Sr. Client Facing CMC Program Manager

Avid Bioservices
Onsite

About The Position

The Sr. Client Facing CMC Program Manager is a strategic leader responsible for overseeing complex, high value drug substance (DS) CMC programs within a CDMO environment. This role serves as the senior day-to-day partner for external clients, accountable for execution against contractual commitments while shaping delivery strategy, risk posture, and long-term client relationships across early and late phase biologics programs. As a senior representative of the organization, this role balances client advocacy, operational reality, and enterprise priorities, driving predictable outcomes, trusted partnerships, and sustainable company growth.

Requirements

  • Bachelor’s degree in a scientific or engineering discipline (advanced degree preferred)
  • 7–10+ years of experience in biotechnology or pharmaceutical CMC program or project management
  • Demonstrated leadership of drug substance CMC programs across development phases
  • Experience operating in a CDMO or client service delivery model with external accountability
  • Strong understanding of GMP manufacturing, validation, regulatory expectations, and commercialization readiness
  • Proven ability to influence senior client and internal stakeholders
  • Advanced proficiency with scheduling and program management tools (e.g., Smartsheet, MS Project)
  • A confident senior leader comfortable representing the organization with external clients
  • Skilled at navigating ambiguity, tradeoffs, and high stakes decision making to drive program results
  • Strategic, solutions-oriented, and commercially aware
  • Able to mentor others while maintaining hands on accountability where needed
  • Motivated by building trusted partnerships and delivering consistent, high-quality outcomes

Responsibilities

  • Serve as the senior program lead and primary escalation point for assigned DS CMC client programs
  • Own the overall client relationship post contract, ensuring delivery aligns with scope, timelines, financial commitments, and quality standards
  • Lead executive level client governance, including program reviews, risk discussions, and long-range planning
  • Build credibility as a strategic thought partner, providing forward looking recommendations and scenario-based options
  • Partner closely with Business Development on program transitions from pursuit to execution, scope expansion, amendments, and future phase planning, and long term account and portfolio strategy
  • Provide program leadership across end-to-end drug substance CMC activities, including process development strategy and lifecycle planning, technology transfer from client or internal development into GMP operations, scale up strategy and manufacturing execution, GMP DS manufacturing oversight, process validation, PPQ, and commercialization readiness
  • Define and drive phase appropriate execution strategies: Early phase: flexibility, assumption management, and speed to data; Late phase: schedule discipline, risk containment, and supply assurance
  • Ensure integrated execution plans reflect client intent, regulatory strategy, and internal capacity
  • Act as the senior integrator across Process Development, Manufacturing, Quality, Supply Chain, Regulatory, and external partners
  • Lead alignment on priorities, resourcing, and tradeoffs for complex or high-risk programs
  • Facilitate critical decision-making forums where quality, schedule, cost, and capacity must be balanced
  • Drive disciplined governance, escalation, and resolution of cross functional conflicts
  • Coach functional and program teams on client centric execution and accountability
  • Own program level risk strategy for technical, operational, regulatory, and schedule exposure
  • Lead proactive mitigation planning and transparent escalation with executive stakeholders and clients
  • Oversee change control for scope, timeline, and cost, ensuring clear impact analysis, client alignment and documentation, and protection of company and client interests
  • Maintain strong financial awareness, including budget oversight, forecasting, and margin considerations
  • Contribute to portfolio level prioritization, capacity planning, and governance discussions
  • Serve as a mentor and escalation resource for mid-level CMC program managers
  • Support development and refinement of CDMO CMC program management standards, tools, and best practices
  • Represent Program Management and CMC execution perspectives in internal leadership forums

Benefits

  • health, dental, and vision insurance
  • 401(k) matching
  • paid time off
  • performance-based bonuses
  • opportunities for career growth and development
  • supportive and inclusive work environment
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