Catalent Pharma Solutions Quality Control Prinicipal Analyst in Winchester, Kentucky

Job Description

Principal Quality Control Analyst

Position Summary

The Principal Quality Control Analyst reports to the Quality Control Manager.

Come join an exciting and fast paced Quality Control Team at Catalent, Winchester, KY!

The Principal QC Analyst is responsible for providing technical expertise to the Quality Control function to support all scale up and commercial operations. The Principal QC Analyst is the mastery level of exceptional performing Senior QC Analysts. Principal QC Analysts deliver sustained contributions that result in new and/or improved processes and methodologies. Employees at this level are recognized as masters of analytical techniques and are points of contact for troubleshooting methodologies and instrumental problems. Generally they have developed into a “go to” analyst for a particular analytical technique. Individuals in this roll are very independent and self-motivated.

This analyst will be responsible for method and process development to support raw material and finished goods testing. He/She communicates and interacts with internal and external stakeholders, including regulatory bodies. Analysts at this level have demonstrated significant scientific and technical breadth to support analytical test methods in a pharmaceutical manufacturing facility. While this role does not have direct supervisory responsibilities, it is a key member of the QC Leadership Team and is expected to provide significant time and effort to coaching and developing the organization.

Catalent's Winchester location is the flagship US manufacturing location for large scale complex controlled release (CR) oral dose forms, with integrated analytical and development services. With 20 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry leading Glatt technology. This site offers newly installed Fluid Beds, expanded analytical labs, and an advanced open facility design that provides flexibility in supporting the requirements of any new customer program.

The Role

  • Ability to perform, technically evaluate and train others on analytical techniques including but not limited to: chromatographic techniques (HPLC, TLC and GC, etc.), in-process/finished product analysis (blend/content uniformity, dissolution, related substances, and potency, etc.) and raw material analysis (polarimetry, loss on drying, heavy metal content and viscosity, etc.). Communicates effectively and in a timely manner any issues and concerns, both timeline and operational related, to a QC Manager.

  • Uses experience and analytical chemistry knowledge to identify non-obvious technical connections between projects (past and present) and anticipates technical issues with current and new analytical methodologies.

  • Will play a critical role in providing day to day and year end performance feedback to analytical team. While this role will not be responsible from a formal reporting relationship perspective, it is expected that coaching, mentoring, teaching and technical development will be a core piece of responsibilities.

  • Makes timely decisions when faced with uncertainty.

  • Assists with special administration projects and other tasks as needed.

  • Reviews and signs off on analytical data and Certificates of Analysis.

The Candidate

  • Education combined with Work Experience

  • Bachelors Degree in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry or Biology) with 7 to 10 Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role

  • Masters Degree in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry or Biology) with 4 to 8 Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role

  • PhD in Chemistry (Preferred in Analytical Chemistry or Pharmaceutical Sciences) with 0 to 3 Years in a Quality, Laboratory or Clinical role (including time as a post doc)

  • Flexible to 2nd and 3rd Shifts Preferred

  • Exceptional laboratory knowledge and skill set with a demonstrated ability to understand, perform, and recognize problems with compendia and costumer supplied testing methods.

  • Mastery with analytical techniques as pertaining to a pharmaceutical manufacturing setting. Analytical mastery will be exhibited in chromatographic techniques (HPLC, TLC and GC, etc.), in-process/finished product analysis (blend/content uniformity, dissolution, related substances, and potency, etc.) and raw material analysis (Titration, polarimetry, loss on drying, heavy metal content and viscosity, etc.). This is achieved by recognition both inside and outside of quality assurance as a “go to” individual in all areas of testing

  • In-depth understanding of cGMP regulations and FDA/USP/EP/BP/ICH guidelines.

Position Benefits

  • Works cross-functionally and receives exposure to several departments

  • 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 develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493.

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.

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.