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Manufacturing Associate II

Summary:

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location (https://biologics.catalent.com/our-locations/north-america/baltimore-usa/) . The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.

The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.

The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.

Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing. Lifting to 40 lbs., unassisted may be required at times. Frequent standing and walking is required, as this role requires presence on the manufacturing floor. Shift work and weekend work is required.

This is a full-time on-site position, 7pm-7am

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:

• Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps

• Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports

• May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP

• Generate and revise internal and external documents (SOPs, BRs)

• Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs

• Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment

• Recommend equipment and other supply purchases within the production areas

• Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions

• Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays

• Work closely with various departments and aid other teams as necessary

• Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns

• Participate in facility expansion and equipment validation activities

• Is fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines

• Other duties as assigned

The Candidate:

• HS or GED with 4-7 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR

• Associate’sdegree in a Scientific, Engineering or Biotech field with 2-4 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR

• Bachelor’s degree in a Scientific, Engineering or Biotech field with 1-3 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance

• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks

• Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports

• Thorough knowledge of current Good Manufacturing Practices (cGMP’s), and all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.

• Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).

• Able to fluently communicate in English. Exhibits excellent written and oral communication skills.

• Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management

P osition Benefits:

• Defined career path and annual performance review and feedback process

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 hours of paid time off annually + 8 paid holidays

• Competitive salary with yearly bonus potential

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

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 (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.

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