Process Group Chemist Lead

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.

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.

• 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

Required:

• 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

• This position is not currently eligible for visa sponsorship.

Preferred:

• B.S./B.A. Life/Applied Sciences or equivalent experience

• Minimum 5 years of related work experience in a GMP environment

Internal Partners:

Inventory Control, Process Engineering, Production, Planning, R&D, Quality/Documentation

The work environment characteristics are representative of a laboratory environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

Position requires ability to lift up to 20 lbs. on a regular basis. Up to 75% of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

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 $89,008.92 - $115,711.59 and is bonus eligible. 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.

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.

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