CMC Operation Lead
: Job Details :


CMC Operation Lead

Pyramid Consulting

Location: Waltham,MA, USA

Date: 2024-12-24T02:05:14Z

Job Description:

Immediate need for a talented CMC Operation Lead. This is a 12+months contract opportunity with long-term potential and is located in Waltham, MA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID:24-54068

Pay Range: $42 - $45/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key 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.

Key Requirements and Technology Experience:

  • Skills-Research and development , Operation , Health, Safety, Environmental.
  • 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.
  • 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.
  • 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 Client 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.
  • 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.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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