Title: CMC Operations Lead/ Coordinator II

Location: Waltham, MA

Duration: 12+ months (Possibility of an extension)

Shift hours: Mon-Fri 8:00 am - 4:00 pm EST

Must have:

• 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.

Nice to Have:

• 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.

Specific 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.

Basic Qualifications:

• 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 from managing large capital projects/investments.
• Solid understanding of Health, Safety, Environmental and Legal requirements for operations.
• Clear operational experience in R&D and development laboratories.
• 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.

Preferred Qualifications:

• 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.