Catalent’s 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. We are currently recruiting for a Principle Analytical development Scientist to join our busy Swindon site. The Principle Analytical Development Scientist will work within the Analytical Support team in maintaining the day-to-day effective operation and compliance within the chemistry and microbiology laboratories. The role: Conduct all activities in accordance with site and corporate standard operating procedures (SOP’s) and cGMP. To act as Subject Matter Expert (SME) across all main areas of responsibility for Analytical Support including but not limited to: Maintenance & Calibration Management. Service Provider Management. Equipment user administration. Work as a technical expert and coach across laboratory applications, offering support & guidance for new equipment and during investigations and instrument troubleshooting. Own Trackwise Deviations, Events, Investigations and Change Controls, ensuring timely completion. Manage the process for completion of ‘Reviews’ including but not limited to Annual, Pharmacopeia and other ‘Reviews’ as required. Provide an administration management role for computer-based laboratory equipment, including user admin, data Backup and any other compliance supporting requirements. Use technical expertise and knowledge to provide support, guidance and troubleshooting across laboratory instrumentation & associated computer systems for the QC and Analytical Development laboratories. Influence and implement best practices with respect to laboratory equipment related procedures, using laboratory experience and technical knowledge within the QC and Analytical Development laboratories. To keep abreast of regulatory and corporate trends impacting the laboratory and make appropriate updates to policies and procedures. Highlight to laboratory management the future requirements for equipment replacement. Ensure current and future Data Integrity requirements are met and to highlight any deficiencies and implement and manage compliant solutions. Proactively champion technical continuous improvement projects in line with industry and Catalent global standards and best practice. Work as part of the Analytical Support team to: Host contractors & ensure documentation is received, and GMP & Safety requirements are met. Review and approval of all documentation in a timely manner to minimise equipment downtime. Ensure timely archiving. Manage day to day & long term projects with minimal supervision The Candidate: Exstensive GMP knowledge Previous experience working within a QC/AD Laboratory Technical expertise and knowledge of troubleshooting across laboratory instrumentation Degree in Scientific Subject or Equivalent technical experience 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 Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law. 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 DisabilityAccommodationscatalent.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.