Manufacturing Associate II - Fill/Finish

Company: Disability Solutions
Location: Baltimore
Posted on: November 14, 2024

Job Description:

Manufacturing Associate II, Fill Finish(2nd shift)Position Summary: ----Catalent Cell and Gene Therapy is looking to recruit a Manufacturing Associate II, Fill Finish to join our growing team in Baltimore, MD.The Manufacturing Associate Fill/Finish II is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for Phase I/II/III & commercial GMP manufacturing.----The Manufacturing Associate Fill/Finish II is critical to our patients.---Manufacturing life-saving medicines right the first time with patient safety in mind is our priority.--- Quality, safety and on-time delivery is a must to be successful in this role!--This role is on 2nd shift, Monday - Friday 2:00 pm - 10:30 pm. ------Catalent 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

• Follow current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and Batch Production Records (BPRs) to manufacture sterile drug product in an aseptic, clean room environment.-- Complete detailed documentation of all required processes and manufacturing steps.
• Setup and operate equipment and machinery utilized in the manufacture of finished drug products per applicable SOPs. Perform equipment and area cleaning processes as necessary.
• Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment. Support equipment and area preventive maintenance and repair as necessary.
• Work within an aseptic clean room in full sterile gowning.
• Generate internal or external documents including SOPs, BPRs, deviations and summary reports as needed to support manufacturing objectives.
• May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP.
• Support initiation and closure of deviations.--
• 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 activities.
• Perform other duties as assigned.The Candidate:
  • HS or GED with 4-7 years' experience in cGMP-regulated aseptic/Sterile Manufacturing--OR--
  • Associate degree in a Scientific, Engineering or Biotech field with 2-4 years' experience in cGMP-regulated aseptic/Sterile Manufacturing-- OR--
  • Bachelor's degree in a Scientific, Engineering or Biotech field with 1-3 years' experience in cGMP-regulated aseptic/Sterile Manufacturing--
  • Aseptic/sterile manufacturing experience required.
  • Working knowledge of documentation including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports preferred.
  • Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
  • Understand routine procedures upon which they have been trained.
  • Possesses a basic understanding of equipment function and applications.-- Proficient in MS Office and related PC skills.The anticipated salary range for this position in Maryland is $58,240 to $80,080 plus shift differential and 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.Why you should join Catalent:
    • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
    • Defined career path and annual performance review & feedback process
    • Cross-functional exposure to other areas within the organization--
    • Medical, Dental, Vision, and 401K are all offered from day one of employment
    • 152 hors of PTO and 8 paid holidays
    • 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 .

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