Director Biologics Process Development – Boston, MA
Are you a strategic leader passionate about advancing biologics manufacturing and process innovation? We are seeking a Director of Biologics Process Development to lead cutting-edge initiatives in biologics drug development at a pioneering company based in Boston, MA. This is a unique opportunity to drive scalable process solutions, optimize production workflows, and accelerate timelines in a fast-evolving biotech landscape. If you thrive at the intersection of science and leadership and have a proven track record in biologics process development, this role will empower you to shape the future of biologics manufacturing.
Drive Innovation in Biologics Process Development
Join a leading biotech organization in Boston focused on developing breakthrough biologics therapies. The ideal candidate will possess deep expertise in upstream and downstream process development, strong project leadership skills, and the ability to collaborate cross-functionally to deliver high-quality, efficient manufacturing processes. If you are motivated by scientific excellence, operational rigor, and team leadership, this role offers an impactful platform to advance biologics process technologies and deliver life-changing therapies.
Key Responsibilities of the Director Biologics Process Development
Process Development Strategy: Lead the design and execution of scalable upstream and downstream biologics process development strategies that align with pipeline goals and regulatory requirements. Drive innovation to improve process efficiency, yield, and product quality.
Cross-Functional Collaboration: Partner closely with Research, Analytical Development, Manufacturing, and Quality teams to ensure seamless technology transfer and robust process characterization supporting clinical and commercial supply.
Team Leadership & Development: Build, mentor, and lead a high-performing process development team. Foster a collaborative culture focused on scientific rigor, continuous improvement, and operational excellence.
Project Management & Execution: Oversee multiple biologics process development projects from early-stage research through clinical manufacturing. Ensure milestones are met on time, within budget, and in compliance with regulatory standards.
Technology Implementation & Optimization: Evaluate and integrate novel technologies and platforms to enhance biologics production workflows. Champion continuous process improvements and implement best practices in bioprocessing.
Regulatory Compliance & Documentation: Ensure that all process development activities adhere to cGMP standards and support regulatory submissions with comprehensive documentation and validation protocols.
Resource Planning & Budget Management: Manage departmental budgets, allocate resources effectively, and identify cost-saving opportunities without compromising quality or timelines.
Stakeholder Communication: Serve as a key liaison between process development, senior leadership, and external partners. Provide clear, data-driven updates on project progress, challenges, and strategic direction.
What the Client is Looking for in You
As the Director of Biologics Process Development, the client seeks an innovative and strategic leader with a strong scientific foundation and demonstrated success in advancing biologics manufacturing processes. You should be a results-oriented professional who excels at leading complex process development initiatives in a fast-paced biotech environment, while driving operational excellence and collaboration across teams.
Proven Expertise in Biologics Process Development
The client is looking for a candidate with extensive experience in upstream and downstream biologics process development. You should have a proven track record of developing scalable, robust processes that support clinical and commercial manufacturing. Experience in process optimization, tech transfer, and compliance with cGMP and regulatory guidelines is highly valued.
Strategic Innovator with a Growth Mindset
You must demonstrate the ability to design and implement innovative process development strategies that align with organizational goals and accelerate pipeline advancement. The ideal candidate anticipates emerging technologies and industry trends to continually improve process efficiency, product quality, and timelines.
Strong Leadership and Team Development Skills
Leadership is critical in this role. The client seeks a director who can inspire, mentor, and grow a high-performing process development team. You should foster a culture of scientific excellence, accountability, and cross-functional collaboration to deliver impactful results.
Operational and Financial Acumen
The ability to manage departmental resources, timelines, and budgets effectively is essential. You should be capable of prioritizing projects, allocating resources wisely, and driving cost-effective process solutions without compromising quality or compliance.
Collaborative Communicator and Stakeholder Partner
You will be expected to build strong relationships with internal teams, external partners, and senior leadership. The client values clear, transparent communication and someone who can present complex technical data in a way that supports informed decision-making and strategic planning.
Commitment to Regulatory Compliance and Quality
The client values a leader who prioritizes compliance with industry regulations, cGMP standards, and quality assurance practices. You should have a thorough understanding of risk management and documentation practices to ensure robust and compliant process development activities.
FAQs About the Role – Director Biologics Process Development
What are the key responsibilities of the Director of Biologics Process Development?
As the Director of Biologics Process Development, you will lead the design and execution of scalable upstream and downstream processes to support clinical and commercial biologics manufacturing. You will manage cross-functional collaborations, oversee project timelines and budgets, mentor your team, and ensure compliance with regulatory standards. Driving process innovation and continuous improvement will be central to your role.
