Senior QC Scientist - LIMS Admin

The LIMS Administrator will be responsible for account management and implementation within the LabVantage Laboratory Information Management System (LIMS) implemented at the Catalent Pharma Solutions, BWI Harmans site. This position will be responsible for providing end-user support for all analytical groups as well as compliance to global Catalent and internal policies and procedures. Additionally, the LIMS Administrator may be tasked to participate in a global/local process for general or Catalent Global applicable design modifications.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The role:

• Administer accounts, roles and system function per global/local LIMS procedures.
• Solve end-user LIMIS template and end-users LIMS data entry issues.
• Work with IT and Quality personnel to ensure system compliance.
• First-line support for end-user LIMS template and data entry issues.
• Assist in the development and implementation of a site process for the scheduling and status tracking of all site LIMS Master Data, including needs for Raw Material, Finished Goods, and Stability testing.
• Work to maintain site and Catalent Global requirements of LIMS.
• Maintain and update site and/or Catalent Global Standard Operating Procedures (SOPs).
• All other duties as assigned.

The candidate:

• Bachelors degree from four-year college or university preferred in any of the following disciplines: Pharmacy, Biology, Chemistry, Engineering, Information Technology or related discipline
• 5+ years of experience in the Pharmaceutical or Biotech industry or relevant business experience. Experience with LIMS or Material Management System is preferred.
• Self-starter with the ability to work independently and proactively to resolve issues and fill unmet needs. Manages their own time and tasks under minimal supervision.
• Strong analytical problem-solving skills and a demonstrated ability to resolve complex problems.
• Background in testing operations and requirements for analytical chemistry, microbiology, or other pharmaceutical testing or release is required.
• Knowledge of cGMPs and other regulatory requirements relative to LIMS system and validation procedures is preferred.
• Ability to use Excel, Word, and other core office systems.
• Knowledge of the use of LIMS in a pharmaceutical laboratory, preferably LabVantage LIMS is preferred.
• Maintain high quality documentation in accordance with applicable regulatory guidance and Site SXPs.

The anticipated salary range for this position in Maryland is $93,280-$128,260 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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, including disability and veterans.

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE .