Catalent Pharma Solutions Senior Chemist in Woodstock, Illinois

Job Description

Position Summary

Catalent is looking to recruit a Senior Chemist to join a growing Quality department at our site in Woodstock, IL.

The Senior Chemist will be responsible for training chemists and entry-level chemists, performing Chemistry Documentation review, troubleshooting instrumentation, and supporting New Product Development (NPD) project activities.

Additionally, the Senior Chemist will audit and review analytical testing, reagent preparation, instrument calibration and validation testing performed in the Chemistry Laboratory; and lead the support for validation projects and coordinating method transfers from customers.

In concert with Catalent’s Patient First philosophy, this role is paramount to ensure the efficacy and quality of our manufacturing processes which will ultimately yield safe drug products for patients.

The Role

  • Perform validation protocols, method transfers, and write standard operating procedures for new equipment and/or processes

  • Coordinate testing with Validation and NPD to provide chemical testing support and personnel for testing

  • Respond to Customer and interdepartmental requests for information on raw materials and method transfer availability

  • Train chemists and entry-level chemists on analytical testing on raw materials, in-process bulk material, finished product, cleaning, customer, stability samples, and USP & EP Compendia methods

  • Review and approve Documentation for the release of product; review Standard Operating Procedure revisions and report forms to increase efficiency of chemists and maintain cGMP and GLP’s

  • Guide Chemistry Out of Specification (OOS) investigations and non-routine events; investigate for the root cause of the OOS and help to maintain a cGMP laboratory

  • Audit and review all laboratory and chemist procedures and work product including: In- process, cleaning samples, finished product, raw material and water testing; notebook, validation and expiration studies; reagent and standard preparation and instrument usage logs

The Candidate

  • Bachelor of Science in Chemistry preferred; other Scientific disciplines may be considered

  • 5+ years’ experience in a cGMP and/or pharmaceutical manufacturing environment

  • Subject Matter Expert level knowledge on HPLC instrumentation to include commissioning and decommissioning

  • Deep experience performing instrument qualification, validation, new product development, method transfers, and protocol writing; experience with URS (User Requirement Specifications) preferred

  • Proficient analytical data reviewer with strong technical writing skills

  • Proven leadership skills including demonstrated training/mentoring of junior chemists

Catalent’s standard leadership competencies that are used to interview and for Performance & Development

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits

  • Potential for career growth within an expanding Quality team

  • Defined career path and annual performance review & feedback process

  • Cross functional exposure to other areas of Quality and Production

  • Medical, Dental, Vision, and 401K are all offered from day one of employment

  • 19 days of paid time off annually + 7 paid holidays

About Catalent

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. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities.

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, protected veteran status, sexual orientation, or gender identity. 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.

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.

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.

Why Catalent?

  • 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.