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Pharmaceutical Product Development
Pharmaceutical Product Development

60 Ppd Jobs Hiring Near You

Comptech Associates Inc.

Biotechnology / Pharmaceutical Client: Global Clinical-Stage Biopharmaceutical Company * Our client is seeking a highly experienced CMC Product Development Strategy Consultant to lead the design and ...

Cardinal Health

Manager, Product Development

Indianapolis, IN · On-site

$109K - $136K/yr

Demonstrated experience in the operation, use, and maintenance of pharmaceutical production and ... product development. * Experience working with contract manufacturing as well as working with ...

The International Society for Pharmaceutical Engineering, Inc.

$160 - $260/hr

Team Leadership & Development * Partner with and direct teams of one to three Senior Managers and analysts per initiative; scope work realistically against team capacity and deliver high-quality ...

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Senior CMC Product Development Strategy Consultant

Comptech Associates Inc.

Remote

Contractor

Posted 10 days ago

Job description

Job Title: Senior CMC Product Development Strategy Consultant
Location: Primarily Remote (U.S.) with occasional onsite workshops as needed
Duration: 6 Months
No. of Positions: 1
Industry: Biotechnology / Pharmaceutical
Client: Global Clinical-Stage Biopharmaceutical Company
JOB DESCRIPTION
  • Our client is seeking a highly experienced CMC Product Development Strategy Consultant to lead the design and development of an enterprise Product Development Roadmap (PDR), a comprehensive governance playbook that standardizes product development activities from pre-clinical development through Phase III and Marketing Application readiness.
  • Working closely with senior CMC leadership, the consultant will create a scalable framework that defines development stages, governance, key deliverables, decision points, and cross-functional responsibilities.
  • The resulting playbook will become the standard methodology used across all development programs, improving consistency, transparency, execution quality, and organizational readiness.
  • This role is ideal for a former pharmaceutical executive or senior consultant with extensive experience leading global CMC development organizations and designing stage-gate governance models.
Primary Responsibilities
  • Lead the design of a comprehensive Product Development Roadmap (PDR) framework spanning:
    • Discovery transition
    • Preclinical Development
    • IND Readiness
    • Phase I
    • Phase II
    • Phase III
    • Marketing Application Readiness
    • Commercial Launch Readiness
  • Develop an enterprise playbook defining:
    • Stage gates
    • Governance model
    • Key activities
    • Required deliverables
    • Decision criteria
    • Milestones
    • Success measures
  • Define cross-functional responsibilities across:
    • CMC
    • Pharmaceutical Development
    • Analytical Development
    • Manufacturing
    • Quality
    • Regulatory Affairs
    • Clinical Supply
    • Technical Operations
    • Program Management
  • Facilitate workshops with senior leadership to gain alignment on the roadmap structure and governance approach.
  • Identify best practices from leading pharmaceutical development organizations.
  • Establish standardized templates, governance processes, and repeatable workflows.
  • Ensure the roadmap is scalable across multiple development programs and therapeutic assets.
  • Support implementation planning and organizational adoption.
Required Experience
  • 15+ years of progressive pharmaceutical or biotechnology experience.
  • Significant leadership experience within:
    • CMC Development
    • Pharmaceutical Development
    • Technical Operations
    • Product Development
    • Program Leadership
  • Experience supporting products from early development through regulatory submission.
  • Demonstrated experience building:
    • Stage-gate processes
    • Product development frameworks
    • Governance models
    • Development of playbooks
  • Strong understanding of:
    • CMC development lifecycle
    • IND-enabling activities
    • Clinical development
    • Regulatory submission requirements
    • Commercial readiness
Experience facilitating executive workshops and achieving cross-functional alignment.
Preferred Qualifications
  • Former Director, Senior Director, Executive Director, or Vice President within:
    • CMC
    • Pharmaceutical Development
    • Technical Operations
    • Product Development
    • Program Management
  • Consulting experience with McKinsey, BCG, Bain, Client, PwC, Client, or a specialized life sciences consulting firm is highly desirable.
  • Experience developing governance frameworks used across multiple development programs.
  • Background supporting biologics, small molecules, gene therapy, or other advanced therapeutic modalities.
Experience within fast-growing biotechnology organizations is preferred.
Core Competencies
  • Pharmaceutical Product Development
  • CMC Strategy
  • Stage-Gate Governance
  • Cross-Functional Leadership
  • Executive Facilitation
  • Process Design
  • Program Management
  • Organizational Change Management
  • Risk Management
  • Regulatory Strategy
  • Strategic Planning
  • Executive Communications
Deliverables
The consultant will be responsible for developing:
  • Enterprise Product Development Roadmap (PDR)
  • Product Development Playbook
  • Stage-Gate Governance Framework
  • Development Lifecycle Framework
  • Cross-Functional RACI Matrix
  • Key Deliverables Matrix
  • Milestone and Decision Framework
  • Governance Charter
  • Executive Steering Committee Framework
  • Standard Templates and Tools
  • Executive Presentation Materials
  • Implementation & Adoption Roadmap
Success Measures
Success will be measured by the consultant's ability to:
  • Develop a standardized, repeatable Product Development Roadmap adopted across all development programs.
  • Establish clear governance, stage gates, and decision-making processes.
  • Improve cross-functional alignment and accountability throughout the development lifecycle.
  • Reduce ambiguity by defining standardized deliverables and milestone expectations.
  • Enable consistent planning and execution from preclinical development through marketing application readiness.
Ideal Candidate Profile
  • The ideal consultant is a respected pharmaceutical development leader who has successfully guided multiple products through the development lifecycle while building scalable development processes.
  • They combine strategic thinking with operational execution and are skilled at facilitating executive alignment across complex, matrixed organizations.
  • Their experience allows them to translate industry's best practices into practical governance frameworks that improve execution, accelerate decision-making, and support long-term portfolio growth.

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