Supervisor cGMP Biomanufacturing - DownstreammRNA
Supervisor cGMP Biomanufacturing - DownstreammRNA
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Job Description
Supervisor Biomanufacturing Downstream/mRNA
The Supervisor will oversee a team/shift responsible for Downstream manufacturing of biologics drug substance and mRNA & Molecular Therapeutics supporting direct and providing leadership Downstream/mRNA Biomanufacturing Supervisor will be responsible for his/her teams of production activities including column chromatography normal flow filtration / tangential flow filtration (TFF) viral reduction / filtration invitro transcription (IVT) and bulk drug substance filling in a clinical and commercial cGMP Supervisor will be present on the floor to support in compliance with SOPs and GMP guidelines provide coaching and development to employees and drive a right first time Supervisor will ensure batch manufacturing readiness meet production schedule deliverables drive a continuous improvement culture support Person in Plant (PIP) and continually optimize staff and operating model in support of client program requirements and site financial Supervisor will coordinate activities and drive standard work with Supervisors of other position generally supervises 515 direct Supervisor spends the majority of time assigning reviewing checking work assisting in the manufacturing suites and eliminating ordinary difficulties. This person also recommends candidates for hiring termination prepares and conducts performance reviews and salary reviews and applies company policies.
This is a fulltime onsite salaried position Sunday Wednesday 2:00pm to 12:00am
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:
- Authors and revises Standard Operating Procedures (SOP) Batch Production Records (BPR) and Job Aids (JA)
- Performs daily review and final signoff of executed cGMP documentation (BPRs forms)
- Supervises general cleanroom housekeeping including room and equipment cleaning(s) disposal of trash and recyclables and adherence to 5S standards
- Trains monitors and mentors direct reports on biomanufacturing activities; Mentors staff regarding regulatory requirements and supports operators with deviation management
- Holds 1x1s with employees; Leads team meetings and/or training sessions. Acts as Subject Matter Expert (SME) on biomanufacturing activities
- Supervises completion of routine and preventive maintenance on biomanufacturing equipment; Supervises/executes equipment qualification/validation protocols as required
- Supports deviation investigations and change control/protocol in a time sensitive fashion
- Drives and supports continuous process improvement initiatives.
- Other duties as assigned
The Candidate:
- Must have Masters Degree in a scientific engineering or biomanufacturing discipline with a minimum of 2 year of relevant experience OR
- Bachelors or Associates Degree in a scientific engineering or biomanufacturing discipline with a minimum of 4 years of relevant experience OR
- High School Diploma with a minimum of 6 years of relevant experience
- GMP experience required
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalentsponsored leadership programs such as NGGL GOLD LEAD Now GM Excellence and GROW) may be considered in place of external experience
- Position requires frequent sitting standing walking reading of written documents and use of computer monitor screen reaching with hands and arms talking writing listening.
- Occasional stooping kneeling crouching bending carrying grasping is required
- Must comply with EHS responsibilities for the position
- Individual may be required to lift and/or move 010 pounds frequently and occasionally moving and/or lifting up to 50 pounds
Why you should join Catalent:
- Defined career path and annual performance review and feedback process
- Diverse inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of paid time off annually 8paid 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:
Director
Employment Type
Full-Time
