Position Title: Scientist I, Analytical Research & Development

City:                                         St. Petersburg

State:                                       FL

JOB DESCRIPTION:

• Assist with Development and Validation with some supervision.  Run routine test methods in support of drug substance and drug product sample testing as required.  Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines. Communicate results in written and oral presentations. Perform critical data review for method transfers and generation of stability reports to support regulatory filings.  Assist with data generation or compilation for regulatory inquiries, customer request and investigations.   Assist 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.
• Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
• Preparation of reagents/standards/medias needed for analysis according to methods.
• Safe handling of potent and teratogenic compounds.
• Disposal of hazardous waste according to environmental regulations and company procedures.
• Tabulation/interpretation of results as recorded in notebooks, reports and logbooks.
• Assures right-first-time execution of departmental methods and SOPs.
• Supports activities and services necessary to the routine operations of the department, as assigned
• 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.
• Assist with writing and reviewing analytical methods, protocols and SOPs.
• Supports Material Evaluation Process for new materials if required.
• Participates in inter-departmental task teams.
• Provides training for new or existing personnel.
• Identifies and implements process improvements that will reduce cycle time to test and release products.
• Performs other miscellaneous duties as required.
• Works flexible hours including weekends and evenings to accommodate the production / validation schedule

EDUCATION AND EXPERIENCE:

• Bachelor’s degree (BS) in a scientific field with 5 plus years’ experience in lab, 3 in GMP or
• Master’s degree (MS) in a scientific field with 3 plus years’ experience in GMP lab or
• Doctorate in scientific field with 1 plus years’ experience in lab
• Must possess good interpersonal skills
• Familiar with drug development and regulatory requirements for submissions
• Experience with common pharmaceutical laboratory techniques such as:   ―UV/VIS, IR and AA Spectroscopy―HPLC, UHPLC and GC separations―Dissolution, Rupture and Disintegration testing
• Expertise in wet chemistry techniques such as titrations, extractions and digestions.  
• Knowledge of the following: ―Safety and hazardous waste requirements―Data acquisition applications and databases―cGMP standards.
• Demonstrated history of method validation and stability testing.
• Demonstrated critical thinking ability and experience in laboratory investigations activities.
• Knowledge of various software packages common to analytical testing
• Ability to work effectively under pressure to meet deadlines.
• 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 circles.

JOB TIME:                                Full Time

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. 

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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.