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Senior Scientist, Analytical Research & Development

Position Summary

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.

St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation.

The Senior Scientist, Analytical Research & Development will independently develop, validate, and routinely execute test methods in support of Drug Substances and Drug Products as required. The Senior Scientist, AR&D analyzes data, document results, maintain laboratory notebook according to cGMP and Internal guidelines. Communicate results in written and oral presentations. Help in writing Procedures, Specifications and Test Methods. Keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group. Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies.

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.

The Role

• Provides project support for new product development which requires a close working relationship directly with Customers as well as suppliers.

• Lead all analytical method transfer activities as required by their area.

• Ability to independently develop and validate instrumental methods in support of Drug Substances and Drug products.

• Expected to be the lead scientist for designated projects, to include direct client communications and attendance at project team meetings and teleconferences.

• Leads and coordinates training for new or existing personnel as assigned by laboratory management.

• Ability to make autonomous decisions regarding day-to-day activities.

• Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.

• Tabulation and interpretation of results of analysis as recorded in notebooks, reports and logbooks.

• Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data. Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical document. Conducts and writes laboratory investigations using the appropriate Root Cause Analysis tools.

• Other duties as assigned.

The Candidate

• Doctorate in scientific field with 3+years’ experience in lab, 2 in GMP required OR

• MS in scientific field with 5+yrs experience in lab, 3 in GMP required OR

• BS in scientific field with 10+ yrs experience in lab, 8 in GMP required.

• 5+ years’ experience with identification or separation techniques such as HPLC, UPLC, GC, MS, NMR and experience with method development and or validation.

• Must possess good interpersonal skills.

• Ability to effectively communicate with co-workers.

• Good organizational skills required.

• Experience with drug development and regulatory requirements for submissions

• Experience with common pharmaceutical laboratory equipment including, but not limited to, U.V. spectroscopy or and AA instrumentation.

• Expertise in wet chemistry techniques such as titrations, extractions, digestions, and preparations of test solutions.

• Individual may be required to sit, stand, walk regularly and occasionally lift 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 circle.

Why You Should Join Catalent

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• WellHub program to promote overall physical wellness.

• 152 hours of PTO + 8 paid holidays.

• Medical, dental and vision benefits effective day one of employment.

• Defined career path and annual performance review and feedback process.

• Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.

• Dynamic, fast-paced work environment.

• Positive working environment focusing on continually improving processes to remain innovative.

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of 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.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .