CMC Operations Lead

2 weeks ago

Waltham, United States The Fountain Group Full time

Currently I have an opening for a CMC Operations Lead located in Waltham, MA. Details for the position are as follows:

Job Description:

  • 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.
  • 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.
  • 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.
  • Bachelor’s degree required, masters preferred, with 5+ years of experience in R&D operations, management experience, and CMC.

Technical Information:

  • 12-month contract with potential for extension or conversion
  • Onsite, M-F, 8am-5pm
  • Pay: $40-48 hourly, depending on experience level

  • The Fountain Group | CMC Operations Lead

    2 weeks ago

    waltham, United States The Fountain Group Full time

    Currently I have an opening for a CMC Operations Lead located in Waltham, MA. Details for the position are as follows:Job Description: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...

  • CMC Operation Lead

    5 days ago

    Waltham, United States Pyramid Consulting, Inc Full time

    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,...

  • CMC Operation Lead

    2 weeks ago

    Waltham, United States Pyramid Consulting, Inc Full time

    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,...

  • CMC Operations Coordinator

    5 days ago

    Waltham, United States LHH Full time

    Job Title: GMU CMC Operations LeadLocation: Waltham, MA (Local candidates only; Fully Onsite)Department: Genomic Medicine Unit (GMU) CMC, SanofiAbout Us:The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is at the forefront of innovation, responsible for drug development from molecule/pre-candidate to product approval....

  • CMC Operations Coordinator

    2 weeks ago

    Waltham, United States LHH Full time

    Job Title: GMU CMC Operations LeadLocation: Waltham, MA (Local candidates only; Fully Onsite)Department: Genomic Medicine Unit (GMU) CMC, SanofiAbout Us:The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is at the forefront of innovation, responsible for drug development from molecule/pre-candidate to product approval....

  • CMC Operations Manager

    5 days ago

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

    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...

  • CMC Operations Manager

    5 days ago

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

    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...

  • LHH | CMC Operations Coordinator

    2 weeks ago

    waltham, United States LHH Full time

    Job Title: GMU CMC Operations LeadLocation: Waltham, MA (Local candidates only; Fully Onsite)Department: Genomic Medicine Unit (GMU) CMC, SanofiAbout Us:The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is at the forefront of innovation, responsible for drug development from molecule/pre-candidate to product approval....

  • LHH | CMC Operations Coordinator

    2 weeks ago

    waltham, United States LHH Full time

    Job Title: GMU CMC Operations LeadLocation: Waltham, MA (Local candidates only; Fully Onsite)Department: Genomic Medicine Unit (GMU) CMC, SanofiAbout Us:The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is at the forefront of innovation, responsible for drug development from molecule/pre-candidate to product approval....

  • Director, CMC

    3 weeks ago

    Waltham, United States Mythic Therapeutics, Inc. Full time

    Sr. Director/Director, CMCCompany Overview:Mythic Therapeutics is a privately held, clinical stage product-platform company building a pipeline of best-in-class antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Company’s FateControl engineering technology dramatically enhances ADC uptake in tumor...

  • Director, CMC

    3 weeks ago

    Waltham, United States Mythic Therapeutics, Inc. Full time

    Sr. Director/Director, CMCCompany Overview:Mythic Therapeutics is a privately held, clinical stage product-platform company building a pipeline of best-in-class antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Company’s FateControl engineering technology dramatically enhances ADC uptake in tumor...

  • Operations Lead

    5 days ago

    Waltham, United States TalentBurst, an Inc 5000 company Full time

    Job Title: Coordinator IILocation: Waltham, MADepartment: Genomic Medicine Unit CMCAbout 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...

  • Operations Lead

    6 days ago

    Waltham, United States TalentBurst, an Inc 5000 company Full time

    Job Title: Coordinator IILocation: Waltham, MADepartment: Genomic Medicine Unit CMCAbout 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...

  • CMC Project Manager

    1 month ago

    Waltham, United States Upstream Bio Full time

    Position Summary:The CMC Project Manager will support Technical Operations for Upstream Bio’s verekitug program. Responsibilities include supporting the team to advance the program to meet major milestones, and coordination and operational support of manufacturing and analytical activities conducted at CDMOs. Additionally, this role will interact with...

  • CMC Project Manager

    1 month ago

    Waltham, United States Upstream Bio Full time

    Position Summary:The CMC Project Manager will support Technical Operations for Upstream Bio’s verekitug program. Responsibilities include supporting the team to advance the program to meet major milestones, and coordination and operational support of manufacturing and analytical activities conducted at CDMOs. Additionally, this role will interact with...

  • CMC Marketing Professional

    3 weeks ago

    Waltham, Massachusetts, United States Pharmaron Full time

    Job SummaryCraft compelling narratives, lead marketing campaigns, collaborate with scientists, and represent our brand as a Scientific Marketing Manager/Director at Pharmaron. We're seeking an experienced professional with 8+ years in small molecule CMC to help elevate our brand and drive sales.About the RoleWe're looking for a seasoned scientist with a...

  • CMC Project Coordinator

    5 days ago

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

    Title: CMC Operations Lead/ Coordinator IILocation: Waltham, MADuration: 12+ months (Possibility of an extension)Shift hours: Mon-Fri 8:00 am - 4:00 pm ESTMust 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...

  • CMC Project Coordinator

    2 weeks ago

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

    Title: CMC Operations Lead/ Coordinator IILocation: Waltham, MADuration: 12+ months (Possibility of an extension)Shift hours: Mon-Fri 8:00 am - 4:00 pm ESTMust 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...

  • Upstream Bio | CMC Project Manager | waltham, ma

    1 month ago

    waltham, United States Upstream Bio Full time

    Position Summary:The CMC Project Manager will support Technical Operations for Upstream Bio’s verekitug program. Responsibilities include supporting the team to advance the program to meet major milestones, and coordination and operational support of manufacturing and analytical activities conducted at CDMOs. Additionally, this role will interact with...

  • Upstream Bio | CMC Project Manager | waltham, ma

    1 month ago

    waltham, United States Upstream Bio Full time

    Position Summary:The CMC Project Manager will support Technical Operations for Upstream Bio’s verekitug program. Responsibilities include supporting the team to advance the program to meet major milestones, and coordination and operational support of manufacturing and analytical activities conducted at CDMOs. Additionally, this role will interact with...