ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Lead Production position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its Pennsylvania-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.
- Responsible for the Lead the execution of all clinical drug product (DP) batches; directly accountable for right first-time quality.
- Perform all activities supporting the production of sterile DP, including but not limited to:
- Operation of the filling line
- Formulation of buffers and dilution
- Preparation of components and supplies including use of the autoclave and part washer
- Documentation (batch records, logbooks, etc)
- Routine in-process analytical testing, visual inspection, and batch record review.
- Perform front line supervision of shared plant manufacturing resources and DPO product scientists during GMP clinical production.
- Provide training on SOP's, aseptic technique, and activity-based competency assessments.
- Author and maintain SOP's required to support clinical GMP production of sterile DP.
- Coordinate calibration and preventive maintenance activities.
- Supports Deviation investigations and implementation of CAPA's. Supports and executes ongoing validation activities and change controls.
- Supports the development of batch records, test protocols, sampling plans.
- Supports operation of a non-GMP development Lab, including reference standards, tox fills, and other early product development studies.
Skills and Requirements:
- Bachelor's Degree in related discipline.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Maya Smith at + 267-405-6995 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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