Specialist II, MTO

Specialist II, Manufacturing Technical Operations (MTO)

About Site

Catalent’s Baltimore site is a leading facility specializing in biologics development and manufacturing, offering state-of-the-art capabilities for clinical and commercial supply. The campus provides an advanced environment where teams collaborate on innovative solutions to support life-changing therapies. With a strong focus on quality and scientific excellence, the site fosters a dynamic and supportive workplace that values expertise and continuous improvement. Employees here are part of a mission-driven culture dedicated to delivering critical treatments to patients worldwide, making it an inspiring place to grow your career in the biopharmaceutical industry.

Position Summary

We have an opportunity for a Specialist II, MTO to join our team and support manufacturing associates in meeting batch record review and disposition schedules to adhere to lot release dates. This role involves executing root cause investigations, owning and authoring deviations, driving continuous improvement efforts, and revising GMP documents such as SOPs and manufacturing batch records. The Specialist II, MTO will also be responsible for quality reports and supporting operational excellence. This position reports to the Manager,

Manufacturing Technical Operations.

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, meet quality expectations, 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 in support of 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 4 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 5 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g., production, development, process engineering, technical services, or related field) OR
• Associate’s degree or high school diploma with 6-8 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g., production, development, process engineering, technical services, or related field).
• Knowledge of GMP, Food and Drug Administration (FDA) regulations, and documentation procedures required.
• Experience in quality systems regulations.
• Previous experience in process deviation investigations and remediation, including major and/or critical deviations.

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 $95,000 – $105,000. 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 [email protected]. 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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