What are the responsibilities and job description for the CMC Operations Manager position at Integrated Resources, Inc ( IRI )?
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 Operations Lead 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, leadership, and support services to foster trust, facilitate solutions, on all assigned operations. They will facilitate efforts to overcome the obstacles and major roadblocks so scientists can succeed, while empowering them to function independently within the current operational workflows. They will review the scope of the various support services to identify gaps and solutions based on the requirements of the site. 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. Basic scientific understanding of the work performed within the GMU CMC and the associated consumables, software, equipment, and chemical requirements is an advantage.
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 form 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.
• 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.
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.
