Role Overview for Director of Process Engineering (Bio)
JRG Partners is exclusively partnering with a pioneering biopharmaceutical company dedicated to developing life-changing therapies. We are seeking an exceptional and visionary Director of Process Engineering (Bio) to join our client’s dynamic team in Boston, MA. This pivotal leadership role demands a seasoned expert who can drive innovation, optimize bioprocesses from early-stage development through commercial manufacturing, and ensure the highest standards of quality and efficiency.
As the Director of Process Engineering (Bio), you will be at the forefront of shaping our client’s manufacturing capabilities. You will lead a talented team of engineers and scientists, providing strategic direction and technical oversight for all process engineering activities related to biologics manufacturing. This includes the design, development, scale-up, and optimization of upstream and downstream processes for various therapeutic modalities. Your expertise will be critical in translating scientific discoveries into robust, scalable, and cost-effective manufacturing processes, ultimately contributing to the delivery of critical medicines to patients worldwide.
This is more than just a technical role; it’s an opportunity to be a strategic leader, mentor, and innovator. You will champion continuous improvement initiatives, implement cutting-edge technologies, and foster a culture of excellence and collaboration within the organization. If you are passionate about biopharmaceutical manufacturing, possess a deep understanding of process engineering principles, and thrive in a fast-paced, high-impact environment, we invite you to explore this unique opportunity.
Our client offers a stimulating work environment where scientific curiosity, technical rigor, and patient-centricity are paramount. You will collaborate closely with R&D, Manufacturing, Quality Assurance, Regulatory Affairs, and other cross-functional teams to ensure seamless execution of projects and successful product development. This role provides significant autonomy and the chance to leave a lasting impact on the company’s trajectory and the lives of countless individuals.
Key Responsibilities of Director of Process Engineering (Bio)
Strategic Leadership & Direction
Provide visionary leadership and strategic direction for all biopharmaceutical process engineering activities, aligning with company goals and long-term manufacturing strategy.
Process Development & Optimization
Oversee the design, development, optimization, and characterization of robust, scalable, and cost-effective upstream (cell culture, fermentation) and downstream (purification, filtration) bioprocesses for biologics.
Scale-Up & Technology Transfer
Lead successful scale-up activities from lab to pilot and commercial scales, ensuring seamless technology transfer to internal manufacturing sites or external CDMO partners.
Team Management & Development
Recruit, mentor, develop, and manage a high-performing team of process engineers and scientists, fostering a collaborative and innovative work environment.
Regulatory Compliance
Ensure all process engineering activities and developed processes comply with current Good Manufacturing Practices (GMP), FDA, EMA, ICH guidelines, and other relevant regulatory requirements.
Process Validation
Direct and oversee process validation efforts, including authoring and reviewing validation protocols and reports (e.g., PPQ, cleaning validation).
Continuous Improvement
Drive continuous improvement initiatives using Lean, Six Sigma, and other operational excellence methodologies to enhance process efficiency, reduce costs, and improve product quality.
Cross-Functional Collaboration
Collaborate extensively with R&D, Manufacturing Operations, Quality Assurance, Regulatory Affairs, Analytical Development, and Project Management teams to ensure integrated project execution.
Risk Assessment & Mitigation
Implement robust risk assessment strategies (e.g., FMEA) for process development and manufacturing, developing and executing mitigation plans.
Budget & Resource Management
Manage departmental budgets, allocate resources effectively, and make informed decisions regarding capital expenditures and operational expenses.
New Technology Evaluation
Identify, evaluate, and implement innovative process technologies and equipment to enhance manufacturing capabilities and efficiency.
Documentation & Reporting
Ensure meticulous documentation of all process development, characterization, and validation activities, and prepare comprehensive technical reports and presentations for various stakeholders.
Troubleshooting & Problem Solving
Provide expert technical guidance and lead troubleshooting efforts for complex process-related issues during development, scale-up, and routine manufacturing.
