Sr. Project Manager - CMC

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens. HIL-214 has been studied in eight Phase I/II studies in more than 4,500 subjects. HilleVax is currently planning initiation of a Ph 2b study in infants.

We are a rapidly growing and dynamic organization that is founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health. Our goal is to build a company that equalizes opportunity for people around the world by removing barriers of health inequity, and we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases.

Objectives / Overview:

The CMC Project Manager will work with a cross functional team across Tech Ops, including Manufacturing, Supply Chain, and Assay Development. They will be a member of the core program team representing CMC and will partner with Tech Ops and other leaders in the development and implementation of CMC project strategies and comprehensive project plans.

The Project Manager will plan for Tech Ops related activities; manage and track key CMC activities; anticipate, resolve, and escalate issues; coordinate CMC plans with global development and forecasted plans. The CMC Project Manager will also contribute to developing and sustaining effective Project Management business processes within Technical Operations.

Responsibilities:

• Effectively coordinate cross-functional CMC Team.

• Consistent meeting management (agendas, desired outcomes, read-ahead documents, minutes, etc.).

• Consistent use of project tracking tools (Primavera, MS Project, dashboards, etc.).

• Plan/manage/track key CMC activities, including identifying responsible individuals.

• DS, DP, API labeling and packaging.

• Regulatory submissions, including the tracking of INDs (and the comparable filings on a country-by-country basis) approved in particular countries and the timing for introduction of clinical products.

• Support CMC planning for regulatory filings worldwide.

• Coordinate CMC program plans with global distribution plans.

• Monitor contractor status, including the tracking-to-closure of CMO deviations.

• Anticipate, escalate and resolve issues as appropriate (technical, processing, compliance, resource and facility/equipment issues).

• Utilize program data in tools that feed into a portfolio view of TOPS activities across CMC product programs.

• Assist in developing contract manufacturing production and clinical development plans.

• Lead CMC teams in establishing clear scope of work and drive team towards the delivery of project milestones on time, on budget, and within scope through utilization of project management tools.

• Identify CMC project objectives.

• Build fully integrated project schedules capturing all activities and resources needed to deliver against corporate goals.

• Identify measurable success criteria.

• Monitor project progress and identify risks and opportunities to timeline, budget or scope.

• Ensure adequate plans are in place to mitigate risks and enable opportunities.

• Effectively communicate progress at all levels and escalate critical issues appropriately.

• Ensure project sub-teams apply the techniques stated above to their planning.

• Assist CMC leadership with management of the CMC budget by monitoring actuals to plan and forecasting; assist with tracking program costs to be consistent with budgets.

• Facilitate and incorporate lessons learned, best practices, etc.

• Coordinate and lead internal and CMC-Vendor meetings, and document and communicate key takeaways to relevant constituents.

Education, Experience & Skills:

• Bachelor's Degree in a scientific/engineering discipline required; advanced degree in science/engineering or MBA preferred.

• Project Management certification or equivalent (PMP or equivalent experience with risk management practices is a plus).

• 5+ years' of relevant industry experience, particularly in the development of vaccines. Must have experience with managing clinical pharmaceutical products from a project management and supply chain perspective. Experience with recent regulatory trends is preferred.

• 2+ years' of experience within a CMC function or group with hands-on experience in late phase drug product development or 2 years' of specific CMC project management experience with complex manufacturing development processes.

• Superior organizational, written and verbal communication skills, and attention to detail.

• Strong knowledge of team dynamics, structure, roles and responsibilities.

• Excellent ability to embrace ambiguity and complexity and demonstrate problem solving with limited oversight; ability to translate complex concepts into actionable, measurable tasks.

• Ability to respond quickly and effectively to changing environments.

• Excellent interpersonal skills, including clear, succinct and timely communication.

• Ability to ensure the integrity and accuracy of CMC program information to meet management requirements.

• Working knowledge of project management practices either from a formal PM background or from extensive experience in managing projects or programs.

• Skilled facilitator and negotiator with a keen eye for detail.

• Ability to work both independently and in a team focused environment.

• Strong influence, negotiation, analytical and presentation skills.

• Ability to work effectively with cross-functional teams.

• Extensive experience with Microsoft Office (especially Excel, PowerPoint and Project).

Travel, Physical Demands & Work Environment:

• Travel domestic and international - less than 25%
• Boston-local candidates preferred.

HilleVax is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We welcome all to apply.