Location: Morris Plains, NJ #LI-Onsite
About this role:
The Scientist, QC Microbiology, under general direction will direct and assist in functions supporting QC Microbiology.
Key Responsibilities:
• Perform Micro/EM testing such as, but not limited to, environmental monitoring, Gram stain, sterility, endotoxin, and mycoplasma.
• Perform all testing and activities compliantly following appropriate SOPs and Work Procedures.
• Perform logbook reviews and monthly laboratory cleaning.
• Maintain controls and reference materials to support testing.
• Enter/review data in LIMS, and review QC documents to ensure completeness, accuracy, consistency and clarity.
• Generate and analyze trend reports, and review reports that are generated and makes conclusions as to any action required based on the data.
• Maintain the gowning qualification program, and train lab personnel.
• Identify and execute process improvements, and lead and/or participate in investigations/CAPAs.
• Support 5S and Lean Lab projects.
• Interface with QA and regulatory agencies during audits.Minimum requirements
Essential Requirements
• BS, MS or advanced degree in Biology, Chemistry, Biochemistry, Microbiology or other related science.
Experience:
• 3-8 years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, cell and gene therapy, or medical device industry.
• Working knowledge of aseptic manufacturing, cGMPs, GLPs and applicable compendial and regulatory guidelines (e.g. FDA, EP, JP)
• Thorough knowledge of microbiological test methods and environmental monitoring programs.
• Experience with LIMS.
• Strong written and verbal communication skills.
• Detail-oriented with expertise in problem solving and solid decision making abilities.
Strong interpersonal skills.
The pay range for this position at commencement of employment is expected to be between $88,000.00 and $132,000.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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