Oxford Global Resources is looking for a "Person in Plant", a technical operations specialist for a Janssen's CMO located in France.
Functions
Technical and manufacturing integration of the products into the supply chain.
Single point of contact for the project team pertaining to plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site based documentation, planning, risk management) including launch support.
JSC technical input and technical acceptance of the product into the supply chain including metrics through a process of "touch points", thereby ensuring "one voice of the cstomer" across projects and across plant.
Contribution, review and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of technical expertise (e.g., platforms, engineering, SME's) into project execution and technical implementation at the manufacturing site level.
Knowledge and skills
Bachelor's Degree with a concentration in pharmacy, science, or an equivalent technical discipline.
Minimum of 5 years work experience in a regulated pharmaceutical environment.
Experience in pharmaceutical aseptic manufacturing operations or quality assurance.
Detailed knowledge of GMPs related to pharmaceutical production.
Strong interpersonal and written/oral communication skills.
Ability to quickly process complex information and make critical decisions with limited information required.
Advanced degrees are a plus and may reduce the experience required.
Experience in vaccines production preferred.
Proficient in applying process excellence tools and methodologies is a plus.
Experience working with external manufacturers preferred.
Conditions
Temporary position: 12 months.
Salary: Very attractive and competitive- according to the skills and experience of the candidate
Location: Lyon
Starting Day: ASAP
