Danaher Corporation Manager-Genomics/Reagents Manufacturing Science in Indianapolis, Indiana
Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you’ll help drive our vision of accelerating answers—and our commitment to excellence.
Beckman Coulter Life Sciences is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
Are you motivated by leading both people and projects? The Manager serves as the manufacturing & supply chain New Product Introduction (NPI) & sustaining program manager. Supports manufacturing operations with scientific expertise to ensure successful transfer of new products from development to manufacturing, ensuring robust manufacturing processes at commercialization; failure investigation of commercialized products; support processes to ensure performance within expected parameters!
Manages a team of manufacturing scientists and manufacturing/process engineers in parallel with executing complex reagent project(s) as a core team project manager; accountable for all operation-focused project delivery, quality and cost metrics through development projects and operations metrics.
Supports the NPI project manager(s) with complexity leveling initiatives for each NPI program, partnering with internal procurement and R&D teams to finalize formulation and packaging design
Provides technical guidance to associates on external raw material (e.g. biologics, chemicals) suppliers for front end manufacturing, scale-up capability, material qualification processes, design change impact and justification and quality/regulatory projects.
Ensures all Design History Files are in compliance with company and regulatory requirements (e.g. manufacturing process & test instructions provided by process engineering)
Works within a BL2 lab for execution of process characterization and/or scale-up experiment testing
BS degree in molecular biology, genetics, biochemistry, bio-engineering, engineering or a closely related field
9+ years experience or Masters Degree with 7+ years of related reagent manufacturing experience
1+ years of people management experience preferred
In-depth understanding of DNA/RNA viral extraction and clean-up reagent manufacturing/application practices and design control
Strong Multi-Project Management (e.g. Cost Modeling/Estimating; Project Scheduling & Management Tools such as MS Project, JIRA, Agile; capital equipment planning)
Project Management Certification preferred
ERP Interface (Oracle preferred)
GMP Document Creation/Review/Approval ( Master Device Records, Device History Records, SOPs)
Process & Test Method Validation (cleaning, mixing, filling)
Manufacturing Process Controls ( pFMEA, Statistical Process Control)Travel
Ability to travel as required (up to 25%).
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or firstname.lastname@example.org to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.