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Senior Principal Biologist

Company: Edwards Lifesciences Corporation
Location: Irvine
Posted on: May 24, 2023

Job Description:

The Edwards Quality Lab has a prestigious Senior Principal Biologist opportunity for a lead technical expert in pre-clinical and in process biocompatibility and toxicology studies.

Position is onsite (80% or 4 days per week in office), based out of the Irvine Corporate Campus location. Comprehensive relocation benefits available for eligible out of area candidates.

Key Role Responsibilities:
---Lead laboratory operations activities including maintaining work schedules to drive compliance, policy and procedures and lead qualification of all laboratory instrumentation including complex equipment and validate complex test methods OR Serve as a toxicologist or technical expert in ISO 10993. Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams while keeping informed of changes in the science of biocompatibility (e.g., (EQL) EW Quality Laboratory study directors, (E/L) extractable and leachable)
---Train, coach, and guide lower level employees on complex equipment and test methods, assess work techniques and provide feedback on policies and procedures
---Key technical contact in providing strategy on root cause analysis for process product failures, non-conformances, and CAPA
---Lead complex process improvement projects (e.g., BEST, Lean) and work with team to provide solutions
---Other incidental duties

Required Education and Experience:

  • Bachelor's Degree in Biology or related field, plus minimum ten (10) years relative experience required
  • Master's Degree in Biology or related field, plus minimum eight (8) years of relative experience required
  • Ph.D. in Biology or related field , plus minimum six (6) years related experience required
  • Professional experience as a Sr Study Director or SME Scientist in the medical device or research industry highly preferred

    Additional Skills and Expectations:

    ---Proven subject matter expert knowledge and understanding of biology principles, theories and concepts
    ---Expert knowledge of laboratory equipment (e.g., microscope, spectrophotometer, flow cytometer, analytical balance, centrifuge)
    ---Extensive knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP/QSIT)
    ---Experienced in project management and presentations to Sr Stakeholders
    ---Excellent problem-solving, analytical and critical thinking skills
    ---Demonstrates professional communication and interpersonal relationship skills including relationship management skills with ability to influence change and drive achievement of objectives
    ---Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
    ---Ability to manage confidential information with discretion
    ---Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
    ---Thrives in a collaborative team environment, including representing organization as key technical contact on contracts and projects
    ---Ability to interact with senior external representatives (e.g., regulatory agencies, FDA, DEKRA, TUV, MHLW) on significant technical matters often requiring coordination between organizations
    ---Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

    Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

    For California, the base pay range for this position is $123,000 to $174,000 (highly experienced).

    The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

    Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

    COVID Vaccination Requirement

    Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

Keywords: Edwards Lifesciences Corporation, Irvine , Senior Principal Biologist, Other , Irvine, California

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