Director, Process & Analytical Development
$196,700–$232,650 year
RemoteUnited States
Job Summary
Lead, coach, and develop the Process & Analytical Development organization, ensuring safe, compliant, and on-time delivery of services and products aligned with strategic growth priorities. Define and execute the strategic direction through long-term planning, portfolio management, and resource allocation while establishing capabilities to support future manufacturing operations. Provide oversight for development and project-specific manufacturing activities, driving Lean maturity and operational excellence across the organization. Partner with R&D, Manufacturing, Engineering, Quality, and Supply Chain teams to ensure successful technology transfer and commercialization execution, while acting as a key stakeholder in new technology evaluation and implementation. Support site startup, facility expansion, and capital investment initiatives as required. This full-time role operates remotely with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m., with an anticipated transition to an on-site location on the U.S. East-Coast or Mid-West by 2027.
Required Qualifications
- Master's degree in engineering, Life Sciences, Chemistry, Pharmaceutical Sciences, or a related field
- 15+ years of progressive leadership experience within pharmaceutical, biotechnology, CDMO, or related life sciences environments
- Deep understanding of small molecule and bioconjugate technologies
- Extensive leadership experience within Process Development, Analytical Development, Technical Operations, Manufacturing, or related GMP-regulated organizations
- Strong understanding of pharmaceutical manufacturing operations, cGMP requirements, technology transfer, validation, operational readiness, and commercialization activities
- Demonstrated experience supporting facility startup, expansion projects, greenfield or brownfield investments, and large-scale capital programs
- Proven success leading organizations through growth, transformation, and operational scale-up initiatives
- Strong technical knowledge and experience in small molecule drug substance manufacturing
- Ability to influence and collaborate across Engineering, Quality, MSAT, Automation, Manufacturing, EHS, HR, Finance, and Commercial functions without relying solely on direct authority
- Demonstrated ability to translate business requirements into practical, scalable operational solutions
- Strong executive presence with the ability to communicate operational readiness, risks, business performance, and strategic recommendations to senior leadership and governance bodies
- Experience building organizations, developing talent, and preparing teams for future operational and business needs
- Strong understanding of Lean Manufacturing, Six Sigma, Operational Excellence, automation, digital systems, and data integrity principles
- Demonstrated capability in portfolio management, strategic planning, budget ownership, and resource allocation
- Ability to effectively navigate ambiguity, manage competing priorities, and lead within a fast-paced environment with multiple stakeholders
- Strong leadership, communication, problem-solving, and decision-making skills with a track record of delivering sustainable business results
- Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve
- Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives
Desired Qualifications
- PhD
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