What qualifications and experience are required for this position?
The ideal candidate will have extensive experience in biologics process development, including upstream and downstream bioprocessing, technology transfer, and cGMP manufacturing. A strong scientific background in biotechnology, biochemical engineering, or related fields is essential, along with leadership experience managing technical teams. Advanced degrees (MS or PhD) in relevant disciplines are highly preferred.
What leadership qualities are essential for this role?
The client is looking for a strategic and collaborative leader who can inspire scientific excellence and operational rigor. Strong communication skills, the ability to manage complex projects, mentor team members, and foster cross-functional partnerships are key. You should be adaptable and driven to innovate within a fast-paced biotech environment.
What challenges can I expect in this role?
Challenges include navigating the complexities of scaling biologics processes from early development to commercial production, ensuring regulatory compliance, managing timelines and budgets, and integrating new technologies. Balancing scientific innovation with operational feasibility and cross-team alignment will also be important.
What is the expected impact of the Director on the company’s biologics pipeline?
You will play a critical role in accelerating the development and manufacturing readiness of biologics candidates, improving process robustness, and reducing time-to-market. Your leadership will directly influence the company’s ability to deliver high-quality biologic therapies efficiently and compliantly.
What is the company’s culture and work environment like?
The company values a collaborative, innovative, and science-driven culture where teamwork and continuous learning are encouraged. You will join a dynamic environment focused on breakthrough biologics development and operational excellence, with opportunities to contribute to meaningful therapeutic advancements.
What Remuneration Can You Expect from This Job?
As the Director of Biologics Process Development based in Boston, MA, you can anticipate a competitive and comprehensive compensation package designed to attract and retain experienced scientific leaders in the biopharmaceutical industry. The remuneration typically includes:
Base Salary
The base salary for a Director-level position in biologics process development generally ranges between $150,000 and $220,000 annually, depending on the company’s size, stage, and your experience level. Larger biotech or pharmaceutical companies often offer salaries at the higher end of this range.
Performance-Based Bonuses
In addition to your base salary, many employers offer annual performance bonuses tied to individual and company goals such as project milestones, process improvements, and pipeline advancement. These bonuses can range from 10% to 30% of the base salary.
Equity & Stock Options
Equity compensation is common in biotech firms to align employee incentives with company growth. You may receive stock options, restricted stock units (RSUs), or other equity awards, which can form a significant portion of your total compensation, especially in startups or high-growth companies.
Long-Term Incentive Plans (LTIPs)
Some companies offer LTIPs or profit-sharing schemes that reward sustained contributions to company success. These incentives encourage a long-term commitment and provide additional financial upside based on company performance.
Executive Benefits & Perks
Benefit packages typically include:
Comprehensive health, dental, and vision insurance
Retirement savings plans with company matching (401(k) or equivalent)
Paid time off and flexible work arrangements
Professional development opportunities and conference allowances
Wellness programs and employee assistance resources
Signing Bonuses & Relocation Assistance
For top candidates, signing bonuses and relocation packages may be provided to ease the transition to the Boston area. These one-time incentives can vary widely depending on company policy and candidate experience.
Total Compensation Potential
Combining base salary, bonuses, equity, and benefits, total compensation for a Director of Biologics Process Development in Boston can range from approximately $180,000 to $300,000+ annually. In high-growth companies or with exceptional candidates, this figure may be even higher.
How to Apply
If you are an experienced and innovative leader in biologics process development, we invite you to apply for the Director Biologics Process Development position in Boston, MA. This is an exciting opportunity to drive process innovation, optimize biologics manufacturing, and lead cross-functional teams in a cutting-edge biopharmaceutical environment.
To apply, please submit your resume and a cover letter outlining your experience in biologics process development, scale-up, process optimization, and team leadership. Be sure to highlight your achievements in developing robust manufacturing processes, advancing biologics pipelines, and collaborating effectively with R&D and manufacturing teams.
This role offers a high-impact career opportunity where you will play a crucial role in advancing therapeutic development and shaping manufacturing strategies for next-generation biologics. Apply today to take the next step in your scientific leadership career as Director Biologics Process Development in Boston, MA!
For more information or to explore similar roles in biopharma process development, please visit our Biologics Recruiting Experts page.
Tags:
Biologics Process Development | Director Level Jobs | Biopharmaceutical Manufacturing | Process Optimization | Biologics Scale-up | Team Leadership | Boston Biotech Jobs | Therapeutic Development | Bioprocess Engineering
