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Upstream Manufacturing Group Lead (PM Shift) - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 11/21/2024
Manufacturing Group LeadSummary: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--. 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.The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with GMP cleaning processes, solution preparation, master/working cell bank production, upstream cell culture and viral vector production, downstream purification, and fill/finish operations. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.The Manufacturing Group Lead is a working lead responsible for daily execution of the operations schedule to deliver the desired output in a safe, compliant, and efficient manner.-- The Group Lead has broad knowledge of manufacturing theories and principles, demonstrates systematic problem-solving skills, and integrates continuous improvement into the larger manufacturing organization guided by The Catalent Way.--This is a full-time on-site position, 7pm-7am 2-2-3Catalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--The Role: - Performs daily production activities to ensure schedule adherence
- Coordinates, with indirect supervisory responsibilities, production activities for a group of Manufacturing Associates / Technicians
- Practices operational excellence methodologies in The Catalent Way and acts as a change agent for continuous improvement efforts
- Leads tier 1 meetings in the review and execution of people, safety, quality, delivery, and cost objectives
- Assists the supervisor with rapid response and problem resolution for daily issues
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines
- Completes Batch Production Records under cGMP, and documents in detail using SOPs and BPRs for the processes and manufacturing steps
- May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP production
- Generate and revise internal and external documents (SOPs, BRs)
- Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
- Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
- Recommend equipment and other supply purchases within the production areas
- Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
- Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
- Participate in facility expansion and equipment validation activitiesThe Candidate:
- Bachelor's or Master's degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 4 years' related experienceOR
- Associate's degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 6 years' related experienceOR
- High School Diploma with minimum of 7 years' related experience
- Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
- Demonstrates daily focus on safe behaviors and adept at recognizing unsafe conditions
- Thorough understanding of quality systems in regulated environment and fully committed to right first time (RFT) execution
- Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports
- Proficient knowledge and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
- Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups)
- Actively pursues learning of required skills, new skills, and new equipment
- Possesses proficient equipment understanding, including understanding equipment function and application
- Proficient in MS Office and related PC skills
- Must have the ability to work an available set shift; there will be times when overtime is requiredThe anticipated salary range for this position in Maryland is $ $83,000 to $115,000 plus shift annual bonus, when eligible.-- 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.Position Benefits:
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