The Lead Scientist, QC is responsible for leading analytical testing, investigations, and key deliverables for the Quality Control (QC) group. The Lead Scientist, QC must demonstrate expert technical knowledge, trains new scientist on basic scientific/regulatory principles, possess initiative, and maintains a strong commitment to scientific excellence as well as a strong cGMP understanding and mindset to help drive compliance within the department. Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Shift: Friday-Monday 7am-6pm The role: * Maintains weekly schedule of incoming testing and balances priorities from routine manufacturing samples, stability samples and method transfer activities * Teaches others regarding his/her expertise, mentors and trains other members of the QC group in regards to day-to-day lab activities and team goals * Actively participates in training activities, managing individual training plan * Apply basic scientific and regulatory principles to solve operations, as well as routine tasks, in the QC department * Teaches others regarding his/her expertise, mentors and trains other members of the QC group in regard to day-to-day lab activities and team goals * Generate internal and external documents such as assay protocols, summary reports, client comment responses and SOPs * Supports release and stability testing for raw materials, components, standards, intermediate/finished products * Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC and Capillary Electrophoresis * Responsible for document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending The candidate: * Bachelor in a Life Sciences discipline with 6 - 8 years of experience working in a cGMP QC laboratory. * Masters' in a Life Sciences discipline with 4 - 6 years of experience working in a cGMP QC laboratory. * Ph.D. in a Life Sciences discipline with 2 - 4 years of experience working in a cGMP QC laboratory. * Experience with ELISA, ddPCR, qPCR, Empower 3 preferred but not required. * Knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology * Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in QC function with a strong familiarity of general GMP practices * Experience in writing SOPs Why you should join Catalent: * Competitive medical benefits and 401K * 152 hours PTO + 8 Paid Holidays * Dynamic, fast-paced work environment * Opportunity to work on Continuous Improvement Processes 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 Catalent Careers to explore career opportunities. 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, 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. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.