Biology Scientist
Job Title: Biology Scientist II
Location: San Diego, CA, USA, 92130.
Duration: 12 Months.
Responsibilities
For many roles at this client, assignment is contingent upon the Employer of Record’s receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, weekly testing for COVID-19 may be available instead of vaccination. Requests for accommodation will be considered pursuant to applicable law.
Location: San Diego, CA, USA, 92130.
Duration: 12 Months.
Responsibilities
- Contribute as local SME to the design, execution and interpretation of preclinical safety, biocompatibility, analytical chemistry, and toxicological evaluation strategies and programs according to relevant regulatory requirements; including review of literature and assessment of compliance.
- Collaborate with CPDT SMEs, BD project teams, business unit regulatory affairs staff, R&D staff and outside suppliers as required to help define product testing requirements and coordinate with the project team to provide CPDT deliverables.
- Serve as Sponsor Representative for biocompatibility and chemistry studies and contribute to design, execution, and interpretation of preclinical, biocompatibility, chemistry and toxicological evaluation programs for medical devices within BD.
- Support EU MDR remediation efforts, create biocompatibility evaluation reports, and conduct testing as needed to ensure compliance under the EU MDR.
- Maintain historical databases and perform searches of historical data, as needed.
- Education/Experience Bachelor’s degree in toxicology or a closely related field and a minimum of 8 years of pre-clinical medical device development experience OR Master’s degree in toxicology or a closely related field and a minimum of 5 years pre-clinical medical device development experience OR PhD Degree in toxicology or a closely related field and a minimum of 2 years pre-clinical medical device development experience years relevant experience or a combination of equivalent education and relevant experience.
- Board certification in toxicology preferred (e.g., DABT, ERT)
- Experience in a GLP preclinical environment preferred.
- Working knowledge of computers (Word, Excel, Access, PowerPoint, SharePoint).
- Skills/Abilities A broad background in biology/biocompatibility, toxicology and analytical chemistry including familiarity with recent methodologies and evaluation techniques (i.e., ISO 10993 and related guidance).
- Experience in a United States or EU medical device setting is preferred.
- Ability to communicate and work effectively with national and international, internal, and external teams.
- Must be able to multitask and operate effectively within a diverse work environment. Must be team oriented and have strong interpersonal skills and customer focus while functioning independently as an SME. Must have excellent scientific written and verbal communication skills.
For many roles at this client, assignment is contingent upon the Employer of Record’s receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, weekly testing for COVID-19 may be available instead of vaccination. Requests for accommodation will be considered pursuant to applicable law.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Other -
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Intellectt Inc by 2x
See who you knowGet notified about new Biology Scientist jobs in San Diego, CA.
Sign in to create job alertSimilar jobs
People also viewed
-
Biologist I
Biologist I
-
Biologist
Biologist
-
Biologist 0 3 years
Biologist 0 3 years
-
Biologist
Biologist
-
As-Needed Biologist
As-Needed Biologist
-
Biologist
Biologist
-
Biologist (Entry)-Biological R&D-R&D-CS-US
Biologist (Entry)-Biological R&D-R&D-CS-US
-
Biologist
Biologist
-
Microbiologist/Molecular Biologist
Microbiologist/Molecular Biologist
-
Biologist
Biologist
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub