Senior Director, Process Development

Wheeler Bio•Oklahoma City, OK

About The Position

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.

Requirements

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

Responsibilities

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
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)
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
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
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