Upstream Manufacturing Lead (1st Shift)

Company: Disability Solutions
Location: Severn
Posted on: November 20, 2024

Job Description:

Summary: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, 7am-7pm 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:
          • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives--
          • 152 hours of paid time off annually +--8--paid holidays--
          • Competitive salary with yearly bonus potential--
          • Community engagement and green initiatives--
          • Generous 401K match and Paid Time Off accrual--
          • Medical, dental and vision benefits effective day one of employment--
          • Tuition 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.Visit 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 . 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.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Reston , Upstream Manufacturing Lead (1st Shift), Other , Severn, Virginia