Manufacturing Associate II

Catalent, Inc.; Glen Burnie (MD); On-site; USD 46,000 - 53,000; Full time

Job summary

Catalent, Inc. is seeking an Associate II, Manufacturing in Harmans, MD (on-site). The role focuses on GMP upstream or downstream production for bulk biologics, involving documentation, SOPs, deviations, and collaboration with Process Development and Manufacturing Sciences to transfer projects into GMP.

The position requires flexibility for shift, overtime, and weekend coverage. The candidate will participate in time-bound campaigns, support equipment validation, and maintain all GMP training

Qualifications

• 4+ years in upstream or downstream biologic production under GMP
• 2+ years with Associate’s degree in related field
• 1+ years with Bachelor’s degree in related field

Responsibilities

• Prepare Batch Production Records per GMP
• Draft and revise SOPs and batch records
• Collaborate with Process Development and Manufacturing Sciences
• Troubleshoot equipment and process issues
• Support deviations and CAPAs
• Assist in facility expansion and validation activities

Skills

GMP knowledge

Documentation

Cross-functional collaboration

Biologic production

Education

Bachelor’s degree in Science/Engineering/Biotech

Associate’s degree in Science/Engineering/Biotech

Tools

Batch Production Records

SOPs

Job description

Associate II, Manufacturing

About Site

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.

Position Summary

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

The Role

• 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

The Candidate

Minimum Requirements

• 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.

Pay

The anticipated hourly rate for this position in MD is $33.65 – $38.46 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.

Why You Should Join Catalent

• 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.

Catalent is an Equal Opportunity Employer, including disability and veterans.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.