Operator I, Drug Substance Formulation

Company: Disability Solutions
Location: Bloomington
Posted on: October 24, 2024

Job Description:

Operator I, Formulation --Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--The Drug Substance - Operations department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.The Formulation/Support team executes GMP formulations of various growth production medias and feeds to support the upstream process, as well as a variety of different buffers and sanitization solutions to support the downstream purification process. The Formulation Department utilizes Master Batch Records and SOPs in a cGMP environment, focusing on 'right first time' and on-time delivery for each formulation.The Operator I, Drug Substance is responsible for the formulation of GMP solutions (liquid medias/feed, buffers, sanitizing solutions) using Raw Materials that are consumed/used throughout the upstream and downstream processes. This is a fulltime position working 12 hours 6PM - 6:30AM on a 2/2/3 rotationCatalent 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

• Follows detailed Batch Record and procedures to formulate drug substance
• Performs aseptic techniques within in a clean room environment; safely operates Single Use Mix tanks to support large-scale formulations, as well as required equipment for small scale batches (
• Uses basic biomanufacturing equipment such as tube fusers, tube sealers, pumps, balances, pH meters, stir-bars, and other applicable manufacturing equipment; completes cleanings as required completing routine and basic preventative maintenance of equipment
• Identifies and raise opportunities for procedural improvements.-- Supports continuous improvement initiatives
• Assists in stocking and staging production suites
• Addresses corrections to all executed documentation in a timely manner to support lot release
• Works scheduled shift and other off-shift coverage as required
• Executes other duties as assignedThe Candidate
  • High School/GED
  • 0-2 years of experience
  • GMP experience preferred
  • Occasional stooping, kneeling, crouching, bending, carrying, grasping; frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 50 pounds
  • Ability to operate within a clean room environment as needed
  • Must be able to read and understand English-written job instructions and safety requirements-----Why You Should Join Catalent--
    • Competitive medical benefits and 401K
    • 152 hours of PTO + 8 Paid Holidays
    • Dynamic, fast-paced work environment
    • Opportunity to work on Continuous Improvement ProcessesCatalent 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, Bloomington , Operator I, Drug Substance Formulation, Other , Bloomington, Indiana