Interim Executive Director, Center for Advanced Biological Innovation & Manufacturing
361062 Administrative Manager
Harvard University is seeking an experienced Executive Director to work collaboratively with an advanced biological innovation and manufacturing facility Board of Directors, as well as faculty and senior researchers to build upon and complement existing regional resources to deliver cutting-edge, safe, reliable and consistent service in the research, development and manufacture of clinical material.
The advanced biological innovation and manufacturing facilitys mission is to provide unique and cutting-edge capabilities and resources to assist with the design and manufacture of advanced cell-based therapies and to provide regulatory expertise appropriate at each stage of the translational process. The facilitys focus is to address key challenges, needs and priorities in the wider Boston area, including:
- Workforce development - critical in academic labs that mostly lack the manufacturing skills to bring their technologies closer to the patient, as well as in manufacturing and quality control where training and retention can be a challenge.
- Efficient integration of various phases of translation - balancing improved access and understanding of appropriate models with timely initiation of Phase I/Phase II clinical studies.
- Employing emerging disciplines exploring the potential for artificial intelligence/machine learning-driven advances and innovations and their clinical applications.
- Flexibility, adaptability and modularity exploiting a wide range of innovations that exist or may emerge in the coming years.
- Economies of scale - sharing cost and spreading risk that for, cell-based therapies, are considerable.
Organization and Role Evolution
The facility will be incorporated and operated as a non-profit organization, separate from all its stakeholder institutions. Beyond researchers within these institutions, access to the facility is provided to local investigators in MA and external investigators, depending on space availability.
Towards fulfilling its mission, the facilitys organizational structure encompasses and delivers on unique differentiators within academia and beyond. These include:
Flexibility and agility to adjust or re-orient resources according to the requirements of new innovations and ideas in the cell-based therapies and cell manufacturing space.
A unique environment and culture that integrates faculty, fellows, students and clinicians with experts in regulatory matters, staff scientists, engineers and administrators in a wide range of relevant disciplines for focused and accelerated technology development and translation.
The pre-clinical space as a sustained source of new cGMP projects, offering the advantage of continuity in development to facility users and consistency in facility utilization.
Access to well-integrated, cutting edge resources and infrastructure for use by multiple stakeholders in a variety of disciplines and technological areas, hence maximizing resources and distributing risk.
Highly skilled, cutting-edge workforce development and training by optimizing information and knowledge flow; crosscutting technical areas of expertise such as biology, manufacturing techniques and approaches, statistics, chemistry, computation and engineering; and spanning multiple stages in the translational process.
- Oversee the facilitys space design and construction [or fit out], and associated financial planning, real estate deals and capital equipment manufacturers;
- Lead the facilitys initial business development efforts, including establishing collaborations with academia, industry, government and hospitals to promote the facilitys mission and achieve its operational goals;
- Serve as the main liaison between the Board of Directors and all stakeholders and manage communications and outreach to promote a broad understanding of the facility mission;
- Develop financial models and projections;
- Initiate a culture of innovation, collaboration and translation
Candidates MUST meet the following basic qualifications in order to be considered for this role:
- Minimum of 15 years of experience working in academic or research environments, preferably in setting up new initiatives or ventures;
- At least five years of COO experience or equivalent;
- Advanced degreein medicine/life sciences and/or MBA required.
- Deep understanding of the pharma/biotech industry, venture capital, and technology translation;
- Knowledge of cGMP operations and manufacturing and the US regulatory environment;
- Strong written and verbal skills are essential
- Working effectively as part of a leadership team characterized by trust, open communication, and shared goals
- Ability to build collaborative relationships successfully with multiple constituencies and within complex structures
- Driving strategic resource planning and budgeting, operations and risk management
- Recruiting, developing, and retaining a high-performing workforce
- Building diversity and instilling values related to equity and inclusion
- Experience working in the non-profit sector is a plus
- Passionate leader who embraces a culture of innovation and collaboration
- Strong communicator and networker
- Fact driven, proactive and effective decision maker with the willingness and resolve to make difficult decisions
- Unquestioned integrity, work ethic and trustworthiness
Full time. Monday through Friday. 35 hours Per week.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.
Associated topics: bio, bioinformatic, biology, biomedical, biomedical engineer, bioprocessing, fermentation, genetic, neurodegenerative, pathogenesis