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Invivyd · 1 month ago

Director, Project Management - Technical Operations

New Haven, CT (Northeast Preferred)

Full-time

Onsite

Director/Executive

7+ years exp

Invivyd is a company dedicated to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. The Director, Project Management – Technical Operations will oversee interactions within Technical Operations and cross-functional teams to ensure clinical and commercial programs are delivered on time and on budget.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Facilitate and manage interactions and meetings within Tech Ops and with outside vendors including agendas and minutes, action items. As required, interact with outside collaborators and partners to ensure alignment, reach consensus, and drive timely decision making

Facilitate cross-functional integration and alignment between all Tech Ops functions including process development, analytical, formulation, manufacturing, quality, and supply chain. Maintain and administer timelines to ensure on-time deliverables for the group

In collaboration with Tech Ops leadership, create the Tech Ops project plan (both short and long term) and ensure alignment and integration into overall program plan(s). Actively manage the plan, timelines and deliverables including tracking of project milestones, and driving near-term team decision-making with input from program team(s)

Develop and execute Tech Ops project specific risk management exercises such that project risks are systematically defined, quantified, assessed, and appropriately mitigated

Plan/manage Tech Ops specific budgets, track expenditures and resource usage

Assist with management of documents to support internal information management

Qualification

Cross-functional ManagementBiopharmaceutical DevelopmentProject ManagementCDMO ManagementGMP RegulationsMicrosoft ProjectAnalytical SkillsInterpersonal SkillsOrganizational SkillsCommunication Skills

Required

Bachelor's degree in a Life Science or related field with a minimum of 10 years industry experience specifically in cross-functional management within Tech Ops, preferably manufacturing or development, or advanced degree and a minimum of 7 years of experience

Experience in achieving project objectives through an outsourced CDMO model

Outstanding interpersonal skills

Excellent verbal and written communication skills

Excellent organizational skills

Strong analytical and problem-solving skills

Ability to prioritize work and take initiative when necessary

Ability to work well with external collaborators with professionalism and discretion

A thorough understanding of the science and technology associated with biopharmaceutical product development, including functional interdependencies between development, manufacturing, quality, and supply chain at all program stages

Experience in establishing and managing external CDMOs / CROs in coordination with Tech Ops technical leads to ensure timely delivery of clear, accurate and well written reports

Strong knowledge of drug development and FDA/ICH guidance documents regarding GMP regulations

Outstanding software skills, particularly Microsoft Project / Smartsheet and the Microsoft Office suite; expertise with project management tools (e.g. timelines, dashboards)