Project Manager, Technical Operations Life-cycle Management
Insmed Incorporated
6 hours ago
Remote friendly (Bridgewater, NJ)
United States
Operations
Project Manager, Life-cycle Management (Technical Operations)
Responsibilities:
- Support execution of lifecycle management projects within Technical Operations (Tech Ops), primarily for commercial products’ technical projects (e.g., device changes, combination product post-approval changes, artwork projects).
- Serve as central responsible coordinator across cross-functional Chemistry & Manufacturing Controls (CMC) teams to drive delivery with rigor, transparency, and urgency.
- Lead end-to-end post-approval project teams internally and with external partners.
- Guide projects from initial scope through lessons learned after completion; develop, maintain, and communicate comprehensive project timelines, milestones, deliverables, decisions, risks, and issues.
- Own cross-Insmed communication and follow-ups across relevant functions to ensure unified execution.
- Proactively identify risks and opportunities; develop mitigation strategies with technical experts and escalate critical issues.
- Liaison between Insmed project teams and external partners to align on scope, timelines, and deliverables.
- Represent PM function in governance forums (e.g., CMC Teams, Tech Ops Project Reviews) and report updates on milestones, risks, issues, and decisions.
- Establish and drive structured project frameworks with clear roles, deliverables, and decision-making processes.
- Deploy tools, visuals, and metrics to improve cohesion, visibility, and strategic alignment across Technical Operations.
- Support application of project management tools/approaches beyond the PM function.
- Support budget and resource planning with Technical Operations leadership.
- Contribute to a high-performing, people-centered project management culture emphasizing clear communication, shared success, and continuous improvement.
Qualifications:
- Bachelor’s degree + 5 years of project management experience OR Master’s degree + 3 years of project management experience.
- Project management experience in the pharmaceutical, biotech, medical device, or consumer health industry.
- Ability to lead multiple concurrent cross-functional project teams and drive accountability without direct authority.
Preferred (Nice to have):
- Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field.
- Understanding of CMC development lifecycle, regulatory submission processes, and post-approval change management.
- Experience with combination product/medical device post-approval projects.
- Proficiency with project management tools (MS Project, Excel, PowerPoint, SharePoint, Smartsheets).
- Ability to create clarity and thrive in fast-paced, regulated environments.
- PMP certification.
- Experience supporting commercial launch readiness (packaging validation, labeling approval workflows).
- Familiarity with inhaled drug delivery systems and nebulizer-based combination products.
- Experience with mock launch exercises and commercial launch scenario planning.
- Familiarity with global regulatory submissions (EU MAA, JNDA, US NDA/sNDA) and regional launch planning.
Benefits (explicitly listed):
- Comprehensive medical, dental, and vision coverage; mental health support; annual wellbeing reimbursement; Employee Assistance Program (EAP).
- Paid time off; fertility and family-forming benefits; caregiver support; flexible work schedules.
- 401(k) with company match; annual equity awards; Employee Stock Purchase Plan (ESPP); company-paid life and disability insurance.
- Company Learning Institute (LinkedIn Learning, workshops, leadership programs, mentorship, networking).
- Employee resource groups; service and recognition programs.
Application instructions:
- Current Insmed employees: apply via the Jobs Hub in Workday.
Responsibilities:
- Support execution of lifecycle management projects within Technical Operations (Tech Ops), primarily for commercial products’ technical projects (e.g., device changes, combination product post-approval changes, artwork projects).
- Serve as central responsible coordinator across cross-functional Chemistry & Manufacturing Controls (CMC) teams to drive delivery with rigor, transparency, and urgency.
- Lead end-to-end post-approval project teams internally and with external partners.
- Guide projects from initial scope through lessons learned after completion; develop, maintain, and communicate comprehensive project timelines, milestones, deliverables, decisions, risks, and issues.
- Own cross-Insmed communication and follow-ups across relevant functions to ensure unified execution.
- Proactively identify risks and opportunities; develop mitigation strategies with technical experts and escalate critical issues.
- Liaison between Insmed project teams and external partners to align on scope, timelines, and deliverables.
- Represent PM function in governance forums (e.g., CMC Teams, Tech Ops Project Reviews) and report updates on milestones, risks, issues, and decisions.
- Establish and drive structured project frameworks with clear roles, deliverables, and decision-making processes.
- Deploy tools, visuals, and metrics to improve cohesion, visibility, and strategic alignment across Technical Operations.
- Support application of project management tools/approaches beyond the PM function.
- Support budget and resource planning with Technical Operations leadership.
- Contribute to a high-performing, people-centered project management culture emphasizing clear communication, shared success, and continuous improvement.
Qualifications:
- Bachelor’s degree + 5 years of project management experience OR Master’s degree + 3 years of project management experience.
- Project management experience in the pharmaceutical, biotech, medical device, or consumer health industry.
- Ability to lead multiple concurrent cross-functional project teams and drive accountability without direct authority.
Preferred (Nice to have):
- Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field.
- Understanding of CMC development lifecycle, regulatory submission processes, and post-approval change management.
- Experience with combination product/medical device post-approval projects.
- Proficiency with project management tools (MS Project, Excel, PowerPoint, SharePoint, Smartsheets).
- Ability to create clarity and thrive in fast-paced, regulated environments.
- PMP certification.
- Experience supporting commercial launch readiness (packaging validation, labeling approval workflows).
- Familiarity with inhaled drug delivery systems and nebulizer-based combination products.
- Experience with mock launch exercises and commercial launch scenario planning.
- Familiarity with global regulatory submissions (EU MAA, JNDA, US NDA/sNDA) and regional launch planning.
Benefits (explicitly listed):
- Comprehensive medical, dental, and vision coverage; mental health support; annual wellbeing reimbursement; Employee Assistance Program (EAP).
- Paid time off; fertility and family-forming benefits; caregiver support; flexible work schedules.
- 401(k) with company match; annual equity awards; Employee Stock Purchase Plan (ESPP); company-paid life and disability insurance.
- Company Learning Institute (LinkedIn Learning, workshops, leadership programs, mentorship, networking).
- Employee resource groups; service and recognition programs.
Application instructions:
- Current Insmed employees: apply via the Jobs Hub in Workday.