Posted on: May 16, 2023
Job Location: Newark CA - Newark, CA
Position Type: Full Time
Education Level: Master's Degree
Salary Range: Undisclosed
Travel Percentage: Negligible
Job Shift: Day
Job Category: Scientist
Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology and tissue-based diagnostics. Our core RNAscope technology is the world's first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. RNAscope is an ideal platform for developing the next generation of tissue-based companion diagnostics. We are committed to continued innovation to bridge the gap between basic research and clinical medicine to fulfill the promise of personalized medicine.
Salary Range: 90,000-165,00k based on experience
As the Leader of our Technical Operations team, you will lead a small team in collaborating with cross-functional groups to incorporate design changes for existing products as well as supporting design transfers for new products. In addition, you will work closely with R&D, Quality, Regulatory and Manufacturing counterparts to establish and maintain technical documentation in accordance with Company procedures and guidelines.
* Lead a small team responsible for all technical operations.
* Lead team member for operations technical support such as manufacturing support, solving MFG issues, handling product non-conformances, rework instructions, redlines and collaborate with QA/QC to secure the release of IVD product.
* Lead Operations Team member in design transfer of NPI (New Product Introductions). Works closely with R&D to develop manufacturing processes and actively participate in all aspect of new product development.
* Lead continuous improvement operations such as validation strategies, process validations, redlining batch records, participate invalidation activities etc.
* Provides technical support and expertise to the manufacturing operations on an as needed basis to tackle any problems and improve the manufacturing process.
* Focuses on critical deliverables and high-priority projects, acting as a hands-on resource where needed at the discretion of the manager to ensure on-time delivery of a high-quality product.
* Investigates and disposition product nonconformance's in conjunction with Quality, MFG and R&D team members.
* Experience developing & execution of manufacturing processes, writing procedures, and training manufacturing associates.
* Conduct proof of concept experiments.
* Initiates, execute and implement changes including but not limited to Engineering Changes and Deviations.
* MS/PhD in biology, chemistry, biochemical/process engineering, manufacturing sciences, or related field with minimum 5-7 years of industry experience.
* Experience managing others or acting in a team lead role for a minimum of 2-3 years.
* Demonstrated knowledge and expertise in product development, formulation, process development, and manufacturing, and quality control.
* Experience in product transfer, design control process, product stability, process/product validation, and specification setting.
* Experience in product transfer and manufacturing in compliance with ISO 13485 quality system.
* Experience in conducting technical troubleshooting and non-conformity/CAPA investigation, supporting post-market surveillance & customer complaints.
* Experience in tissue/cell-based assays such as immunohistochemistry and in situ hybridization.
* Excellent computer skills including Microsoft Excel and statistical data analysis programs such as Jump or Mini-tab.
Why Join Bio-Techne:
* We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
* We invest in our employees' financial futures through 401k matching and an employee stock purchase plan.
* We help our employees develop their careers through mentorship, promotional opportunities, training and development, 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 foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.
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.
Bio-Techne is an E-Verify Employer in the United States.
Keywords: Bio-Techne, Newark , Manufacturing Scientist, Other , Newark, California
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