Location: Irvine,CA, USA
We are seeking a highly skilled and motivated MSAT (Manufacturing Science and Technology) Scientist to join our Quality Control Manufacturing team. The successful candidate will be responsible for ensuring the quality and consistency of our manufacturing processes and products, providing technical expertise, and driving continuous improvement initiatives. This role is critical in maintaining high standards of product quality and regulatory compliance.
How You'll Make An Impact:
* Develop and optimize manufacturing processes to ensure product quality and consistency.
* Provide technical support for troubleshooting and resolving manufacturing issues.
* Conduct risk assessments and implement mitigation strategies for manufacturing processes.
* Collaborate with cross-functional teams to design and execute process validation studies.
* Analyze process data to identify trends, deviations, and areas for improvement.
* Develop and maintain process documentation, including standard operating procedures (SOPs), batch records, and validation protocols.
* Support the transfer of new processes and technologies from R&D to manufacturing.
* Ensure compliance with regulatory requirements and industry standards (e.g., FDA, EMA, GMP).
* Lead or participate in investigations of quality incidents, deviations, and non-conformances.
* Provide training and guidance to manufacturing personnel on new processes and technologies.
* Contribute to the development and implementation of quality control strategies and metrics.
What You Bring:
* Bachelor's degree in Chemistry, Biochemistry, Biotechnology, or a related field. Advanced degree (Master's or Ph.D.) preferred.
* Minimum of 7-10 years of experience in a manufacturing science and technology role within the pharmaceutical or biotechnology industry.
* Proficiency in process development, optimization, and validation. Experience with analytical techniques and quality control methods. Knowledge of GMP regulations and quality systems.
* Strong analytical and problem-solving skills. Ability to troubleshoot complex manufacturing issues and implement effective solutions.
* Excellent verbal and written communication skills. Ability to convey technical information clearly and effectively to various stakeholders.
* Demonstrated ability to work collaboratively in a cross-functional team environment. Strong interpersonal skills and the ability to build effective working relationships.
* High attention to detail and commitment to quality.
* Experience with statistical analysis and process control software.
* Familiarity with regulatory submission processes and requirements.
* Certification in Lean Six Sigma or other process improvement methodologies.
* Experience with technology transfer and scale-up of manufacturing processes.
Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.
Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more!
Compensation: The estimated base salary range for this position is $91,500 - $125,900 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is also eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.
Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
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Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.