Senior Scientist, Analytical Research & Development

Senior Scientist Analytical Research & Development

Position Summary

• Work Schedule: Standard Hours; Monday through Friday

• 100% on-site

Join Catalents flagship softgel development and manufacturing facility in North America located in St. Petersburg FL with a capacity of 18 billion capsules per year. This role offers competitive pay day-one benefits and career growth in a state-of-the-art turn-key facility.

The Senior Scientist Analytical Research & Development supports the development and validation of analytical test methods raw material evaluation and testing of non-commercial materials to advance product development manufacturing process validation and new material qualifications in accordance with regulatory and quality standards. At Catalent this role offers exceptional exposure to a diverse portfolio of molecules formulated into the softgel platform spanning womens health oncology prescription therapeutics and more providing hands-on experience from development through commercial validation. As part of a CDMO environment the position delivers broad cross-functional collaboration and the opportunity to build advanced analytical skill sets.

The Role

• Independently develop validate and routinely execute instrumental test methods in support of Drug Substances and Drug Products; analyze data document results in accordance with cGMP and internal guidelines and communicate findings through written and oral presentations.

• Serve as lead scientist for designated projects including direct client communications participation in project team meetings and teleconferences and support of new product development in collaboration with customers and suppliers.

• Perform analysis of finished products in-process materials raw materials fill moisture cleaning verification/validation samples and support the Material Evaluation Process for new materials according to assigned specifications methods and protocols.

• Write review and support analytical methods deviations protocols specifications SOPs and laboratory investigations using appropriate Root Cause Analysis tools; lead analytical method transfer activities as required.

• Ensure right-first-time execution of departmental methods and SOPs; audit and verify analytical results for accuracy and data integrity; maintain proper records in notebooks reports and logbooks in compliance with FDA EPA OSHA and company regulations.

• Safely handle potent and teratogenic compounds; prepare reagents standards and media; manage hazardous waste disposal; support ordering and maintenance of laboratory materials and equipment.

• Contribute to continuous improvement by training colleagues leading and coordinating personnel training participating in inter-departmental teams interfacing with management self-scheduling assignments and working flexible hours as required to support production and validation schedules.

• Other duties as assigned.

Qualifications

• Doctorate in scientific field with 3-years experience in lab 2 in GMP required OR

• Masters in scientific field with 5yrs experience in lab 3 in GMP required OR

• Bachelors in scientific field with 10-yrs experience in lab 8 in GMP required

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

• VISION: Ability to read written documents and computer monitors differentiate color and maintain 20/30 vision with or without corrective lenses; able to work extended or off-hours as required.

• Individual may be required to sit stand walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.

Why You Should Join Catalent

• Tuition reimbursement to support educational goals

• WellHub program to promote physical wellness & Access to Perkspot discounts from over 900 merchants

• 152 hours of PTO plus 8 paid holidays

• Medical dental and vision benefits effective day one

• Defined career path with annual performance reviews & strong potential for career growth within a mission-driven organization

• Inclusive culture with active Employee Resource Groups & Community engagement and green initiatives

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 . 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.

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