Integrated Resources, Inc

2 weeks ago

waltham, United States Integrated Resources, Inc ( IRI ) Full time

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.

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