safety focused