Lead the development and commercialization of RUO and regulated Next Generation Sequencing (NGS) instrument and assay solutions
Serve as Core Team Lead for multiple New Product Introductions and Sustaining programs
Proactively identify risks and mitigations
Develop and control program timelines with internal functions and external partners
Build, monitor, and control budgets with Finance and vendors
Conduct internal and external team meetings
Present and communicate to senior leadership at Product Approval Committee (PAC) checkpoint meetings
Ensure compliance to company Product Commercialization Process (PCP) and Quality Management Systems (QMS) for developing RUO and regulated products
Requirements
BS in Molecular Biology, Genetics, or Engineering
Masters, MBA, and/or Certified Project Management Professional (PMP) preferred
7 plus years program management experience including principles, tools and applications (i.e., timeline management, prioritization, cost estimation, risks analysis, and core team leadership)
Led multiple product development programs to completion
Experience with regulated medical devices developed under 21 CFR Part 820 Subpart C - Design Controls (or other regulated product development such as drugs or biologics)
Proficiency with Project Management software to lead intricate program timelines and resources
Outstanding written and verbal presentation skills: Assertively and effectively articulates sophisticated concepts and ideas to broad audiences
Confident communication: Interacts with all levels of management, stays focused and on-point, and able to raise problems or challenges in productive manner
Financial competence: Leads all aspects of program budgets and reports into Profit & Loss (P&L) statements
Outstanding influencing skills: Gets things done and drives decisions without formal authority
Strong interpersonal skills: Champions relationships across the matrixed organization to resolve discord thoughtfully
Benefits
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Next Generation Sequencing (NGS)program managementtimeline managementcost estimationrisk analysiscore team leadershipproduct developmentregulatory compliancedesign controlsProject Management software
Soft skills
written communicationverbal communicationconfident communicationinfluencing skillsinterpersonal skillsproblem-solvingpresentation skillsrelationship managementassertivenessfocus
Certifications
Certified Project Management Professional (PMP)MBA