Senior Informatics Specialist

Catalent Baltimore , MD 21203

Posted 2 months ago

Job Description:

Position Overview:

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

Catalent Paragon Gene Therapy is looking to recruit a Sr. Informatics Specialist to join our growing team in Baltimore, MD

The Sr. Informatics Specialist is responsible for executing the adoption, validation, support, maintenance, and decommissioning of Chromatography Data System (CDS), Laboratory Information Management System (LIMS), Scientific Data Management System (SDMS), Electronic Lab Notebook (ELN), etc. for Catalent Maryland.

The Sr. Informatics Specialist role is critical to our patients as this individual will be instrumental in translating lab needs into requirements and focus on on-going process improvements.

The Role

  • Convert Catalent Maryland's laboratories' needs into requirements

  • Rollout the requirements and establish validation protocols (IQ/OQ/PQ)

  • Work to understand the laboratory processes and map the processes into enablement capabilities

  • Serve as the primary subject matter expert for Catalent Maryland's laboratories.

The Candidate

  • Minimum Bachelor's degree is required. Degree in Life Sciences is highly preferred. Advanced degree preferred.

  • Minimum 5 years GxP software or laboratory solutions experience is required.

  • Experience in biotechnology, pharmaceutical, or life sciences is required.

  • Experience working in a matrixed, multi-cultural, collaborative environment is preferred.

  • Knowledge of FDA regulations, including 21 CFR Part 11, GMP, GLP and GAMP is required.

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 team

  • Defined career path and annual performance review & feedback process

  • Cross functional exposure to other areas of within the organization

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

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

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.

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, 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.


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