Associate III, Manufacturing Fill/Finish
Catalent Pharma Solutions is looking to hire a Manufacturing Associate III within our Fill/Finish team on 2nd shift to support our Gene Therapy Team in Baltimore, MD.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
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 Baltimore location (https://biologics.catalent.com/our-locations/north-america/baltimore-usa/) . 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.
The Manufacturing Associate III Fill/Finish is responsible for supporting the overall GMP Fill/Finish manufacturing processes in accordance with Good Manufacturing Practices GMP). Accountable for final formulation and filling for the manufacture of biopharmaceutical products under cGMP. Performs media simulation runs of processes as needed to ensure they are appropriately aseptic.
This is a full-time position and is 100% on-site. The schedule is Monday - Friday 2:00PM - 10:30PM.
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
Perform processing steps and manufacturing support activities, monitoring processes against batch records.
Complete and review GMP documentation and production records for accuracy, making timely corrections.
Assist in GMP clinical and commercial fill/finish activities, including vial filling, inspection, labeling, and qualification activities.
Demonstrate working knowledge of formulation and filling equipment, including maintenance and validation issues.
Perform routine manufacturing work using standard operating procedures and batch records.
Prepare reagents, buffers, and equipment for processing.
Ensure compliance with established internal control procedures.
Operate automated and semi-automated fill/finish equipment, environmental monitoring equipment, and basic GMP processing equipment.
Troubleshoot equipment problems, assist with equipment start-up and validation efforts, and support aseptic filling and packaging processes.
Document cGMP data and information for processing steps and equipment activities, and actively participate in training activities, managing individual training plans
Other duties as assigned
The Candidate
Bachelor's degree in a Scientific, Engineering or Biotech field with 3+ years of experience with Fill Finish biologic production processes under GMP compliance.
OR
Associate's degree in a Scientific, Engineering or Biotech field with 4+ years of experience with Fill Finish biologic production processes under GMP compliance.
OR
HS Diploma with 6+ years of experience with Fill Finish biologic production processes under GMP compliance.
Knowledge and ability to apply scientific principles utilized to solve operational, as well as routine production tasks.
Ability to work in, training for, or practical knowledge of clean room/aseptic environment operations
Working knowledge of documentation including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports.
Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
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 required.
The anticipated salary range for this position in Maryland is $74,000 to $92,000 plus shift differential and annual bonus 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
Defined career path and annual performance review and feedback process
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 Reimbursement
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.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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 HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
