Associate III Manufacturing
Associate III Manufacturing
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$ 74000 - 92000
1 Vacancy
Job Description
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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.
Our FDAlicensed stateoftheart 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 ourBaltimore location. The campus is close to Washington DCs I270 Technology Corridor top universities and government agencies. The Harmans/BWI1 EMA and FDA approved facility at approximately 200000 sq. ft. houses 10 CGMP manufacturing suites fill/finish central services testing labs and a warehouse. The Harmans/BWI2 facility at approximately 145000 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 fulltime position and is 100 onsite. The schedule is Monday Friday 2:00PM 10:30PM.
Catalent is committed to a Patient First culture through excellence in quality andcompliance 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 semiautomated fill/finish equipment environmental monitoring equipment and basic GMP processing equipment.
- Troubleshoot equipment problems assist with equipment startup 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
- Bachelors degree in a Scientific Engineering or Biotech field with 3 years of experience with Fill Finish biologic production processes under GMP compliance.
OR
- Associates 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 SOPs deviation & summary reports.
- Must be teamoriented (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 $74000 to $92000 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 multistate 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 7000 lifesaving and lifeenhancing 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 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.
California Job Seekers can find our California Job Applicant Notice HERE.
Required Experience:
IC
Employment Type
Full-Time
