Demo

Program Manager - Assay

CoFactor Recruitment
Fremont, CA Full Time
POSTED ON 3/24/2025
AVAILABLE BEFORE 4/20/2025

Program Manager - Assay Development

Here’s a reworded version of the job description that maintains the essence while making it less identifiable :

Role Overview :

We are seeking a proactive, detail-oriented Program Manager with exceptional organizational, communication, and leadership abilities to spearhead the development, integration, and launch of innovative cellular analysis products. The ideal candidate will thrive in a fast-paced, collaborative environment, effectively coordinating diverse teams and driving projects to completion under tight timelines. A strong foundation in science or engineering is essential, as is a proven track record of managing high-impact, multifaceted projects.

Key Responsibilities :

  • Lead and coordinate cross-functional project teams, working closely with departments such as R&D, product management, quality assurance, manufacturing, and tech transfer.
  • Develop comprehensive project plans in collaboration with stakeholders and manage project timelines to ensure milestones are achieved.
  • Facilitate productive team meetings, documenting decisions, open issues, and action items, and following up to ensure timely resolution.
  • Navigate ISO 13485 design control processes, maintaining high-quality documentation and ensuring compliance with standards.
  • Foster a collaborative team culture, driving alignment on goals and creating a shared sense of purpose.
  • Communicate project updates to leadership, highlighting progress, risks, and mitigation strategies.
  • Identify and address technical and resource challenges, collaborating with key stakeholders to remove roadblocks and make informed trade-offs.

Qualifications :

  • Bachelor’s degree (or higher) in Life Sciences, Engineering, or a related field.
  • Minimum of 5 years of project management experience in the biotech, medical device, or pharmaceutical industry, with a strong technical background.
  • Familiarity with ISO 13485 design control standards and quality management systems.
  • Proven ability to manage ambiguity and drive solutions in a dynamic environment.
  • Strong influencing skills, with the ability to build consensus and resolve conflicts tactfully.
  • Excellent written and verbal communication skills, with experience presenting to senior leadership and fostering collaboration across teams.
  • Proficiency with project management tools (e.g., Smartsheets, Asana, JIRA, Confluence).
  • Experience with flow cytometry, or both physical (hardware, reagents) and software product development, is highly desirable.
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