Manufacturing Associate I

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. 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 I perform and documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.
Shift work and/or weekend work may be required at times.

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

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:

• Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record.
• Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks.
• Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices.
• Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMP’s
• Performs the weighing, dispensing of raw materials for media and buffers
• Performs the preparation of small and large volume media and buffer solutions, filtration, and transfer of product.
• Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.
• Dispensing, labeling, transfer/staging of raw materials and parts
• Assembly/disassembly, cleaning and sterilization of components, parts, and equipment
• Maintaining equipment, area, and cleaning logbooks
• Cleaning sanitizing production rooms and equipment
• Stocking production and cleaning supplies
• May author/ review/improve SOP’s, batch records, protocols, and technical reports
• Actively participates in training activities, managing their individual training plan
• Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.
• Other duties as assigned

The Candidate:

• High School Diploma with a minimum of 2-4 years GMP Manufacturing experience,
• OR
• Certificate and/or associate degree in a scientific, engineering or biotechnology discipline with a minimum of 0-2 years related experience; coursework with biotechnology focus highly desirable ,
• OR
• Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 0-1 years relevant experience
• Basic knowledge of current Good Manufacturing Practices (cGMP’s). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
• Familiar with or experience with cGMP Biotech or Pharmaceutical operations:
• 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.

Position 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 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.

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