Lead Production
This vacancy has now expired. Please see similar roles below...
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.
Job Responsibilities:
- 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.
To Apply:
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.
#LI-MS2
#Scientific
Related jobs
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a dedicated QC Microbiologist to support our vaccine manufacturing site. This is a contract position located in Cambridge, MA.
Highly Competitive Salary
München (81249), Deutschland
Proclinical sucht einen engagierten regionalen Vertriebsleiter für die Osthälfte Deutschlands im Bereich Urologie.
Highly Competitive
Deutschland
Proclinical are currently in search of a dynamic Statistical Project Leader.
Highly Competitive
Tuttlingen, Germany
Proclinical sucht einen Systems Engineer - Instruments für einen Kunden aus der Medizintechnik-Branche.
Highly Competitive
Singapore River, Singapore
Proclinical are recruiting for a Senior eCommerce Manager APAC (6 months maternity cover) to join a pharmaceutical organisation.
Highly Competitive
Tuttlingen (78532), Deutschland
Proclinical auf der Suche nach einem Systems Engineer (m/w/d).
Highly Competitive
Singapore
Proclinical is seeking a dedicated Automation Engineer to provide technical support for smooth manufacturing operations.
Highly Competitive Salary
Lexington, USA
Proclinical is seeking a dedicated Project Manager to lead IT projects within business applications and IT infrastructure. This is a contract position located in Lexington, MA.
Highly Competitive Salary
Indianapolis, USA
Proclinical is seeking a dedicated and innovative Electrical Engineer to join our Engineering Operations Team. This is a permanent position located in Indianapolis, IN.
Highly Competitive Salary
New Haven, USA
Proclinical is actively seeking an Upstream Associate Scientist. This is a contract position located in New Haven, CT.