R&D Operations Lead in Waltham, MA

  • Title: R&D Operations Lead
  • Code: RCI-9432
  • RequirementID: 123530
  • Location: Waltham, MA 02451
  • Posted Date: 12/23/2024
  • Duration: 12 Months
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  Job Description

Description:
 
About the department:
The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval. This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. Our mission is to serve patients through innovation in drug development and by designing state of the art manufacturing processes.
 
 
About the job:
GMU CMC Operation role will provides holistic support into the operational needs of the CMC organization to simplify workflows and enable scientists to achieve their deliverables. This position will be located in Waltham, MA. This role will build and maintain relationships with scientific staff, lab champions, functional heads, and support services to foster trust, facilitate solutions, on all assigned operations. They would employ excellent people management and communication skills to interact with all levels and functions at the 225 Waltham site. They would display creative problem-solving techniques to accommodate a dynamic environment. They would have basic scientific understanding of the work performed within the GMU CMC and the associated consumables, software, equipment, and chemical requirements is an advantage.
 
 
Primary Responsibilities:
• Lead by example to promote an inclusive, motivating work environment that encourages participation, creativity, learning, and accountability.
• Manage office and lab basic consumables including issuing PO’s, tracking and invoice approvals, receiving, handling, & stocking.
 
Secondary Responsibilities:
• 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.
• Support champions and functional leads to develop solutions for bottlenecks to enable science.
• 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.
 
 
Basic Qualifications
• BS required in Life Science discipline or engineering.
• Minimum of 3 years of operational experience in research and development environment
• Minimum of 2 years of management experience.
• Experience working with GXP integrated commissioning and qualification practices.
• Experience working within a regulated environment.
• Experience in material and consumable management.
• Experience with coordinating invasive operation activities of large capital projects/investments with lab operations.
• 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.
• 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.
• Participating in Biologics/Pharmaceutical facility startup and management experience.
• Technical knowledge of biologics manufacturing, research and development systems and processes.
• Excellent people 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.


About Rangam:

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