Broad Institute

Job Description

The Vallabh/Minikel lab and the Vector Engineering lab at the Broad Institute of MIT jointly seek a PhD-level Senior Project Manager motivated to impact human health by driving multiple projects of therapeutic and translational importance. This initiative is led by Dr. Sonia Vallabh, who became a scientist in response to her own genetic test report, and Dr. Ben Deverman, who leads the Vector Engineering laboratory at the Broad Institute specializes in engineering Central Nervous System (CNS)-targeting adeno-associated viruses (AAV) to deliver therapeutic genes to the brain.

The goal of our work is to discover, develop, characterize and advance effective treatments for prion disease, a rapidly fatal and currently incurable neurodegenerative disease. You can read more about our labs and missions here.

Vector Engineering laboratory

The Senior Project Manager will play a key role in an exciting new multi-lab collaboration to develop a gene therapy designed to reduce prion protein (PrP) levels in the human brain. Together we form a mission-driven team aiming to submit an Investigational New Drug (IND) application in less than five years. 

Beyond gene therapy, the Senior Project Manager will serve as champion for a number of different projects, all united by translational urgency. All are highly collaborative and require exceptional people skills and team spirit. They will also require facility with the science and the ability to organize and manage highly complex and dynamic multi-year, multi-lab undertakings while maintaining razor focus on the larger goal.

Responsibilities

·      The Senior Project Manager will work closely with PIs Sonia Vallabh, Eric Minikel and Ben Deverman as well as with a number of collaborating labs, external Contract Research Organization’s (CROs), and funding partners in the context of multi-lab, multi-year therapeutic development initiatives.

·      This individual will serve as a thought partner regarding overall lab operations including the labs’ scientific portfolio, finances and fundraising.

·      They will have both a proven track record of scientific accomplishments and project management experience. They will be responsible for communicating and coordinating all aspects of scientific execution, compliance, and alliance management, and for monitoring timelines and milestones.

·      They will also be responsible for managing key relationships with consortium members, external partners, vendors, and SAB members.

·      The Senior Project Manager will be expected to contribute positively to a high-functioning team capable of anticipating and solving problems, removing obstacles, and maximizing the scientific impact of the team.

·      Above all they will embrace the dynamism of the mission and this role, proactively stepping up to identify and solve problems as they arise.

Other duties:

·      Work closely with the Principal Investigators (PIs) to keep projects on operational and financial track.

·      Coordinate internal and external manufacturing and Chemistry, manufacturing, and Controls (CMC) studies for the AAV gene therapy candidate, adhering to project timelines, milestones, and budget.

·      Oversee the development and implementation of manufacturing processes, including vector production, purification, and analytical testing, to ensure the production of high-quality AAV products.

·      Work proactively to identify resourcing problems to ensure project timelines are met; work proactively to identify potential obstacles and blocking issues between collaborators

·      Develop and maintain project plans, including detailed timelines, deliverables, and resource requirements. Assist in the development of reports and updates to collaborators and funding agencies. Ensure that all scientific, financial and administrative correspondence, reports, and other related documents are submitted to meet our obligations

·      Coordinate and oversee technology transfer activities between research and manufacturing groups.

·      Closely monitor scientific progress across projects and anticipate unexpected changes in resourcing or project utilization

·      Organize and provide input on agendas for consortium meetings

·      Attend meetings, generate meeting notes and action items, and assist in setting agendas.

·      Work proactively to identify and resolve operational or resourcing problems to ensure project timelines are met.

·      Prepare and review relevant documentation, including batch records, standard operating procedures (SOPs), and regulatory submissions, to support IND-enabling activities.

·      Collaborate with regulatory affairs personnel to ensure that all manufacturing and CMC activities meet the necessary regulatory requirements for IND submission.

·      Stay abreast of the latest advancements in gene therapy manufacturing and CMC processes and apply relevant knowledge to optimize the development and production of the gene therapy product.

Qualifications:

·      Advanced degree in life sciences (Ph.D.) required. Background in neurodegenerative disease research preferable.

·      At least 5 years of experience working with cross-functional teams in the biotechnology or pharmaceutical industry, with a focus on gene or cell therapy manufacturing and CMC activities.

·      In-depth knowledge and experience working on gene or cell therapy production, purification, and analytical characterization, managing supply chains, and knowledge of current regulatory guidelines for gene therapy products.

·      Experience working with CMOs for the manufacturing of gene or cell therapy products.

·      Excellent organizational and time management skills, with the ability to prioritize and multitask effectively to meet project deadlines.

·      Attention to detail and a commitment to maintaining high standards.

·      Strong project management skills with demonstrated ability to effectively keep teams, projects and deliverables on track

·      Demonstrated ability to work independently and collaboratively, multi-task, adapt to changing priorities, and to work in a fast-paced environment

·      Exceptional writing skills for both scientific and non-scientific audiences. Exceptional communication and people skills, a strong team spirit, and a demonstrated ability to effectively collaborate with internal and external stakeholders, including scientists, engineers, regulatory professionals, and manufacturing personnel.