Catalent Pharma Solutions Quality Control Supervisor - 2nd Shift in Winchester, Kentucky

Job Description

Quality Control Supervisor – 2nd Shift

The Quality Control Supervisor Reports to the Quality Control Manager

Position Summary

Come join a dynamic and rewarding Quality Control Group. The Quality Control Supervisor is responsible for supervising QC, Senior QC, and Principal QC Analysts and overseeing scheduling of all analytical functions to support manufacturing and quality agreement necessities for all scale up and commercial operations.

Analysts at this level have demonstrated significant scientific and technical breadth to support analytical test methods in a pharmaceutical manufacturing facility. They also have demonstrated the ability and desire supervise, train, coach and mentor other analysts. Individuals in this roll are very independent, well organized, and self-motivated and are expected to communicate effectively. Interaction with internal and external stakeholders and regulatory bodies will be commonplace.

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

  • Supervise and provide day to day direction and support for (three to ten) analysts, potentially across multiple shifts and functions (raw materials, in-process, finished goods, cleaning validations, or “project”). Will be responsible for annual performance reviews, performance feedback, coaching and any formal “personnel” related items.

  • Exhibit analytical mastery across all testing methodologies in the QC laboratory pertaining to pharmaceutical manufacturing and serve as mentors and coaches for individuals within the QC organization. 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 (flame atomic absorption, polarimetry, loss on drying, heavy metal content and viscosity, etc.). This is achieved by recognition both inside and outside of Quality as a “go to” individual in all areas of testing.

  • Oversee “out of specification” and aberrant lab investigations.

  • Review and sign off on analytical data and Certificates of Analysis.

  • Coordinate scheduling of laboratory work and procedures to support manufacturing needs, i.e., raw materials, in-process, finished goods, cleaning validation, in process and stability testing along with management directed work. Effectively communicate work responsibilities and timelines to Associate, QC, and Senior QC Analysts.

  • Communicate effectively and in a timely manner any issues and concerns (timeline, personnel, and operational related) to a QC Manager and effectively motivate analysts and keep work flow on track to meet or exceed customer’s timelines.

  • Able to seamlessly move into role of QC Manager on a periodic basis in the absence of formal management staff or as part of a special project.

  • Write test methods and specification sheets.

The Candidate

  • Bachelors Degree in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry or Biology) AND 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) AND 4 to 8 Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role; PhD in Chemistry (Preferred in Analytical Chemistry or Pharmaceutical Sciences) AND 0 to 3 Years in a Quality, Laboratory or Clinical role (including time as a post doc)

  • Prior supervisory experience is preferred, but not required.

  • Ability to work well under pressure with no supervision or direction and maintain efficiency and meet or exceed customer’s deadlines.

  • 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 (flame atomic absorption, 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/etc. guidelines.

Position Benefits

  • Works cross-functionally and receives exposure to several departments

  • Potential for career growth within an expanding QC team as well as other areas

  • Salary commensurate for working 2nd Shift

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

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

Leadership Competencies for Performance and Development

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

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.