We are currently seeking a Senior Director of Process Development for a growing biologics company based in Boston, MA. The company is focused on novel protein delivery methods using their proprietary technology. As a Senior Director of Process Development, you will be responsible for leading and overseeing development projects across multiple workstreams, with an emphasis on scale-up and commercialization. This is a leadership/managerial role that requires a highly experienced and technically skilled individual who can provide strategic, technical, and scientific leadership to the development team.
As the Senior Director of Process Development, you will be responsible for the following:
- Lead and oversee development projects across multiple workstreams, with an emphasis on scale-up and commercialization.
- Provide technical leadership and management of current and future clinical-phase programs, including thorough process characterization/optimization, technology transfers (internal and external), and development of source documents for regulatory filings.
- Provide strategic, technical, and scientific leadership to the development team assessing and implementing new technology to achieve robust processes in alignment with company's objectives.
- Collaborate closely with peer function teams and communicate complex technical topics and decisions within the department and to program teams and provide effective technical and business leadership.
- Ensure seamless transition of unit operations from bench-scale to clinical scale, implementing a robust process control strategy.
- Conduct risk assessments and troubleshoot any technical issues that arise during process development, providing timely solutions and recommendations.
- Work collaboratively with process development leadership to develop and/or optimize the company's platform technology to support a multi-product portfolio of clinical development programs.
- Identify and follow through on opportunities for innovation, intensification, or improvement in the manufacturing process, lead feasibility assessments and basic performance evaluation for unit operations.
- Maintain accurate and comprehensive documentation of process development activities, including protocols, reports, and standard operating procedures (SOPs). Prepare and present regular progress reports to senior management, highlighting achievements, challenges, and future plans.
- Lead program-specific process development activities for internal and external clients
- Lead a team of process engineers and scientists, providing guidance, mentorship, and support to ensure their professional growth and development.
- Foster a collaborative and innovative environment, promoting cross-functional teamwork and effective communication among team members and cross-functional stakeholders at various levels of the organization.
- Degree in chemical or mechanical engineering, or other relevant scientific discipline is required.
- B.S. and 18+ years, M.S. and 15+ years, or Ph.D. and 12+ years process development experience, preferably developing large molecule drugs.
- Prior experience managing technical team members; Passion for people management and development.
- Subject Matter Expertise in characterizing, optimizing, integrating, and up/down scale of process operations such as pumping, mixing, blending, liquid handling, drying, separation/filtration, and fill-finish.
- Proven technical judgement and leadership abilities and a demonstrated capacity to work independently on multiple parallel projects.
- Solid understanding of cGMPs and ICH guidelines as they relate to clinical process development.
- Demonstrated ability to positively influence outcomes, key project decisions, and strategic problem-solving.
- Proven ability to communicate clearly and present key information objectively (verbally and in writing) to all levels of the organization, including executive management.