Job Description
One of our large pharma clients is seeking a Project Manager that will lead a multi-functional matrix team of people within the company and a 3rd party manufacturing location (CMO). There primary responsibilities are:
Support the technology transfer process team on activities related to successfully transferring product to a new external supplier manufacturing sites and routine operations
Colleague will work with different workstreams to organize and drive efforts to meet schedule within budget.
Management of routine team meetings to facilitate plan updates, decision-making, problem solving, escalations e.g. resourcing gaps, mitigations vs non-adherence to plan.
Self-driven and works independently to achieve milestones & goals.
Seeks help with scope when appropriate
Colleague will assist with generating knowledge transfer documents, technology transfer plans and other transfer related documents between sending / receiving sites
Colleague will provide first level review of technical documents generated by receiving site and coordinate internal technical review of sending site / project SMEs.
Colleague will participate/lead cross-functional team meetings between sending and receiving sites. As required colleague may be asked to lead technical investigations.
Colleague will support administrative activities for the workstream such as action/issue item tracking, generation of meeting minutes, coordination of focused working sessions between sending and receiving sites and follow up on actions.
Colleague will be responsible for providing/updating schedules on routine basis.
Provides timely and thorough project update reports to customers, via the established cadence and process.
Required Skills & Experience
B.S. in Chemical/Pharmceautical Engineering, Pharmacy, Chemistry or relevent disciplines
At least 10 years experience in Pharmaceutical Manufacturing Project management, and ability to build costs, resources and schedule for technical projects.
Experience with CAPEX projects, SI manufacturing, Tech Transfers; Analytical methods trouble shooting and remediation.
Sterile injectibles/DP experience in process validation, operations or quality preferable.
Knowledge in GMP and Broad knowledge of pharmaceutical manufacturing processes is essential to understand the basically project flow interactions. Experience in aseptic operations and equipment startup/qualification is a plus.
Lead/Support investigations
Excellent teamwork, and ability to navigate in different areas and work with multidisciplinary teams
Flexibility, ability to deal with ambiguity, and sense of personal ownership of deliverables and results are expected.
Focus on customer service, with agility, clear communication and reaching goals.
Expected strong commitment and willingness to learn new disciplines, having to deal with varied responsibilities.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.