VS-R&D Operations Lead - Waltham MA at Rangam Infotech Private Limited

Local candidates only Fully ONSITE role

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.

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.