The Manufacturing Associate II Fill/Finish is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for Phase I/II & commercial GMP manufacturing.
The Manufacturing Associate II Fill/Finish is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role!
Follow current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and Batch Production Records (BPRs) to manufacture sterile drug product in an aseptic, clean room environment.
Complete detailed documentation of all required process and manufacturing steps.
Setup and operate equipment and machinery utilized in the manufacture of finished drug product per applicable SOPs.
Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment.
Generate internal or external documents including SOPs, BPRs, deviations and summary reports as needed to support manufacturing objectives.
May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP.
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.
Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.
Other duties as assigned
Diverse, inclusive culture
401(k) retirement savings plan with company match
19 days' Paid time off and 8 paid holidays
Medical, dental, and vision insurance
Flexible spending account
Employee discount programs
Robust Employee Referral Program
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.