Director, Project Management - Technical Operations

Role Summary

The Director, Project Management – Technical Operations will work closely with technical leads and cross-functional teams within and outside the company to facilitate meetings and interactions. This role requires attention to detail, strategic planning and organization skills, and effective collaboration to ensure clinical and commercial programs are supplied on time and on budget. Location: New Haven, CT.

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.

Qualifications

• 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).

Skills

• Project management
• Cross-functional collaboration
• Vendor and CDMO management
• Risk management and budgeting
• Strong written and verbal communication
• Analytical problem solving
• Proficiency with Microsoft Project, Smartsheet, and Microsoft Office