Analytical Chemist III

Analytical Chemist III

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.

Catalent Pharma Solutions in Malver, PA is hiring an Analytical Chemist III. The Analytical Chemist III is responsible for the Analytical testing of client compounds following client guidelines, CMTI procedures, policies, and cGMPs to ensure timely flow and completion of in-process micronization and milling and external analytical testing

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This is a full-time role position: Monday-Friday -XX shift. Hourly, Onsite

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

The Role  

• Carry out all duties in line with the QA / cGMP / Safety standards at CMTI. Carry out the analytical testing activities of pharmaceutical actives and excipients according to client specific test methods, CMTI test methods, or USP tests. Verify cleaning of processing equipment through analytical testing procedures. Technical support and assistance in training of analytical chemist I & II (i.e. test methods, Documentation, etc)

• General housekeeping of the facility. Coordinate and communicate testing activities with clients as needed. Able to individually evaluate data and communicate information with internal and/or external stakeholders to drive on time results and release of products

• Continual development of Analytical techniques and associated activities. Carry out all duties safely, using the appropriate procedures and equipment as instructed. General housekeeping of the laboratory.

• Perform analytical testing on external sample submissions.  Such testing may include, but is not limited to: Particle size analysis, surface area analysis, HPLC analysis, DSC, TGA,  XRPD, compendial testing, etc. Support Management by communicating directly with clients regarding new projects, on-going projects, etc.

• Able to evaluate data and effectively communicate results and facilitate discussions with clients internally and externally to define solutions and strategies.  Able to drive internal projects and complete tasks on time within scope.Able to perform and author investigations including Out Of Specification (OOS), Deviations and Customer complaints as required. Evaluate quotations for clients and develop action plans for study implementation. Author, collaborate and/or review technical documents (SOP’s, test methods, protocols etc.) 

• Prepare written test reports summarizing all analytical results derived in support of CMTI Operations or external sample submissions. Conduct peer data review of raw data/documentation.

• Provide technical training and mentoring for colleagues. Provide analytical support to CMTI Operations group, with emphasis on in-process particle size analysis, ID testing, controlled supply testing, cleaning verification etc.  Communicate in-process testing results to Operations personnel in a timely manner.

• Document all testing, deviations, investigations etc. as per cGMP and CMTI guidelines. Perform routine maintenance and conduct performance verification testing on analytical equipment. Maintain a clean, safe working environment.  Responsibilities may include:  glassware cleaning, solvent/sample disposal etc.

• Attend technical, cGMP or safety training courses/seminars as appropriate. Support site QA actions and plans, including audit support and validation activities. Perform miscellaneous administrative tasks in support of daily laboratory operations.  Such tasks may include ordering supplies, conducting inventory, sample tracking/login etc.

• All other duties as assigned; 

The Candidate 

• Required a Bachelor’s Degree

• A minimum of three years of laboratory  experience highly desired

• Strongly prefer GMP experience

• Proficient