This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
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 SummaryWe 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% OnsiteThe RoleInitiate quality records and conduct deviation investigations that meet industry and Catalent expectationsLead or manage investigations including root cause analysis and assess product impact using input from various departmentsDevelop, execute, and oversee Corrective and Preventive Actions (CAPAs)Provide technical leadership to ensure investigations are technically sound and corrective actions are effectiveSupport technology transfer and process monitoring as neededWork with the team to monitor critical process parametersRevise 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 investigationsProvide real-time, on-the-floor response for operational deviations by gathering information and completing initial event reportsActively participate in training activities and manage individual training plansPerform other duties as assignedThe CandidateMinimum RequirementsMaster'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) ORBachelor's degree in a scientific, engineering, or biotech field with 8 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environment ORAssociate degree or high school diploma with 8-10 years of experience in biopharmaceutical manufacturing processing in a GMP compliance environmentStrong 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 & BackgroundPrevious 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 equipmentPayThe 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 CatalentDefined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesCompetitive paid time off plus 8 paid holidaysCommunity engagement and green initiativesMedical, dental, and vision benefits effective day one of employmentTuition reimbursementCatalent 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.
Worksite address
harmans, MD, 21077, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.