Senior Scientist, Analytical Research & DevelopmentSt. Petersburg in the primary softgel development and manufacturing facility in North America. The site has the capability to develop lipid formulations in a dedicated pilot plant which supports rapid transition from laboratory scale to clinical supply. Liquid in bottle, as well as Liquid fill Hard shell capabilities at the facility provide diversification and offerings that increase the speed to clinic. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges. Our analytical laboratory provides a full service offering from development of analytical methods to routine QC testing, supporting commercial and development stability studies. With capacity to generate over 18 billion softgels per year and servicing over 100 markets globally, the St. Petersburg site can handle any Over the Counter (OTC), Prescription (Rx), Medical Device, Controlled Substance, or Dietary Supplement manufacturing needs. The facility also contains a segregated hormone manufacturing area that meets current regulatory requirements. In addition to the manufacturing of traditional animal based gelatin softgels, St. Petersburg site manufactures products in non-gelatin based OptiShell4 and Vegicaps4 to expand the range of molecules that can be encapsulated.
Position SummaryWe have an opportunity for a Senior Scientist, Analytical Research & Development to join our team. This role involves developing, validating, and executing test methods for Drug Substances and Drug Products. The position includes analyzing data, documenting results, maintaining laboratory records, and communicating findings through written and oral presentations. The Senior Scientist will also contribute to writing procedures, specifications, and test methods, while supporting continuous improvement and compliance with all regulatory and safety standards.
Shift: Monday - Friday, 8:00am to 5:00pm
Location: St. Petersburg, FL
100% Onsite
The Role- Independently develop and validate instrumental methods in support of Drug Substances and Drug Products
- Serve as lead scientist for designated projects, including direct client communications and participation in project meetings and teleconferences
- Analyze finished products, in-process materials, raw materials according to assigned specifications and protocols
- Prepare reagents, standards, and media needed for analysis according to established methods
- Safely handle potent and teratogenic compounds; Dispose of hazardous waste according to environmental regulations and company procedures
- Write and review analytical methods, deviations, protocols, SOPs, and other technical documents; Tabulate and interpret analytical results in notebooks, reports, and logbooks
- Lead analytical method transfer activities as required
- Interfaces with peers in other departments and management
- All other duties as assigned
The CandidateMinimum Requirements- Requires Ph.D. in a scientific field with 3 years of laboratory experience and 2 years in Good Manufacturing Practice OR Master of Science in a scientific field with 5+ years of laboratory experience and 3 years in Good Manufacturing Practice OR Bachelor of Science in a scientific field with 10 years of laboratory experience and 8 years in Good Manufacturing Practice
- Minimum of 5 years of experience with identification or separation techniques such as High-Performance Liquid Chromatography, Ultra-Performance Liquid Chromatography, Gas Chromatography, and Mass Spectrometry, including method development and validation
- Experience with drug development and regulatory requirements for submissions; Experience using data acquisition systems such as Chemstation, Empower, and Totalchrom
- Expertise in wet chemistry techniques such as titrations, extractions, digestions, and preparation of test solutions
- Familiarity with International Council for Harmonisation and United States Pharmacopeia/European Pharmacopeia method validation requirements
- Individual may be required to sit, stand, walk regularly, and occasionally lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance
- Vision requirements include ability to differentiate color (pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent's in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
Preferred Skills & Background- Experience in peptides handling and method development is preferred.
Why You Should Join Catalent- Positive and fast-paced working environment focusing on continual improvement and innovation
- Competitive Paid Time Off plus 8 paid holidays
- Medical, dental, and vision benefits effective from day one of employment
- Tuition Reimbursement to support educational advancement
- Employee Resource Groups promoting Diversity and Inclusion
- Environmentally friendly initiatives including community engagement and beach clean-ups
- Defined career path with annual performance reviews and growth opportunities
- WellHub program promoting physical and mental wellness
- Perkspot offering exclusive discounts from over 900 merchants across various categories
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.
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