Requirements for the Director of Process Engineering (Bio)
Education
Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related scientific discipline is highly preferred. A Master’s or Bachelor’s degree with extensive relevant experience will also be considered.
Experience
A minimum of 12-15 years of progressive experience in process development and engineering within the biopharmaceutical industry, with at least 5-7 years in a senior leadership or management role overseeing a team of engineers and scientists.
Biologics Expertise
Deep and comprehensive understanding of biologics manufacturing processes, including upstream (cell culture, fermentation, cell line development) and downstream (chromatography, filtration, UF/DF, viral inactivation/removal) operations.
Regulatory Knowledge
Expert-level knowledge of cGMP regulations, FDA, EMA, and ICH guidelines pertaining to biopharmaceutical manufacturing and process validation. Experience with regulatory submissions (IND, BLA) is a significant advantage.
Leadership & Management Skills
Proven ability to build, lead, mentor, and develop high-performing technical teams. Strong interpersonal skills with the ability to influence and collaborate effectively across all levels of an organization.
Process Characterization & Modeling
Strong experience with process characterization techniques, DoE (Design of Experiments), statistical analysis, and process modeling tools.
Analytical & Problem-Solving Skills
Exceptional analytical, critical thinking, and problem-solving abilities, with a track record of resolving complex technical challenges.
Communication
Excellent written and verbal communication skills, with the ability to present complex technical information clearly and concisely to diverse audiences, including senior management and external partners.
Project Management
Demonstrated project management skills, including the ability to manage multiple projects simultaneously, prioritize tasks, and meet challenging deadlines.
Quality Systems
Familiarity with quality management systems and their application in a GMP environment.
Innovation Mindset
A proactive and innovative mindset, continuously seeking opportunities for process improvement and technological advancement.
Travel
Ability to travel occasionally for technical conferences, vendor visits, or collaborations with external partners as required.
Benefits & Perks Offered
Our client understands the importance of attracting and retaining top talent. They offer a comprehensive and highly competitive benefits package designed to support the well-being and professional growth of their employees. As a Director of Process Engineering (Bio), you can expect:
Competitive Compensation
An attractive base salary commensurate with experience, along with a performance-based annual bonus program.
Equity/Stock Options
Opportunities for significant equity participation or stock options, aligning your success with the company’s growth.
Health & Wellness
Comprehensive medical, dental, and vision insurance plans for you and your family, with a significant portion of premiums covered by the company.
Retirement Savings
A robust 401(k) retirement plan with generous company matching contributions, helping you plan for your financial future.
Paid Time Off
Generous paid time off (PTO) policy, including vacation, sick leave, and company holidays, promoting work-life balance.
Professional Development
Significant investment in your professional growth, including tuition reimbursement, conference attendance, training programs, and opportunities for continuous learning.
Relocation Assistance
For qualified candidates, comprehensive relocation assistance is available to facilitate a smooth transition to the Boston area.
Innovative Environment
Work in a cutting-edge, state-of-the-art facility with access to advanced technologies and a collaborative, intellectually stimulating culture.
Impactful Work
The profound satisfaction of contributing to the development of therapies that genuinely improve and save lives.
Employee Assistance Program
Confidential support services for a variety of personal and work-related challenges.
Wellness Programs
Initiatives focused on promoting physical and mental well-being.
How to Apply
If you are a highly motivated and experienced bioprocess engineering leader ready to make a significant impact, we encourage you to apply. This is an unparalleled opportunity to join a leading biopharmaceutical company at a critical juncture of growth and innovation.
To express your interest and learn more about this exciting Director of Process Engineering (Bio) position, please submit your resume and a cover letter detailing your qualifications and career aspirations through JRG Partners’ dedicated Life Sciences practice area. Our expert recruiters specialize in connecting top talent with groundbreaking opportunities in the biopharmaceutical sector.
We look forward to reviewing your application and discussing how your expertise can contribute to our client’s mission of transforming patient lives.
