Senior QC Scientist – LIMS Administration

Posted 9 Days Ago
Be an Early Applicant
Harmans, MD
93K-128K Annually
Senior level
Biotech • Pharmaceutical
The Role
The Senior QC Scientist will oversee the administration of the LabVantage LIMS, providing end-user support, ensuring compliance with global policies, managing accounts, roles, and system functions, and assisting in the development of data tracking processes. The role requires knowledge of pharmaceutical laboratory requirements and regulatory standards.
Summary Generated by Built In

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 is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

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).

The candidate:

  • Bachelor’s degree from four-year college or university 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.
  • Knowledge of cGMPs and other regulatory requirements relative to LIMS system and validation procedures is preferred.
  • Knowledge of the use of LIMS in a pharmaceutical laboratory, preferably LabVantage LIMS is preferred.

The anticipated salary range for this position in Maryland is $93,280-$128,260 plus an annual bonus. 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 [email protected]. 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 [email protected] for us to investigate with local authorities.

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

Top Skills

Lims
The Company
HQ: Somerset, NJ
13,715 Employees
On-site Workplace
Year Founded: 2007

What We Do

Catalent Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. Since becoming a publicly traded company in 2014, we have grown to become a community of approximately 19,000+ workers who support over 7,000 products for over 1,000 customers around the world. We share a common goal: to put patients first and help people around the world live better and healthier lives.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. We have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging results.

more products. better treatments. reliably supplied.™

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

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 life.

Grow with us. Be challenged. Make a personal impact.

Visit https://careers.catalent.com/us/en to explore career opportunities

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