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PRODUCTION SPECIALIST IV in Hopkinton, MA

Curia is a leading biologics company specializing in antibody and protein engineering, cell line development, and protein production. Our services can be fully integrated, creating a customized solution for all our customer’s molecular biology, cell line, and protein needs.

The Production Specialist IV serves as Technical Lead for their designated shifts. The incumbent will drive GMP operations, adherence to schedule and be responsible for drug substance, solutions production.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

We proudly offer

+ Generous benefit options (eligible first day of employment)

+ Paid training, vacation and holidays (vacation accrual begins on first day of employment)

+ Career advancement opportunities

+ Education reimbursement

+ 401k program

+ Pension (for union employees)

+ Learning platform

And more!

Essential Functions:

+ Must be available to work any shift, including day/nights/weekends

+ Lead Manufacturing daily meetings to support the organization

+ Own deviations, CAPAs, change controls, DCRs, equipment status

+ Perform GMP operations for upstream, downstream and RNA

+ Support buffer and media solution generation

+ Support process science with development batches

+ Help facilitate adequate completion of calibration, PM and new equipment implementation

+ Facilitate Root Cause Analysis for deviations and safety events, as needed

+ Provide Manufacturing signoff on executed documents and SOP revisions

+ Create and revise SOPs and documents, SOP’s batch records and solution records

+ Participate in project meetings to ensure appropriate Manufacturing oversight and engagement

+ Drive activities to improve GMP best practices and suite cleanliness

+ Support continuous improvement projects

+ Own shift-wide training for GMP equipment and operations

Requirements

+ Bachelor's degree in Science or related field or equivalent work experience

+ Minimum of 8-12 years’ directly applicable experience in the industry, including prior supervisory experience or equivalent combination of education and experience

+ Manufacturing areas require full gowning (e.g., ability to bend, kneel and stand on feet for long periods of time in a clean room or warehouse area)

+ Ability to read, analyze, and interpret technical procedures, or governmental regulations

+ Ability to write reports, business correspondence, and procedure manuals

+ Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

+ Ability to calculate figures and amounts such as cells viability, cells seeding, pH adjustments and other process mathematical formulas

+ Proficient in the use of MS Word, Excel, Outlook. Must be able to learn manufacturing software

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

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