Associate Scientist II, Quality Control

Associate Scientist II Quality Control

Position Summary

Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full life-cycle supply. With time-tested experience in development sciences delivery technologies and multi-modality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

Catalent is committed to a Patient First culture through excellence in quality andcompliance and to the safety of every patient consumer and Catalent employee.

The Associate Scientist II Quality Control will independently test develop and implement assays useful for the identification and characterization of Raw Materials pre-capsulation Stability and Finished addition this role will Analyze 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. The Associate Scientist II Quality Control will 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 and maintain proper records in accordance with all SOPs and policies.

This position is 100% on-site at the St. Petersburg site.

Shift : Monday - Friday 1 pm - 9 : 30 pm

The Role

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.

Performs analysis of finished products validation samples in-process materials and raw materials moisture testing Gas Water and manufacturing environmental sampling and testing according to the effective

Specifications protocols Methods and Compendial monograms.

Cultivate and identify bacteria or other microorganisms isolated on selective and non-selective media.

Maintains cultures according to ATCC and departmental Standard Operating Procedures.

Performs identification of microorganisms using techniques such as API Gram Stain etc.

Prepares reagents standards Medias etc. needed for analysis.

Interprets and tabulates results of analysis. Records the results in approved notebooks reports and logbooks.

Other duties as assigned.

The Candidate

Requires BS or BA with college course work in related sciences analytical laboratory experience preferred but not required. Must possess good interpersonal skills. Ability to effectively communicate with co-workers. Good organizational skills required.

Experience with common pharmaceutical laboratory equipment including but not limited to : experience with U.V. spectroscopy experience with IR and AA instrumentation H.P.L.C. and G.C. instrumentation experience Autoclave Vitek and dissolution testing.

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

Knowledge of safety and hazardous waste requirements

Knowledge of data acquisition applications and databases

Experience in conducting and writing laboratory investigations

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 Catalents in-house screening the acceptable score is to identify at least 4 of 6 numbers in the circles.

Why You Should Join Catalent

Competitive medical benefits and 401K

152 hours of PTO 8 Paid Holidays

Dynamic fast-paced work environment

Opportunity to work on Continuous Improvement Processes

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.

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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Required Experience :

IC

Key Skills

Laboratory Experience,ELISA,Immunoassays,Transfection,Mammalian Cell Culture,Suspension Experience,Biochemistry,Assays,cGMP,Cell Culture,Molecular Biology,Flow Cytometry

Employment Type : Full-Time

Experience : years

Vacancy : 1