Scientist II, IHC Research and Development

Our Company

Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry Instrumentation and the full range of reagents for immunohistochemistry and molecular lab testing. Biocare is the market leader in simultaneous Multiplex IHC tests which provide increased confidence at critical diagnostic decision points, impacting patient therapy while accelerating turnaround time.

The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. Biocare medical is headquartered and has manufacturing facilities in California and has a global distribution network.

 

Summary/Objective

The Scientist II, IHC R&D functions with minimal supervision and guidance in support of the IVDR Remediation Project team and within the Research and Development Laboratory. The Scientist II, IHC R&D supports and manages testing activities for IVDR Technical Documentation by writing, reviewing, and approving associated testing documents as well as grading slides and incorporating findings and insights into conclusions. The Scientist II, IHC R&D is also responsible for writing, reviewing, and approving Technical Documentation that requires scientific knowledge and qualifications, including but not limited to risk management files, datasheets, scientific validity, performance evaluation plans, and reports.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Performs IHC, in situ hybridization (ISH), fluorescence in situ hybridization (FISH) procedures and daily laboratory functions.
• Performs research projects requiring implementation of design files. Writes data sheets and interprets experimental testing results.
• Performs literature searches for experimental and scientific designs pertaining to their work. 
• Writes, reviews, and edits technical documentation for IVD products. 
• Attends seminars, webcasts and workshops as well as generate abstracts and publications.
• Knowledgeable in imaging analysis algorithms.
• Collaborates with universities as well as alpha and beta sites. Some travel may be necessary.
• Coordinates participation in NordiQC module testing. Run NordiQC protocols.
• Reviews test forms and other user editable forms of fellow R&D staff members as needed to ensure accuracy of documents prior to submission.
• Other duties as assigned by Management.

Competencies

• Advanced degree (Ph.D. and/or M.D.) in the field of biochemistry, molecular biology, immunology, oncology, and/or pathology.
• One to five years industrial and academic post-doctoral education experience.
• Certification as a Histotechnologist or other relevant certification by the ASCP is a plus.
• Must be able to write clear, understandable documentation with effective presentation of information.
• High level of verbal communication skills.
• Exceptional proofreading skills with good attention to details.
• Basic understanding of ISO and GMP and its application to the job.
• Ensures that all SOP’s are followed and recommend Quality Improvement Measures.
• Accuracy and attention to details.
• Adheres to Quality Standards and continual improvement, root cause analysis.
• Must be independent and require minimum supervision.

Compensation Range

• $125,000 - $150,000  annual

Expected Hours of Work

• 8:30 a.m. to 5:30 p.m. Monday – Friday (unless otherwise determined by departmental needs that may include earlier or later starting and ending hours. ). This position may require extended weekday or weekend hours depending on business needs.

Full-Time Positions Offer

• Company Sponsored Health Insurance - medical, dental, vision,
• Company Sponsored Life Insurance
• Voluntary Benefits
• Retirement plan - 401(k)
• PTO
• Paid Holidays

BioCare Medical values the diversity of individuals, ideas, and perspectives, and what they bring to the workplace. We know that our people represent the future of the company, so we only hire the best from around the world. Applications from all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or status as a Protected Veteran.

All inquiries strictly confidential.