We're hiring a 2nd Shift Associate III, Manufacturing role to support the Fill Finish team for our gene therapy facility in the University of Maryland's BioPark campus, in Baltimore, Maryland.
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 Associate III, Manufacturing is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for Phase I/II/III & commercial GMP manufacturing.
This is a full-time position and is 100% on-site. The schedule is Monday – Friday 2:00PM – 10:30PM.
Catalent’s FDA-licensed, state-of-the-art CGMP gene therapy facility specializes in upstream and downstream process development of viral vectors for clinical applications. The facility houses process development labs and CGMP cleanroom suites for Phase 1 and 2 programs focused on a variety of transformative technologies, including AAV and other viral vectors, vaccines, and oncolytic immunotherapies.
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
Follow current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and Batch Production Records (BPRs) to manufacture sterile drug product in an aseptic, clean room environment. Complete detailed documentation of all required processes and manufacturing steps.
Setup and operate equipment and machinery utilized in the manufacture of finished drug products per applicable SOPs. Perform equipment and area cleaning processes as necessary.
Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment. Support equipment and area preventive maintenance and repair as necessary.
Work within an aseptic clean room in full sterile gowning.
Generate internal or external documents including SOPs, BPRs, deviations and summary reports as needed to support manufacturing objectives.
May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP.
Support initiation and closure of deviations.
Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays.
Other duties, as assigned.
The Candidate
Bachelor’s or master’s degree in a technical discipline (e.g., biology, biotechnology, engineering) or related life science field, with a minimum of 4 years’ related experience.
High School diploma or associate’s degree in a technical discipline (e.g., biology, biotechnology, engineering) or related life science field, with a minimum of 5 years’ related experience.
Prior experience in cGMP biopharmaceutical manufacturing, highly preferred.
Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports.
Experience working in an aseptic environment, highly preferred.
Proficient in MS Office and related PC skills.
The anticipated salary range for this position in Maryland is $74,000 to $100,000 plus shift differential and annual bonus, when eligible. 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
Medical, dental, vision, and wellness benefits are effective on the first day of employment.
Potential for career growth on an expanding team and organization.
152 hours of paid time off annually plus 8 paid holidays.
Community engagement and green initiatives.
Engaging D&I Employee Resource Groups.
Tuition reimbursement program.
Generous 401K match.
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.
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