Catalent Pharma Solutions Scientist, Analytical Method Development in St. Petersburg, Florida
Job Title: Scientist, Analytical Method Development
City: St. Petersburg
Support, develop and validate analytical test methods, evaluate and test raw materials, and test non-commercial materials to support product development.
Provide analytical services to manufacturing, process development, validation and new material qualifications.
Perform all of the foregoing in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and Quality departmental policies. Independently develop, validate, and routinely execute test methods in support of Drug Substances and Drug Products as required.
Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines.
Communicate results in written and oral presentations. Assist 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 to perform all work in a safe manner. Maintain proper records in accordance with all SOPs and policies.
Develop and validate instrumental methods on instruments including, but not limited to, High Performance Liquid Chromatography (HPLC), gas chromatography (GC), dissolution, in support of Drug Substances and Drug products. Analyze of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
Prepare reagents/standards/medias needed for analysis according to established methods. Safe handling of potent and teratogenic compounds.
Disposal of hazardous waste according to environmental regulations and company/ departmental procedures.
Tabulate and interpret results of analysis as recorded in notebooks, reports and logbooks. Self-schedule work assignments. Assure right-first-time execution of departmental methods and SOPs. Facilitate and support activities and services necessary to the routine operations of the department, as assigned.
Audit and verify results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
Write and review analytical methods, deviations, protocols, SOPs and any other technical document. Lead all analytical method transfer activities as required by their area.
Support Material Evaluation Process for new materials. Conduct and write laboratory investigations using the appropriate Root Cause Analysis tools.
Participate in inter-departmental task teams. Interface with peers in other departments, senior management, customers and regulatory agencies.
Provide support for ordering and maintaining inventory of laboratory materials and equipment.
Provide training for new or existing personnel. Identify and implement process improvements that will reduce cycle time to test and release products. Perform other miscellaneous duties as required.
Perform all of the foregoing using common pharmaceutical laboratory equipment including, but not limited to
H.P.L.C. and G.C. instrumentation
Wet chemistry techniques including titrations, extractions, digestions and preparations of test solutions
Chromatography Software e.g. Emplower-3, TotalChrom and ChemStation
EDUCATION AND EXPERIENCE REQUIREMENT: Requires a Bachelor’s degree in Pharmacy, Chemistry, Biology, Microbiology, or related sciences (as applicable) and 5 years of experience in job offered or 5 years of experience in the Related Occupation
Analytical Chemist or any other job title performing all listed job duties.
JOB TIME: Full Time
Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.
Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.
We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.
Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.
Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.
Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.
We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.
We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.
Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.