Associate II, Manufacturing

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus features two manufacturing facilities and is situated 5 miles from Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. It is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 facility is EMA and FDA approved, spans approximately 200,000 sq. ft., and houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, under development at approximately 145,000 sq. ft., will include 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.

About the Role

We have an opportunity for an Associate II, Manufacturing to support GMP upstream or downstream manufacturing processes for bulk biologics from microbial and cell culture systems. In this role, 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: Night shift, 7pm-7am on a 2-2-3 rotation
Location: Harmans, MD - BWI (100% onsite)

Responsibilities

• 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.

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 $31.25 – $36.05 plus bonus. The final hourly rate offered to a successful candidate may vary and will be dependent on several factors, including experience, skills, education, and business needs.

Benefits

• 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.