Johnson & Johnson is currently recruiting for a Senior Scientist of Microbiological Quality and Sterility Assurance (MQSA), supporting the Laminar business, located in Santa Rosa, CA. The position is eligible to participate in J&J Flex, working days both in the office and remote each week.
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Laminar, recently acquired by Johnson & Johnson, is a clinical stage medical device company advancing transseptal left atrial appendage (LAA) closure. The LAA is a small pouch in the left atrium of the heart that is a major contributor to thromboembolic stroke in patients with atrial fibrillation. It has developmental, ultra-structural, and physiological characteristics distinct from the left atrium proper. Growing incidence of atrial fibrillation and medical device developments have rapidly expanded the market.
In this role, the Senior Scientist of Microbiological Quality and Sterility Assurance (MQSA) will support Laminar and Biosense Webster by performing complex (such as study lead for sterilization validation) and routine tests (such as environmental monitoring sampling of the clean rooms, water and air) in compliance with the laboratory test methods and procedures in order to provide support of New Product Development (NPD), Manufacturing, Regulatory, and other operational partners. The scientist will lead and support the sterility assurance and microbiology aspects of functional, project, and validation program deliverables to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards as they pertain to medical devices. The scientist will also provide general guidance and mentorship to less senior team members to accomplish company and departmental objectives. The scientist will also be responsible and accountable for providing assurance that projects related to validation programs, new products, existing process modifications, and other technical projects related to microbiology and sterilization are completed according to regulation and procedure.
Key Responsibilities:
- As assigned, serve as a liaison between the Microbiological Quality & Sterility Assurance (MQSA) team and operations execution team during the development and selection of sterilization modalities, cycle development, and process validations.
- Work directly with the R&D teams to validated and transfer break-through technologies to enable future growth and innovations.
- Drive selection of sterilization modality, validation approaches and validation of the sterilization process for new products, and the sites for execution.
- Support microbiological aspects of the control and monitoring of the manufacturing environment, including controlled systems such as clean compressed air and purified water.
- Lead sterilization validations/revalidations studies or special projects as assigned.
- Communicates affairs related to the company or business opportunities to immediate supervisor and project teams, as applicable.
- Performs complex, routine tests in compliance with the laboratory procedures and tests methods to provide support to the timely delivery and product manufacturing to customers.
- Manage logistics of sterilization samples, review sterilization lot records (i.e., cycle run records, contract lab test reports, BI placement form), organize documents and submit (if applicable) for final release.
- As directed by the Staff Scientist of MQSA, take the lead in collaborating with other Department representatives (i.e., Calibration, De-contamination Lab, Packaging, Production, Engineering) for special studies or independently for routine functional issues.
- Leads in the performance and/or troubleshooting of test method and equipment validation and training.
Qualifications
- BS Degree in a biology, biochemistry, chemistry, microbiology, engineering, or a related field of study is required.
- A minimum of 4 years of experience with knowledge of medical device company operations, quality standards and GMP regulations of a medical device or pharmaceutical company
- Strong technical writing skills, the ability to manage multiple projects simultaneously and the ability to fluently change priorities based upon business need
- Experience with the use of ethylene oxide and at least one additional sterilization modality (e.g. radiation, moist heat, dry heat, etc.)
- Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility.
- Good interpersonal and organizational skills.
- Comfortable to work with multi-functional teams.
- Strong attention to detail.
Preferred:
- Master's Degree in science
- Experience with GMP audits, internal and relevant external audits
- Experience with overseeing biocompatibility studies
Other:
- Travel up to 15% may be required.
The anticipated base pay range for this position is $88,000- $141,450. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.