Senior Project Manager
PharmaBiotechMedTechRegulatory AffairsQuality Assuranceheorgmpiso 13485croinform
Job description
By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. Pay Range: $100,100.00 - $164,450.00 Position Summary The Senior Project Manager will lead complex New Product Introduction (NPI), sustaining engineering, and strategic initiatives across Bio-Techne with a primary focus on Simple Western and Biologics products. This role partners with R&D, Systems Engineering, Mechanical Engineering, Software, Manufacturing, Quality, Regulatory, Supply Chain, Product Management, and Commercial teams to deliver instrument, consumable, reagent, and software products from concept through launch and lifecycle management. Key Responsibilities Lead multiple complex NPI, sustaining engineering, and strategic initiatives across the ASD portfolio, with primary focus on Simple Western and Biologics. Drive cross-functional teams through product development, verification, validation, manufacturing transfer, launch, and post-launch activities. Develop integrated project plans, critical paths, resource forecasts, and dependency management across hardware, software, consumable, reagent, and manufacturing workstreams. Identify, communicate, and mitigate technical, schedule, supply chain, quality, and commercialization risks. Facilitate phase-gate reviews, design reviews, executive reviews, and portfolio governance activities. Partner with Engineering, Product Management, Supply Chain, Manufacturing, Quality, Regulatory, and Commercial teams to achieve project objectives. Provide concise executive-level communication on project status, risks, mitigation plans, and decisions required. Use data analytics and AI-enabled tools to improve execution, forecasting, reporting, and portfolio visibility. Develop portfolio dashboards and metrics using Power BI, Jira, Smartsheet, or other platforms. Drive resolution of complex technical and organizational challenges through influence and cross-functional collaboration. Coach project managers and contribute to continuous improvement of PMO processes, tools, and best practices. Required Qualifications Education and Experience Bachelor's degree in mechanical engineering, Biomedical Engineering, Chemical Engineering, Systems Engineering, Life Sciences, or related discipline. 8+ years of technical project or program management experience in life sciences, biotechnology, medical devices, analytical instrumentation, or a related industry. Demonstrated experience managing multiple concurrent NPI programs and leading cross-functional teams through the full product lifecycle. Experience collaborating with mechanical, electrical, software, systems, manufacturing, quality, regulatory, and supply chain functions. Experience presenting project status, risks, trade-offs, and recommendations to senior and executive leadership. Experience working in a regulated quality environment, such as ISO 9001, ISO 13485, GMP, or comparable product development controls. Preferred Qualifications and Experience Bachelor's or advanced degree in Mechanical Engineering or a closely related engineering discipline. Experience leading life science instrument or analytical instrument launches. Experience with microfluidics, fluidics, cartridges, consumables, capillary electrophoresis, protein characterization, assay development, or with hardware-intensive products. Experience with design reviews, systems engineering, verification and validation, manufacturing transfer, pilot builds, and production scale-up. PMP or comparable project/program management certification. Knowledge, Skills, and Abilities Strong technical aptitude and the ability to engage engineering teams in detailed product-development discussions. Exceptional critical-path, dependency, risk, resource, and stakeholder management skills. Ability to influence cross-functional teams and senior stakeholders without direct authority. Strong analytical, problem-solving, and data-visualization capabilities. Ability to translate complex technical information into clear business recommendations and decisions. Excellent written, verbal, facilitation, and executive presentation skills. Demonstrated success leading through ambiguity, competing priorities, and resource constraints in a fast-paced environment. Ability to work independently while maintaining strong alignment across distributed teams and sites. Why Join Bio-Techne: We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield. We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA. We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more. We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging. We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table. Bio-Techne is an E-Verify Employer in the United States. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property. This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact hr@bio-techne.com for assistance.
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