Manufacturing Technical Operations Specialist III (MTO Specialist)

Catalent; Harmans (MD); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Medical benefits from day one

Tuition reimbursement

Paid time off

8 paid holidays

Job summary

Catalent is seeking an MTO Specialist, III to support Gene Therapies manufacturing at the Harmans, MD site. You will drive batch record review, manage deviations, and lead root cause investigations to ensure on-time lot release.

You will collaborate with cross-functional teams, revise GMP documents, and contribute to continuous improvement in a fast-paced aseptic environment on-site from 8am–5pm.

Qualifications

• Advanced knowledge of GMP regulations and FDA requirements.
• Experience leading deviation investigations and root-cause analysis.
• Proven ability to author and maintain technical documentation.
• Able to manage multiple priorities and lead cross-functional projects.

Responsibilities

• Initiate quality records and deviations investigations.
• Lead investigations including root cause analysis and assess product impact.
• Develop, execute, and oversee CAPAs.
• Provide technical leadership to ensure investigations are sound.
• Support technology transfer and process monitoring as needed.
• Revise batch records and SOPs; manage manufacturing documents.
• Lead continuous improvement projects and data analysis for investigations.
• Provide on-the-floor response for operational deviations and training.
• Perform additional duties as assigned.

Skills

GMP regulations

FDA requirements

Quality systems

Controlled documentation

Deviation investigations

Root cause analysis

CAPAs

Lean Six Sigma

Cross-functional collaboration

Analytical thinking

Education

Master’s degree in science/engineering/biotech

Bachelor’s degree in science/engineering/biotech

Associate degree or high school diploma (with 8–10 years GMP experience)

Job description

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 a MTO Specialist, III to join our team and support manufacturing operations. In this role, you will help ensure batch record review and disposition schedules are met to adhere to lot release dates. You will lead root cause investigations, manage deviations, drive continuous improvement, and revise GMP documents such as SOPs and manufacturing batch records. This position offers the chance to work closely with cross-functional teams and contribute to high-quality biopharmaceutical manufacturing.

Shift: Monday - Friday, 8am-5pm
Location: Harmans, MD - BWI
100% Onsite

The Role

• Initiate quality records and conduct deviation investigations that meet industry and Catalent expectations
• Lead or manage investigations including root cause analysis and assess product impact using input from various departments
• Develop, execute, and oversee Corrective and Preventive Actions (CAPAs)
• Provide technical leadership to ensure investigations are technically sound and corrective actions are effective
• Support technology transfer and process monitoring as needed
• Work with the team to monitor critical process parameters
• Revise and manage manufacturing documents such as batch records and Standard Operating Procedures (SOPs)
• Lead or support continuous improvement projectsConduct data gathering, trending, and data presentation to support investigations
• Provide real-time, on-the-floor response for operational deviations by gathering information and completing initial event reports
• Actively participate in training activities and manage individual training plans
• Perform other duties as assigned

Minimum Requirements

• Master’s degree in a scientific, engineering, or biotech field with 6 years of experience in biopharmaceutical manufacturing processing in a Good Manufacturing Practice (GMP) compliance environment (e.g., production, development, process engineering, technical services or related field) OR
• Bachelor’s degree in a scientific, engineering, or biotech field with 8 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environment OR
• Associate degree or high school diploma with 8-10 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environment
• Strong knowledge of GMP regulations, FDA requirements, quality systems, and controlled documentation practices.
• Experience leading deviation investigations, root cause analysis, remediation activities, and system troubleshooting efforts, including major and critical deviations.
• Proven ability to author, revise, and maintain technical documentation with strong technical writing and communication skills.
• Demonstrated success working cross-functionally, leading teams, and executing projects on time and within budget while communicating effectively with both technical and non-technical stakeholders.
• Strong analytical, problem-solving, and organizational skills, including familiarity with Lean Six Sigma methodologies, creative thinking, and the ability to manage multiple priorities.
• Collaborative team player committed to continuous professional development, with the ability to work on-site in a manufacturing/aseptic environment, including extended standing, walking, sterile gowning, and cleanroom operations.

Preferred Skills & Background

• Previous experience operating equipment such as incubators, single-use bioreactors, depth filtration skids, tangential flow filtration (TFF) skids, chromatography skids, single-use mixers, and in-process testing equipment

Pay

The anticipated salary range for this position in MD is $120,000 – $140,000 Plus Bonus. The final salary 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.

Visit Catalent Careers to explore career opportunities.

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

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.

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.