Downstream Process Development Jobs in Gaithersburg, MD

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.

We have an opportunity for an Associate II, Manufacturing to join our team. In this role, you will support GMP upstream or downstream manufacturing processes for bulk biologics from microbial and cell culture systems. You will apply your knowledge to solve operational and routine tasks for Phase I/II and commercial GMP manufacturing. This position reports to the Supervisor, Manufacturing and plays a key role in ensuring compliance and operational excellence.

Shift: Day shift, 7am-7pm on a 2-2-3 rotation
Location: Harmans, MD - BWI
100% Onsite

• Complete Batch Production Records under current Good Manufacturing Practices and document processes using Standard Operating Procedures and Batch Production Records
• Generate operational protocols and internal or external documents including Standard Operating Procedures, Batch Production Records, deviations, and summary reports
• Collaborate with Process Development and Manufacturing Sciences and Technology teams to transfer new projects into GMP
• Generate and revise internal and external documents such as Standard Operating Procedures and Batch Records
• Support initiation and closure of deviations; may lead departmental investigations and close deviations and Corrective and Preventive Actions
• Troubleshoot process and equipment issues; work with Facilities and Validation to maintain manufacturing equipment
• Recommend equipment and supply purchases for production areas
• Develop creative solutions to operational problems using knowledge of available theories and proven solutions
• Work closely with production management on current and new manufacturing projects to develop processes and techniques to meet objectives and avoid delays
• Collaborate with various departments and assist other teams as needed
• Interact with clients during manufacturing campaigns; may oversee and escort person-in-plant during campaigns
• Participate in facility expansion and equipment validation activities
• Maintain full training in all GMP manufacturing operations and documentation while adhering to safety guidelines
• Perform other duties as assigned

• High School diploma or General Education Diploma with 4+ years of experience in upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR Associate's degree in a Scientific, Engineering, or Biotech field with 2+ years of experience in upstream or downstream biologic production processes under GMP compliance OR Bachelor's degree in a Scientific, Engineering, or Biotech field with 1+ years of experience in upstream or downstream biologic production processes under GMP compliance
• Strong knowledge and ability to apply scientific principles to solve operational and routine production tasks
• Excellent documentation skills including comprehension, review, and establishing Batch Production Records, Standard Operating Procedures, deviations, and summary reports
• Team-oriented with the ability to collaborate effectively across Manufacturing, Quality Control, Quality Assurance, Regulatory, and Materials Management functions.
• Strong written and verbal communication skills with proficiency in English.
• Ability to work flexible schedules, including shift, overtime, and weekend coverage as required by production needs.
• Capable of performing physical requirements of the role, including lifting up to 40 pounds and extended periods of standing, walking, bending, reaching, pushing, and pulling.
• Ability to work safely and effectively in a manufacturing environment while maintaining a strong focus on quality, compliance, and operational excellence.

The anticipated hourly rate for this position in MD is $31.25 - $36.05 Plus Bonus. The final hourly rate 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.

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• 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 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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