Associate Scientist II

Organization
Catalent Pharma Solutions
Job Location
St. Petersburg, FL
Job Description

About Catalent 
 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 globally. 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 around the world. 
The Quality Control laboratory supports testing and release of raw materials, intermediate and finished products, and all critical systems supporting manufacturing operations such as purified and potable water, compressed gases, captive zone environmental analysis, as well as cleaning and process validation support. The department provides analytical services to manufacturing, Technical Services, Validation and new material qualifications. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburg's Quality departmental policies. 
Associate Scientist must independently test, develop and implement assays useful for the identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products. 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. 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. 
1. 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. 
2. Cultivate and identify bacteria or other microorganisms isolated on selective and non-selective media. 
3. Maintains cultures according to ATCC and departmental Standard Operating Procedures. 
4. Performs identification of microorganisms using techniques such as API, Gram Stain, etc. 
5. Prepares reagents, standards, Medias, etc. needed for analysis. 
6. May be required to work with potent and teratogenic compounds. 
7. Capable of working under moderate supervision. 
8. Responsible for login of samples (routine and non-routine) into GLIMS database and logbooks 
9. Interprets and tabulates results of analysis. Records the results in approved notebooks, reports and logbooks. 
10. Required to perform basic statistics to support analytical testing. 
11. Helps receive, label and store receipts of solvents and analytical reagents. 
12. Logs results into GLIMS database 
13. Verifies co-workers calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data. 
14. Shares responsibility for the routine calibration of analytical equipment such as, but not limited to balances, pH meters, KF analyzers, etc. 
15. May order supplies as needed 
16. Disposes of hazardous waste according to environmental regulations and company/departmental procedures. 
17. Files and maintains laboratory records following Good Manufacturing Practices and as directed through applicable SOPs. 
18. May provide training to new or existing personnel 
19. Helps maintain inventory of glassware, chemicals and materials needed for chemical analysis 
20. Required to maintain and clean laboratory instruments and equipment 
21. Required to read and execute departmental methods and SOPs. 
22. Required to assist in writing, reviewing, or revising procedures and/or laboratory investigations 
23. May be required to clean glassware used to perform chemical and/or microbiological analysis. 
24. Perform other laboratory related miscellaneous duties as required 
25. Required to work shifts in support of the manufacturing process that may include, weekends and holidays. The work hours may change depending on departmental needs. 
IV.  Knowledge Requirements:



Requirements: 

Education or Equivalent: 
Requires BA or BS with college course work in related sciences. At least (3) years experience in an analytical laboratory. Must possess good interpersonal skills. Ability to effectively communicate with co-workers. Good organizational skills required. 
Knowledge/Skills Requirements: 
1. Experience with U.V. spectroscopy 
2. Experience with IR and AA instrumentation 
3. H.P.L.C. and G.C. instrumentation experience 
4. Autoclave 
5. Vitek 
6. Experience in dissolution testing 
7. Expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions. 
8. Knowledge of safety and hazardous waste requirements 
9. Knowledge of data acquisition applications and databases 
10. Experience in conducting and writing laboratory investigations 
About Catalent 
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 globally. 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 around the world. 
Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world. 
Our VISION is to be the worlds most trusted, reliable and innovative drug development and delivery partner by upholding the highest industry standards and exceeding customer expectations while driving strong, sustained growth for the company. 
Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives. 
OUR VALUES are at the foundation of everything we do: 
•          Patient First:  We put patients at the center of our work to ensure the safety, reliable supply and optimal performance of our products 
•          Customer Dedication: We strive to exceed our customers expectations every day 
•          People: We are committed to the growth, development and engagement of our people 
•          Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes 
•          Integrity: We demonstrate respect, accountability and honesty in every interaction 
•          Excellence: We have a passion for excellence in everything we do. 
Catalent. More products. Better treatments. Reliably supplied. 

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