Stability and Cleaning Validation Team Manager

Job content

Position Overview

Job Description

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

An exciting opportunity has arisen for an experienced Manager to join the Stability and Cleaning Validation Team at our Swindon facility. Swindon facility houses our Zydis® fast dissolving tablet development and manufacturing operation as well as a CMC pharmaceutical analytical lab services unit that offers ASAP stability. Reporting QC Chemistry Manager, the successful candidate will be responsible for managing Stability and CV activities for the site. The Stability and Cleaning Validation Team Manager will be expected to have an oversight of the regulatory considerations of stability and cleaning validation activities.

The successful candidate will be responsible for tracking, planning, executing documenting and reporting of stability and CV activities. You will lead a team of 6-8 direct reports which will be made up of scientists, Co-ordinators, technicians, who will manage all aspects of the stability and cleaning validation operations and ensuring compliance with internal procedures, industry regulations, customer expectations and regulatory guidelines (ICH).

Responsibilities

• Have extensive knowledge of the following laboratory equipment: Balances, pH meter, UV, Karl Fisher, FT-IR, TLC, Dissolution, HPLC, Coulometric Karl Fisher, HPTLC, NIR, Raman, including trouble shooting.
• Write or check a stability report and an Analytical Summary Report. based on the protocol and test results generated.
• Have extensive knowledge of the following Quality system:
  
  • LIMS; Entering and checking of results, receiving of batches, Stability study protocol builds and stage approval.
  • Qumas; printing documents and creation of complex CR’s.
  • Trackwise; writing of complex OOS/ATR’s or method deviation reports, including the recommendation of effective CAPA’s. or similar Quality management and documentation systems

• Perform batch disposition activities for finished drug products and/or raw materials.
• Able to effectively communicate with other departments and external customers.
• Manage priorities and expectations of self and the team effectively using available resource to deliver timely results.
• Identify correct specifications and methods for testing, including stability and validation protocols.
• Maintain compliance with GMP and other analytical based regulatory requirements, taking a Page 2 of 2leading approach to audit preparations.
  
  

The Candidate

Essential

• A degree in a science based subject
• Knowledge of GMP regulations
• Builds and maintains employer and employee duty of care in relation to EH&S.
• Coaches and mentors individual team members with a view to long term succession planning.
  

Desirable

• A degree in a pharmaceutical sciences
• Experience of regulatory and customer audits
  

Catalent’s leadership competencies 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
  

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.

personal initiative. dynamic pace. meaningful work.
Visit www.catalent.com/careers to explore career opportunities.

C atalent 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, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local 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.