Immediate need for a talented CMC Operation Lead. This is a 12+months contract opportunity with long-term potential and is located in Waltham, MA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:24-54068
Pay Range: $42 - $45/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Lead by example to promote an inclusive, motivating work environment that encourages participation, creativity, learning, and accountability.
- Lead/support the champions teams for CMC and Research within GMU in Waltham.
- Support information sharing (via share site and meetings) between support functions and champions team & functions heads.
- Facilitate cross functional interactions within the 225 site and provide support between champion teams as required.
- Work with champions and functional leads to develop solutions for bottlenecks to enable science.
- Organize and relay feedback on managed services to various support functions to support adherence and compliance.
- Support project teams, functional heads, and departments on establishing internal workflows and operations.
- Collaborate with support functions such as HSE, Real Estate, Workspace Experience, Scientific services, etc. to support lab operations.
- Facilitate coordination of disruptive activities required by workplace experience, real estate, or other initiatives coordinate to ensure science continuation.
- Manage office and lab basic consumables including issuing PO's, tracking and invoice approvals, receiving, handling, & stocking.
Key Requirements and Technology Experience:
- Skills-Research and development , Operation , Health, Safety, Environmental.
- Minimum of 5 years of experience in research and development environment operations, R&D pharma operations experience.
- Experience in management experience, previous experience managing initiative or process.
- Solid understanding of basic safety principles, concepts and regulations.
- Understanding of operational experience in R&D and development laboratories, as well as their functions.
- CMC experience is not required, but helpful.
- Previous leadership experience is welcomed and would not be considered overqualified.
- Ability to process invoicing process and previous experience or similar software experience a plus: Concur, eBuy, EasyInvoice, and Workday.
- MS in Life Science discipline.
- Biologics/Pharmaceutical facility startup and management experience.
- In depth knowledge of biotechnology processes/concepts/techniques and principles.
- Technical knowledge of biologics manufacturing systems and processes.
- Excellent people leadership and change leadership skills.
- BS required in Life Science discipline or engineering.
- Minimum of 5 years of experience in research and development environment operations
- Minimum of 2 years of management experience.
- Experience working with GXP integrated commissioning and qualification practices.
- Experience working within a regulated environment.
- Experience with coordinating invasive operations form managing large Client projects/investments.
- Solid understanding of Health, Safety, Environmental and Legal requirements for operations.
- Clear operational experience in R&D and development laboratories.
- Excellent communication and technical writing skills.
- Demonstrated problem solving / trouble shooting skills.
- Direct experience working in regulated environments, i.e., cGMP, OSHA, EPA, etc.
- Proficiency with Microsoft Office Suite, working knowledge of common intranet communication tools and business tools such as Concur, eBuy, EasyInvoice, and Workday.
- MS in Life Science discipline.
- Biologics/Pharmaceutical facility startup and management experience.
- In depth knowledge of biotechnology processes/concepts/techniques and principles.
- Technical knowledge of biologics manufacturing systems and processes.
- Excellent people leadership and change leadership skills.
- Special Working Conditions-Ability to gown and gain entry to laboratory, manufacturing, and mechanical areas.
- Ability to handle materials, receive deliveries, push or operate pallet jacks according to HSE requirement.
Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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