Our Vaccine client in Boston, MA is growing and looking to add a Sr/Executive Director, Head of Technical Operations! This leader will be responsible for providing scientific and technical oversight for research, process development, manufacturing and clinical supply. We are accountable for direct technical support of drug substance, drug product and analytical operations, with responsibility for all aspects of process design and development including tech transfer, process validation, GMP manufacturing support, process monitoring and data analytics. Our ideal candidate will have a background process development background and will provide strong organizational, strategic and scientific leadership of the Technical Development organization. In partnership with the CTO, the role will set process development strategy and priorities for viral vaccine programs. The successful candidate will lead the early and late-stage development, scale up and technical transfer of diverse VLP based drug discovery targets and will use their deep expertise in protein biochemistry, process sciences and bioanalytical methods to support all stage of process design and development from harvest through formulation and storage.
The successful candidate will be a primary member of the product development team and is accountable for scientific and technical leadership of a team of scientists and engineers responsible for process development including cell culture, purification, drug substance and drug product. The scope includes improving existing processes and developing next-generation processes. The Head, Technical Development will also be an important contributor to define and lead process development strategy, oversee functional laboratory activities, and develop a technical team.
- Manage multiple, complex near and long- term portfolio deliverables for early phase and life cycle management developmental programs for recombinant viral vaccines.
- Lead multifunction team and collaborate with partner functions (i.e. Research, Analytical Development, Manufacturing Science & Technology, , Manufacturing, Quality, Validation, Regulatory) to support viral vaccine process, product development strategy and implementation in manufacturing
- Develop and implement the process development strategy as the leader and technical expert for recombinant viral vaccine processes with a focus on productivity (i.e. yield), process capability (i.e. robust impurity control), scalability and economic viability
- Provide technical leadership to a team of process engineers, and scientists for new product introductions, and lifecycle management, including overseeing the design of studies, completion of investigations and writing/review of technical reports.
- Define and implement phase-appropriate strategies, business processes, systems, and practices for efficient achievement of process and product development deliverables in accordance with cGMP and ICH guidelines and industry best practices.
- Direct and integrate development projects across departments (cell culture, purification, formulation) to deliver program goals
- Identify innovation opportunities in cell culture, purification, virology, and drug product formulation to enhance bioprocess development projects
- Partner with Operations to transfer processes into manufacturing, and provides technical support during tech transfer and validation (i.e. process performance qualification) activities
- Use experience in bioprocess development to provide technical support for production of drug substance and drug product in GMP manufacturing
- Use scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require TD support
- Develop multifunction laboratory infrastructure strategy including facilities and equipment, and implements new technology to meet process and product development program goals
- Produce high quality technical presentations for internal audiences including senior leadership to update on program technical progress
- Identify collaboration opportunities and provide technical oversight of product and process development activities sub-contracted to 3rd party development and manufacturing organizations
- Represent TD on R&D and Technical Operations leadership teams to provide program oversight, define strategy, and adherence to project plans
- Contribute to CMC sections of regulatory license documents (e.g. IND, BLA)
- Develop multifunction team strategy and structure, recruit personnel, and build capability to meet process and product development program goals
- Champion innovation and continuous improvement
- Proactively develop and sustain strong relationships with internal/external stakeholders.
- A Ph.D. degree in Bio/Chemical engineering, Biochemistry, Virology, Pharmaceutical Sciences, or Protein Chemistry with more than 10 years of CMC process development and manufacturing experience
- Demonstrated competency, experience, and knowledge in CMC development and manufacturing requirements from early to late phases within the bio/pharmaceutical industry
- Specific hands-on experience in one or multiple of the following focus areas: upstream or downstream process design, development, process characterization and process and developing process and analytical control strategy
- Strong understanding and extensive hands?on experience in process development and/or MSAT. Deep understanding of product quality attributes control strategies as applied to biopharmaceutical processes. Sound background in process development, using QbD and PAT tools, large-scale processing and engineering fundamentals as applied to biopharmaceutical processes.
- Broad technical expertise in bioprocess design and development including cell culture and protein purification unit operations, ideally for production of viral vaccines
- Knowledge of bio analytical methods, characterization and bio product formulation, and fill/finish technology is desirable
- Strong knowledge of cGMP requirements for clinical and commercial testing & manufacturing. In-depth knowledge of industry best practices & trends.
- Demonstrated ability to prioritize and manage multiple tasks simultaneously, identify and resolve issues, and effectively manage timelines
- Ability to work effectively independently and collaboratively in a team environment in a rapid-paced, cross-functional environment
- Experience preparing operational budgets is a plus
Travel, Physical Demands & Work Environment:
- Strong preference for Boston local candidates to be on-site 2-3 days per week.
- Willingness to travel (10-25%) to other locations for various meetings and conferences, including overnight trips.