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
The Associate Molecular Biochemist plays a crucial role in GMP molecular chemistry production and in-process quality testing activities. Responsibilities include molecular biochemistry production and quality testing. The Associate Molecular Biochemist will perform routine procedures with senior staff oversite. Some collaboration with senior staff on investigations and troubleshooting is expected.
This role is located in Athens, Ohio.
The Responsibilities
- Execute GMP manufacturing and QC protocols with supervision.
- Plan and conduct experiments with the guidance of senior staff, analyzing data and making recommendations for process optimization.
- Maintain production inventory and laboratory instruments to support continuous MDx chemistry production and Quality Control.
- Identify issues with routine procedures, troubleshoot product performance issues, and implement corrective actions.
- Document detailed GMP records and laboratory notebooks accurately to meet internal and external regulatory standards.
- Support Process Validation, stability studies and post-market supplemental studies as needed.
- Work on problems of a diverse scope and solve technical problems encountered in routine procedures as they arise.
- Assist in developing specifications, QC standards, and test methods to ensure product quality and consistency.
- Assist customer complaint investigations.
- Collaborate in team environment and maintain effective communication with stakeholders.
- Ensure a safe working environment by adhering to safety protocols and promoting a culture of safety within the team.
The Individual
Required
- BA/BS or MA/MS in life sciences-related field.
- 1-3 years of relevant industrial, laboratory or collegiate experience or demonstrated mastery of all relevant and associated production and quality related skills for the role.
- Background in chemistry, biochemistry, molecular biology, virology, immunology, or related field
- Knowledge of assay development, process development, problem-solving, and statistical experimental design
- Protein optimization laboratory research experience preferred, particularly in recombinant protein expression.
- Ability to complete activities per communicated timelines.
- Good organizational skills and an ability to perform multiple tasks simultaneously required.
- Good ability to prepare and present technique data
- Strong analytical and problem-solving skills.
- Ability to work within cross-functional teams.
- Excellent communication skills (verbal and written)
- Must exhibit professionalism and maturity and display desire to succeed, be self-motivated and proactive
- Appropriate computer skills (e-mail, graphing software, word processing) required.
- Must possess ability to develop experimental plans and execute associated activities per communicated timelines.
Preferred
- Hands on expertise performing protein purification (column-based methods, gravity flow). Experience with AKTA instrument
- Experience with general molecular biology skills such as PCR amplification, primer design, gel electrophoresis and bacterial transformation
- Working knowledge of GMP and ISO 13485 quality system regulations
The Key Working Relationships
Internal Partners
Manufacturing, QA/QC, Purchasing, R&D, Tech Support and Engineering
The Work Environment
Combination of laboratory and office environment. Position requires ability to lift up to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) 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. Personal protective equipment is required as posted.
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 their 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 .
