Senior Director, Process Development

Position Summary

The Senior Director of Process Development is a senior technical and people leader responsible for the strategic oversight, execution, and continuous improvement of upstream, downstream, and cell line development activities in support of client-sponsored programs and internal technology platforms. This role ensures robust, scalable, and compliant processes that enable successful technology transfer into GMP manufacturing and support regulatory filings across preclinical through commercial stages.

The position serves as a key interface between clients, manufacturing, quality, regulatory, and business development, playing a critical role in maintaining the Wheeler Bio’s technical excellence, operational readiness, and client satisfaction.

Key Responsibilities

Strategic & Technical Leadership:

• Define and execute process development strategy aligned with company growth objectives and client portfolio needs
• Oversee development of scalable, robust, and cost-effective processes for biologics and/or advanced therapeutics (e.g., monoclonal antibodies, multi-specific antibodies, recombinant proteins)
• Ensure scientific rigor and data integrity across all development activities
• Stay current with emerging technologies, regulatory guidance, and industry trends to maintain competitive advantage

Program & Client Management:

• Serve as senior technical lead and escalation point for client programs
• Provide expert guidance during client engagements, proposal development, and technical due diligence
• Ensure development timelines, budgets, and deliverables meet client and internal expectations
• Support technical sections of regulatory submissions (INDs, IMPDs, BLAs, MAAs)

Operational Excellence & Technology Transfer:

• Drive seamless technology transfer from development to GMP manufacturing
• Partner closely with Manufacturing, Quality, Supply Chain, and MSAT to ensure process robustness and readiness
• Establish phase-appropriate and risk-based development approaches and control strategies

People & Organizational Leadership:

• Lead, mentor, and develop a multidisciplinary team of scientists and managers
• Build a high-performing, collaborative culture focused on accountability and continuous improvement
• Support workforce planning, hiring, and talent development initiatives
• Establish clear performance expectations and career development pathways

Cross-Functional Collaboration:

• Collaborate with Business Development on proposals, technical assessments, and client onboarding
• Partner with R&D, MSAT, Manufacturing, Quality, Regulatory Affairs, and Supply Chain to ensure integrated execution
• Provide executive-level technical input to leadership teams and governance bodies

Required Qualifications

Education:

Master’s degree or above in Chemical Engineering, Biochemistry, Biotechnology, Chemistry, or related discipline

Experience:

• 12 years of progressive experience in biopharmaceutical process development, with direct experience in a CDMO regulated manufacturing environment
• Proven leadership experience managing scientific teams and complex client programs, as well as experience in client-facing leadership roles
• Demonstrated success developing and scaling processes from early development through commercialization
• Experience supporting regulatory filings and health authority interactions

Technical Expertise:

• Deep knowledge of mammalian upstream and/or downstream process development for biologics or advanced therapies
• Strong understanding of GMP manufacturing, process scale-up, and tech transfer
• Experience in establishing and maintaining platform processes
• Familiarity with analytical development, characterization, and control strategies
• Experience applying QbD, DoE, and risk management tools

Key Competencies:

• Strategic thinking and decision-making
• Strong leadership, communication, and influencing skills
• Client-centric mindset
• Scientific rigor and problem-solving ability
• Ability to operate effectively in a fast-paced, deadline-driven environment