Address
Form of workThe Opportunity
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
The Role:
As the company continues to grow, we are seeking a Tech Transfer Lead for new product introduction in our building 313 facility. This position will primarily support QuidelOrtho's MicroSlide and MicroTip products. This individual will efficiently introduce products/processes into Operations, ensure manufacturability, optimize unit manufacturing cost, and align Design and Operations Requirements.
This is an on site position in Rochester, NY. A hybrid schedule may be considered.
The Responsibilities:
The Individual:
Required:
Preferred:
The Key Working Relationships:
Internal Partners: Project Managers, Product Managers, Technical Leads, R&D Laboratory Specialists, Design Quality Team, Operations Team, Quality Engineering Team, Validation Team
External Partners: Suppliers
The Work Environment:
The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of operational goals. Position requires ability to flexibly spend time on the desk, analyzing data, in meetings as well as hand-on as needed. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.
Salary Transparency
The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $71,000 - $128,000 and is eligible a bonus. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
Equal Employment Opportunity
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.
#LI-AP1
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
The Role:
As the company continues to grow, we are seeking a Tech Transfer Lead for new product introduction in our building 313 facility. This position will primarily support QuidelOrtho's MicroSlide and MicroTip products. This individual will efficiently introduce products/processes into Operations, ensure manufacturability, optimize unit manufacturing cost, and align Design and Operations Requirements.
This is an on site position in Rochester, NY. A hybrid schedule may be considered.
The Responsibilities:
- Serve as Operations' advocate on multiple Program Teams to provide technical input on processes as affected by product design direction.
- Assist in developing Program timelines, Ops resource & budget requirements and other project planning inputs.
- Coordinate various Operations groups' activities/deliverables and resolve issues to meet project timeline.
- Ensure that the Tech Transfer Team and other Operations support groups provide technical support to resolve product/process issues and optimize production.
- Work within documented procedures for Change Management, Verification, Validation. Has accountability to the Global Project Leader, Program Managers and Operations to ensure that Key Performance Indicators (cost, quality, and delivery) are achieved.
- Lead communications between Engineering, Operations, R&D, QRC and other key stakeholders in the project.
- Develop the Operations Plan and ensure completion of Product Development Process (PDP)-related deliverables in new product Verification, Validation and Launch.
- Understand Operations processes and requirements to assess product designs within those requirements.
- Collaborate with R&D partners to ensure thorough knowledge transfer to Operations. Includes bi-directional "witness" events.
- Coordinate / develop operations documentation including FMEAs, validation plans, reports, SOPs, raw materials specifications & inspection, in-process & release testing, Environmental Tracking, etc.
- Determine scale up requirements and Operations capability to meet future production needs.
- Lead or support training activities as required.
- Conduct Root Cause Investigations through Corrective and Preventive Action implementation.
- Perform additional work related duties as assigned.
The Individual:
Required:
- Bachelors degree (Engineering, Chemistry, Biochemistry, Biology, or scientific discipline
- 7-9 years relevant experience
- Knowledge of Operations / Manufacturing / Quality release processes and systems
- Experience working in an agile environment and coordinating cross functional resources
- Ability to resolve conflicts between Design Requirements and Operational Requirements
- Efficient use of common applications, such as MS Office
- Project management skills
Preferred:
- Masters degree in related scientific discipline
- Experience with Lean Manufacturing, Six Sigma and Mistake Proofing
- Experience with MS Project or other planning tools
- cGMP and external audit experience (GMED, FDA, etc.)
- Knowledge of QuidelOrtho's products and quality system
- Multi-disciplined validation experience (Process, Product, Software, Method).
The Key Working Relationships:
Internal Partners: Project Managers, Product Managers, Technical Leads, R&D Laboratory Specialists, Design Quality Team, Operations Team, Quality Engineering Team, Validation Team
External Partners: Suppliers
The Work Environment:
The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of operational goals. Position requires ability to flexibly spend time on the desk, analyzing data, in meetings as well as hand-on as needed. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.
Salary Transparency
The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $71,000 - $128,000 and is eligible a bonus. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
Equal Employment Opportunity
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.
#LI-AP1
