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CMC Project Manager - Biopharma
$111k-141k (estimate)
Full Time | Business Services 2 Months Ago
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KP Recruiting Group is Hiring a CMC Project Manager - Biopharma Near Boston, MA

KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world’s leading companies. Headquartered in the Midwest, KP Recruiting Group has successfully completed countless engagements across the United States. We represent clients in all industries and all sizes. Our mission is to provide exceptional client and candidate experiences in order to get the best possible results. On behalf of our client, we are excited to present the following confidential role. We look forward to hearing from you and discussing the opportunity!

The Role:

The CMC Project Manager will translate the CMC strategy for a given R&D project into a comprehensive operational plan, including risk assessment. The CMC PM leads the operational execution and oversees the planning, costs and resources in compliance with quality and regulatory requirements. This role will work closely with the CMC Project Lead(s) to develop and align on project plans, manage CMC project teams and timelines, escalate issues, and provide regular updates to stakeholders. The CMC PM is assigned to one or several projects, from pre-clinical up to submission and approval in the major markets.
Key Responsibilities
  • Develop integrated CMC project plans for assigned project(s) with the CMC Project Lead(s) and the CMC team
  • Ensure project plan alignment with portfolio priorities and capacity
  • Develop CMC planning scenario
  • Lead project risk assessment and associated mitigation plan
  • Define the project budget and track spending
  • Analyze, monitor and report on CMC project plan execution
  • Contribute to project documents and governance meetings preparation
  • Promote and ensure implementation of Good Project Management practices

Requirements

  • PhD in Biology, Biotechnology, Chemistry or related sciences discipline with a minimum of 8 years of relevant experience or a Masters degree with 11 years of relevant experience or a Bachelor's degree with 12 years of relevant experience
  • Experience leading cross functional project teams in a complex, international and multicultural environment
  • Expertise in Project Management
  • Knowledge in CMC development and/or R&D and Industrial Affairs
  • Experience in Gene Therapy and/or Cell Therapy and/or biopharmaceuticals derived from mammalian cell culture such as monoclonal antibodies, complex proteins and recombinant proteins
  • Strong negotiation skills
  • excellent communication skills, fluency in English
  • Ability to foster a strong collaborative spirit
  • Experience with Microsoft Office Suite (Excel, Word, PowerPoint), planning software (Microsoft Project, Thinkcell®, etc.) and flow diagrams
Preferred Qualifications
  • Certification in Project Management

Benefits

  • 401k Matching
  • Family and Individual Insurance Packages (Health, Life, Dental, and Vision)
  • Paid Time Off & Paid Holidays
  • Long & Short-Term Disability
  • Identity Theft Plans
  • Retirement & Pension Plans
  • Employee Assistance Program
  • Employee Referral Program
  • Tuition Reimbursement Programs
  • Advancement & Professional Growth opportunities 
  • Parental Leave
  • & More

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$111k-141k (estimate)

POST DATE

03/09/2024

EXPIRATION DATE

06/05/2024

WEBSITE

kprecruiting.com

HEADQUARTERS

Minneapolis, MN

SIZE

<25

INDUSTRY

Business Services

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