Central Services Technician III (Media Fill / Buffer Prep)

Position: Central Services Technician III (Media Fill / Buffer Prep)
Company: Catalent Gene Therapy
Location: Harmans, Maryland 21077
Shift: 7pm to 7am, 2-2-3 rotation
Compensation: $58,240 to $80,080 15% shift differential annual bonus

Catalent 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.

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.

The Central Services Technician III is responsible for supporting the manufacturing processes in Central Services, 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.

Responsibilities:

• Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps, and a focus on proactive ‘right the first time’ executions.
• Proven ability to utilize central services processing equipment according to established SOPs. This equipment includes but is not limited to biological safety cabinets, various mixers, autoclaves, washers, balances/scales, Ph/ Conductivity meters
• 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
• Assist in the scheduling of daily activities for the Central Services department.
• 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

Requirements:

• HS or GED with 5 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR
• Associate degree in a Scientific, Engineering or Biotech field with 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 2-3 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

Why you should Join Catalent

• Patient first mentality, help make life-saving / enhancing gene therapies!
• Defined career path and high trajectory for professional growth
• Cross-functional exposure to other areas within the organization
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• 152 hours of PTO and 8 paid holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 8,000 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 80 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference!

Job Type: Full-time

Pay: $58,240.00 - $80,080.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 12 hour shift
• Overnight shift
• Rotating weekends

Ability to Relocate:

• Harmans, MD 21077: Relocate before starting work (Required)

Work Location: In person

Salary : $58,240 - $80,080