Sr. Director, Head of Process Engineering

Job Description

OBJECTIVE:

Synthetic Molecule Process Development (SMPD) is responsible for developing robust, sustainable, and cost-effective processes for the manufacture of new synthetic molecule pharmaceuticals, ensuring high standards of quality, safety, and scalability.

ACCOUNTABILITIES:

• Defines the long-term vision and strategic roadmap for SMPD global process engineering capabilities, ensuring alignment across SMPD departments and Pharm Sci functions, as well as other business units (Quality, Regulatory, GSQ).

• Accountable for the performance and results of global team, including performance management, talent development, succession planning, and building organizational capability across global regions.

• Accountable for development and manufacturing of full synthetic molecule development in terms of leveraging process engineering expertise either directly or through leadership of team member(s).

• Establishes and manages operational processes across global Process Engineering within global SMPD.

• Has full accountability for all engineering aspects for small molecule pipeline projects.

• Directs team members in process development and optimization for key unit operations, including reaction engineering, crystallization, particle engineering, separations, and drying.

• Oversees design, qualification, and operation of laboratory scale-down models to enable robust process scale-up.

• Develops and oversees strategies for global Process Engineering infrastructure, resources, projects, etc. and implements relevant technologies and innovations.

• Manages performance, personnel issues, and communication effectiveness within global Process Engineering.

• Accountable for the development of organizational culture and capabilities within global Process Engineering and global SMPD.

• Defines and owns sourcing strategy for process engineering development and contributes materially and may own aspects of overall strategy for synthetic molecule development and manufacture.

• Contributes to wider cross Business Unit strategy particularly with respect to Commercial (GSQ) development and manufacturing.

• Engages frequently with leadership of SMPD departments and Pharm sci functions, and other business units (Quality, Regulatory, and GSQ) to ensure investigational synthetic molecule engineering strategies are aligned at the operational workflow, Project, and Portfolio levels, where relevant.

• Identifies and elevates awareness of topics for initiatives with impact across R&D/cross-divisional organization.

• Leads complex, interdisciplinary initiatives and may sponsor a cross-departmental or cross-functional initiatives.

• Advises CMC teams on impact of team actions on other projects in their functional area and vice versa.

• Utilizes technical expertise to contribute to R&D/cross-Business Unit strategy to solve complex issues.

• Accountable for relevant technical content in regulatory filings (IND, NDA, MAA) and health authority queries.

• Establishes and enforces best practices in process safety, quality by design (QbD), and risk management.

• Builds and sustains strategic relationships with academic partners, consortia, and vendors to access cutting-edge science and capabilities.

• Maintains external visibility and thought leadership through publications, invited talks, and representation in industry working groups.

EDUCATION,

EXPERIENCE AND SKILLS:

• Bachelor’s degree in Chemical Engineering and 25+ years relevant industry experience;
  Master’s degree in Chemical Engineering and 21+ years relevant industry experience;
  PhD in Chemical Engineering and 15+ years relevant industry experience.

• Extensive experience in small molecule process development, scale-up, and commercialization.

• Direct experience working in a manufacturing facility or pilot plant environment, with a strong understanding of cGMP operations, technology transfer, and scale-up.

• Demonstrated leadership in facility design, start-up, or expansion projects, including defining user requirements, equipment selection, and commissioning.

• Demonstrated success in leading teams and managing technical staff.

• Strong track record of contributions to regulatory filings (IND/IMPD, NDA, MAA), including late-stage submissions.

• Significant experience in working with external partners (CMOs/CDMOs) and managing complex technology transfers.

• Expertise in process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.), chemometrics, and modeling (statistical and first principles).

• Experience with advanced process control strategies and continuous…