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Catalent Pharma Solutions Associate QC Scientist - Cell Culture in Harmans, Maryland

The Associate Quality Control Scientist - Cell Culture is responsible for Quality Control Cell Culture testing to support Phase III/Commercial GMP manufacturing operations and Drug Substance/Drug Product release. Works in a fast-paced environment supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance and sterile finished drug product.

Catalent Cell and Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with 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.

Position workweek is Friday - Monday and will reside at our Harmans/BWI site.

The Role/Job Duties:

  • Perform adherent and cell culture testing in a Phase III/Commercial GMP Manufacturing facility. Includes but is not limited to: thawing, enumeration, passaging and cryopreservation of various cell line types required for QC assays.

  • Provide support to analytical/process development to onboard new client assays or enhancement to the testing capabilities of the cell culture laboratories.

  • Provides input on SOP revisions and may assist in the creation and editing of protocols.

  • Works closely with manufacturing and QA to coordinate cell culture activities required to support manufacturing operations and product release activities.

  • Report and investigate OOS/OOT or other deviations from approved procedures/processes.

  • Effectively communicates results of own work through discussions and documentation with some input from supervisor.

  • Flexibility in following unique campaign requirements that may include off-hour and weekend work.

Experience & Education:

  • A.S in a Life Sciences discipline and 1-4 years of relevant experience working in GMP clean rooms performing cell culture testing.

  • Experience with aseptic techniques.

  • Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks – requires strong attention to detail.

We will identify candidates based on the following:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits:

  • Join a high growth and fast paced organization with a people focused culture

  • Global exposure, defined career path and annual performance review and feedback process

  • Competitive Medical, Dental, Vision and 401K

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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.

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