Process Group Chemist Lead

QuidelOrtho • Carlsbad, CA

2d • Onsite

About The Position

The 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 At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Process Group Lead. This role is responsible for coordinating chemistry manufacturing activities which may include but are not limited to the preparation of buffers, assay reagents, standards and controls, complexes and conjugates, and antibody purification. This position is also responsible for ensuring that all employees follow all associated QSR and ISO regulations, manufacturing instructions, operating procedures and corporate policies. This position will be onsite in Carlsbad, CA.

Requirements

• Demonstrated leadership capabilities
• Proficient in data analysis, data summary, and presentation
• General computer knowledge and experience with EXCEL, Word, and equivalent programs
• Advanced working knowledge of LN
• Leadership skills
• Demonstrated knowledge of internal customer/supplier relationships in decision making
• Good interpersonal, communication, verbal, written, and organizational skills
• Technical expertise in the specific product
• Competent in all manufacturing procedures related to the specific product
• Basic algebraic, statistical and mathematical skills
• Specific computer knowledge related to the ERP program
• Laboratory skills, such as protein purification, antibody conjugation, solution preparation, ELISA experience, assay development skills, knowledge of experimental design etc.
• Knowledge of QSR’s and ISO 13485
• B.S./B.A. Life/Applied Sciences or equivalent experience
• Minimum 5 years of related work experience in a GMP environment

Responsibilities

• Develops the weekly production schedule and allocates labor based on skill level
• Coordinates all chemistry manufacturing activities including labor and material allocation so that production standards are met
• Ensures the accuracy of material and labor transactions into LN
• Trains and coaches employees to achieve compliance to all QSR and ISO regulations, manufacturing instructions, procedures, and company policies
• Ensures that training records are accurately maintained and current
• Assists with the transfers of new products to manufacturing including validation of equipment and/or processes
• Initiates document and procedural changes utilizing the Engineering Change Order (ECO) system
• Executes additional tasks as required by the Chemistry Manufacturing leadership
• Identifies and articulates complex problems and assumes a coaching role to less experienced personnel

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level