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Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
I. Position Overview:
The cGMP Biomanufacturing group is responsible for current Good Manufacturing Practices (cGMP) production activities, including Master/Working Cell Bank production, Upstream cell culture, Downstream protein/mRNA purification, and/or therapeutics production.
This position requires a variety of skills necessary for a cGMP Biomanufacturing environment. Independently perform Biomanufactuing operations, while adhering to SOPs and working in a cGMP compliant environment. Analyze and interpret results in written and oral format. Other duties will include Batch Production Record/data review, drafting technical documents protocols and reports, training/mentorship of staff and driving process improvement initiatives. The position is expected to follow detailed instructions and established procedures with minimal supervision. The position is expected to follow detailed instructions and established procedures with infrequent supervision.
II. Specific Duties, Activities, and Responsibilities:
- Lead/co-lead cGMP Biomanufacturing production activities
- Daily review of executed cGMP documentation (BPRs, forms)
- Coordinate w/Supervisor to prioritize and schedule activities to meet deadlines
- Perform aseptic techniques within in a clean room environment
- Execute and document cGMP Biomanufacturing activities
- Operate cGMP Biomanufacturing equipment such as pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and BioSafety Cabinets (BSC) or Laminar Flow Hoods (LFH)
- Maintain effectiveness of Quality system
- Stage raw materials/components for use within cGMP Biomanufacturing
- Performs general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards
- Accurately completes routine and preventive maintenance on Biomanufacturing equipment
- Routinely draft and revise Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA)
- Lead deviation investigations and change control/protocol execution in a time sensitive fashion
- Execute equipment qualification/validation protocols, as required
- Train other Biomanufacturing staff, as needed
- Support continuous process improvement initiatives
- Actively participates in team meetings and/or training sessions
- Perform Media/Solution Preparation
- Ability to work scheduled shift and other off-shift coverage as required
- Other duties as assigned
- Operate Biomanufacturing equipment, such as, chromatography skids, Normal Flow Filtration/Tangential Flow Filtration skids
- Perform column, membrane adsorption and size-exclusion chromatography as well as viral reduction/filtration steps
- Perform Bulk Drug Substance filling operations
- Perform routine protein purification analytics (protein concentration, pH, conductivity)
- Become SME of appropriate topics: Unicorn software, TFF theoretical operation, Chromatography theories (presentation of choice to team), Column packing, JDE (or current MRP software)
- Trains other Biomanufacturing staff as needed.
- Successfully perform purification techniques/operations such as Chromatography, AEX Membrane, Tangential Flow Filtration (TFF), Viral Filtration (VF), and Bulk Drug Substance (BDS) filling.
- Review un-executed BPRs for protocol errors or material shortages.
- Assists with drafting Standard Operating Procedures (SOP) and Job Aids (JA)
- Work with Change Controls and events
- Perform complex projects or side tasks
- Review executed BPRs for Manufacturing close-out
III. Position Requirements:
- M.S./M.A. in Biotechnology, or related field, with minimum of 1 years' experience in related work; or
- B.S./B.A. in Biotechnology, or related field, with minimum of 2 years' experience in related work; or
- Associates Degree/Certificate/Diploma in laboratory science with minimum of 4 years' experience in related work.
- High School Diploma or equivalent with a minimum of 5 years' experience in related work.
- Clean room, aseptic technique, and/or general lab equipment experience
- cGMP, Good documentation practices (GDP), Good Laboratory Practices (GLP) knowledge
- Following standard operating procedures
- Experience operating, maintaining and troubleshooting Biomanufacturing-related equipment
- Experience with SUBs, SUMs, Unicorn and/or Delta V software(s)
- Experience with Trackwise, Compliancewire or other electronic tracking software
Catalent 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.
Catalent is committed to the health and safety of its employees, visitors and the customersand patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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C atalent is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 (see below) . 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 (see below) for us to investigate with local authorities.