The Lead Scientist role is critical to the Microbiology group and the incumbent will act as a primary Project Lead interfacing with customers, writing protocols and communicating with the Group Leader to ensure incoming projects are ready to execute.
As a member of the microbiology team, you will utilize your expertise to support method development, method suitability and testing in support of the pharmaceutical industry. Your efforts will focus on delivering high quality technical support to the development and execution of microbiological methods such as Microbial Enumeration, Sterility in a barrier isolator, Endotoxin, Antimicrobial Effectiveness, Container Closure Integrity and non-routine microbiological assays. You will serve as a mentor to junior analysts contributing to their microbiology training and development. You will apply your experience and expertise to author microbiology Standard Operating Procedures and analytical methods. As a scientist and leader in our organization you will be a key component of the engine that powers our operation, applying your microbiological expertise.
A high level of expertise with Microbial Enumeration, Endotoxin and Sterility testing in a barrier isolator is required. Experience working in a highly GMP-regulated environment is required. Additional experience with endotoxin, AET, TOC, CCI, authoring SOP's, laboratory investigations and training/mentoring is also preferred.
The Role (daily responsibilities)
- Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics. Sample types include USP, JP, and EP release testing and stability testing.
- Techniques include but not limited to: sterility, bioburden and microbial limits testing, or endotoxin testing.
- Perform method validation or transfer activities.
- Authors and may approve technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures
- Trains, coaches or mentors others on technical, personal development or business issues
- Responsible as Project Technical Lead with responsibility for project outcome and customer interaction
The Candidate (requirements)
- Degree in microbiology or biology or closely related physical science.
- Bachelor's degree with 9 - 10 years related experience, equivalent education, experience and training; Master's degree with 6 - 8 years related experience, equivalent education, experience and training; OR Doctorate Degree with 2 – 4 years related experience.
- Industry experience as a microbiologist
- AET, Kinetic/Gel Endotoxin, MET, Sterility testing experience
- Strong project management skills
Potential for career growth within an expanding team
Defined career path and annual performance review and feedback process
Medical, Dental, Vision and 401K are all offered from Day One of employment
19 days of paid time off annually + 7 paid holidays
About Catalent (STANDARD – DO NOT EDIT!)
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.
Catalent. More products. Better treatments. Reliably supplied. ™
Visit www.catalent.com/careers to explore career opportunities, or contact us at
+1 877 503 9493.
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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.