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Senior Consultant / Director, CMC

Latham BioPharm Group Cambridge, MA
  • Posted: over a month ago
  • Full-Time
  • Benefits: 401k, life_insurance, medical
Job Description

Title: Senior Consultant / Director, CMC

Position Reference: 2020003

Primary Location: Flexible, ideally Eastern US

Travel: Significant travel required to client sites (primarily Eastern US)

Key Role:

Provide consulting services and leadership for Latham’s clients and employees including, but not limited to technology transfer oversight and management of government and commercially funded technology and product development programs.

Job Duties:

Provide subject matter expert consulting services to clients including:

  • GMP Tech transfer technical activities (vaccine drug product and drug substance)
  • GMP Tech transfer process implementation and continuous improvement
  • General CMC implementation for vaccines and biologics

Identify, establish and manage client relationships

  • Collaborate with client leadership and technical professionals in planning, staffing, and executing GMP-compliant vaccine tech transfer projects
  • Provide strategic and tactical facilitation to client leadership in major cross-functional tech transfer decision events and deliverables, such as Stage Gate Reviews
  • Develop and present recommendations to client leadership regarding development issues and risks for vaccine tech transfer projects, as well as ways to accelerate tech transfer projects and facilitation

Provide leadership in vaccine tech transfer project delivery teams

  • Lead team preparation and presentation of major tech transfer activities and deliverables, such as Stage Gate Reviews
  • Provide leadership in creating standard tech transfer process playbooks
  • Provide team guidance, expert advice, counsel, and leadership in planning, staffing, and executing GMP-compliant vaccine tech transfer projects in accord with standard tech transfer process playbook
  • Monitor and manage the total end to end tech transfer project
  • Lead troubleshooting, solution development, and corrective action to keep vaccine tech transfer on plan and on schedule
  • Provide actionable feedback for individual project team members

Support the growth of the company and sale of new engagements.

Basic Requirements:

10+ years’ experience with:

  • Direct experience in technology transfers for vaccine drug product from both the sending and receiving site
  • Technology transfer to or from CDMOs
  • Technology transfer to or from large pharma
  • Drug substance
  • Direct experience in biologics process development and/or manufacturing
  • Experience in management
  • Experience in business development a significant plus
  • Experience with a service provider (CDMO/Consulting) a significant plus
  • Experience in program management a significant plus
  • Microsoft suite proficiency

Undergraduate degree in a related field

Additional Desirable Capabilities:

  • Experience in business development
  • Strong communications and leadership skills
  • Strong presence and reputation in the industry
  • Advanced degree in a related field

Latham BioPharm Group, Inc offers a competitive base salary, annual bonus, professional career development and growth opportunities, medical, life, short and long-term disability, and Safe Harbor 401K plan options with 3% automatic contribution and up to 5% corporate match.

Company Description
Latham BioPharm Group (LBG) unites teams and technologies in the Life Sciences. We provide high level life science product development support, strategic consulting services and nondilutive funding support.

Latham BioPharm Group

Why Work Here?

Growing consulting company focused on making a positive difference in the world.

Latham BioPharm Group (LBG) unites teams and technologies in the Life Sciences. We provide high level life science product development support, strategic consulting services and nondilutive funding support.

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