Manufacturing Technical Operations Specialist III (MTO Specialist)

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

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

PTO and holidays

Job summary

Catalent Pharma Solutions seeks an experienced Manufacturing Technical Operations Specialist III (MTO Specialist) to support GMP manufacturing for gene therapies at the Harmans, MD campus. You will lead investigations, manage CAPAs, and ensure batch records and SOPs meet release timelines while collaborating cross-functionally on process improvements.

The role requires on-site work, strong technical writing, and a track record of delivering quality biological manufacturing outcomes in a

Qualifications

• Master’s or Bachelor’s degree in a scientific, engineering, or biotech field with GMP experience.
• Experience leading deviation investigations, root cause analysis, remediation activities, and system troubleshooting.
• Strong technical writing, documentation control, and cross-functional communication skills.
• Experience working on-site in manufacturing/aseptic environments with Lean Six Sigma awareness.

Responsibilities

• Initiate quality records and conduct deviation investigations that meet industry and Catalent expectations.
• Lead 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.
• Revise and manage batch records and SOPs; participate in continuous improvement projects.

Job description

Manufacturing Technical Operations Specialist III (MTO Specialist)

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 projects
• Conduct 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

The Candidate 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. 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 [e-mail]. 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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Catalent, Inc. 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.