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Manufacturing Associate IV

Company: Catalent Pharma Solutions, Inc.
Location: Rockville
Posted on: September 24, 2022

Job Description:

Manufacturing Associate IV

Catalent Cell & Gene Therapy is looking to recruit a Manufacturing Associate IV to join our growing team in Rockville/Gaithersburg, MD.

The Manufacturing Associate IV is responsible for supporting the overall GMP upstream or downstream manufacturing process as well as training all Manufacturing Associates, through the application of broad knowledge of theories and principles utilized to solve operationally. The MA IV is responsible for assisting with developing and providing training presentations as the Manufacturing subject matter experts. well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.

The Role:

* Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
* 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
* 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


* Works closely with purification management to initiate new manufacturing projects and helps develop processes/techniques to meet contract objectives
* Perform buffer preparations, in-process sampling, formulation of bulk drug substance
* Has excellent understanding and knowledge of isolating and purifying proteins from microbial and cell culture processes
* Extensive experience with chromatography equipment, columns, TFF, CIP procedures and processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity)


* Leverage's knowledge and application of the theories and principals utilized to solve operational, as well as routine tasks in the operation of microbial or cell culture processes (media/buffer prep, cell passaging, bioreactor production, harvesting operations)
* Have excellent understanding and knowledge of mammalian, insect, viral and microbial processes
* Experienced with suspension and adherent cell cultures
* Experienced in using stainless and disposable single-use bioreactors (WAVE, Sartorius, Xcellerex)
* Extensive experience in producing Master and Working banks (mammalian, insect, viral and microbial)

The Candidate:

* HS or GED with 8 plus years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR Associate degree in a Scientific, Engineering or Biotech field with 7 plus years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR Bachelor's degree in a Scientific, Engineering or Biotech field with 6 plus years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
* Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
* Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports
* Shift work and/or weekend work is required at times.

Why Join Catalent:

* Potential for career growth within an expanding team
* 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
* Employee Stock Purchase Plan
* 19 days PTO and 8 paid holidays

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 customers and 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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers 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 for us to investigate with local authorities.

Keywords: Catalent Pharma Solutions, Inc., Rockville , Manufacturing Associate IV, Other , Rockville, Maryland

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