Director, Process Development Job Listing at Kelly Services in Winston Salem, NC (Job ID US3589779_BH9916069)

Description

Director, Process Development – Cell Therapy

Work Schedule and Compensation:

• Full-time, onsite schedule: Monday-Friday, 8:00 AM to 5:00 PM
• Salary range: $190,000 to $220,000 annually
• ??????Bonus potential: Up to 20% of base salary
• ??????Relocation assistance available

Position Summary:
An established biopharmaceutical organization is seeking an experienced scientific leader to serve as Director of Cell Therapy Process Development. This pivotal role offers a unique opportunity to lead the advancement and optimization of a robust, commercial-scale manufacturing process for a cell therapy product currently in late-stage clinical development. The successful candidate will provide strategic and operational leadership to drive manufacturing process development, critical process parameter identification, technology transfer, validation activities, and regulatory submission preparation. Strong collaboration with internal stakeholders and external partners is essential, as is fostering a diverse, inclusive culture and prioritizing the growth and development of a high-performing team.

Key Responsibilities:

• Lead development and optimization of manufacturing processes for a cell therapy product, ensuring robustness and reproducibility. Oversee technology transfer activities between R&D and commercial manufacturing.

• Drive process improvement initiatives focused on enhancing productivity, yield, and product quality through adoption of advanced manufacturing technologies.

• Plan and execute process validation and qualification studies to meet regulatory and quality standards. Develop control strategies for critical process parameters (CPPs) to ensure consistent product performance.

• Build, mentor, and manage a multidisciplinary team of scientists, engineers, and technical professionals dedicated to process development. Promote a culture of innovation, collaboration, and continuous learning.

• Collaborate closely with quality, regulatory, clinical, and manufacturing functions to ensure alignment and effective execution of development activities.

• Lead preparation and review of technical documentation supporting regulatory filings, including IND and BLA submissions.

• Identify and mitigate technical, operational, and regulatory risks associated with process development. Implement risk management strategies proactively.

• Define and execute strategic goals and milestones for the process development function, aligning with broader organizational objectives.

• Establish and monitor KPIs to evaluate process efficiency and team performance, providing regular updates and data-driven insights to senior leadership.

Qualifications:

• PhD in Biochemistry, Chemical Engineering, Biotechnology, or related discipline preferred; MS with extensive relevant experience will be considered.

• At least 12 years of industry experience in bioprocess development, including a minimum of 8 years in leadership roles within biopharmaceutical manufacturing, with a preference for cell therapy expertise.

• Deep knowledge of cell culture and cell therapy manufacturing processes, bioprocess modeling, data analytics, and automation technologies.

• Proficiency with process risk assessment and quality methodologies, such as FMEA, Quality by Design (QbD), Design of Experiments (DoE), and statistical software (e.g., JMP).

• Comprehensive understanding of regulatory requirements from FDA, EMA, and ICH guidelines relevant to biologics and cell therapies, with experience preparing IND and BLA submissions.

• Familiarity with analytical techniques including flow cytometry, ELISA, and potency assays supporting process development and product release.

• Proven project management skills, capable of managing multiple projects, budgets, and resource allocation efficiently.

• Strong leadership abilities with demonstrated success building and leading cross-functional teams in dynamic environments.

• Excellent communication skills, adept at conveying complex technical information to diverse audiences.

• Experience working with cell-based therapies or personalized medicine products highly desirable.

• Knowledge of process control systems, automation, and data-driven process monitoring and optimization.

• Experience contributing to regulatory filings and CMC documentation for global submissions.

• Comfortable operating in fast-paced, high-growth, or startup-like environments, driving innovation and adapting to evolving challenges.
  
  
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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