Staff Scientist II

MillenniumSoft Inc; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

MillenniumSoft Inc. seeks a Senior Staff Scientist II to lead preclinical safety and biocompatibility programs for medical devices in a GLP environment. The role focuses on regulatory-driven evaluation and collaboration with global teams in CPDT.

The position requires strong toxicology expertise, literature review, and the ability to design strategies, sponsor studies, and ensure EU MDR remediation as needed.

Qualifications

• Bachelor’s degree in toxicology or closely related field with 8+ years of pre-clinical medical device development experience; or Master’s with 5+ years; or PhD with 2+ years.
• Board certification in toxicology preferred (e.g., DABT, ERT)
• Experience in a GLP preclinical environment preferred.

Responsibilities

• Design, execute and interpret preclinical safety and biocompatibility studies per regulatory requirements.
• Serve as Sponsor Representative for biocompatibility and chemistry studies.
• Support EU MDR remediation efforts and generate biocompatibility evaluation reports.
• Maintain historical databases and perform data searches.

Skills

Biology

Toxicology

Biocompatibility

Analytical chemistry

Regulatory knowledge

Communication

Teamwork

Multitasking

Education

Bachelor’s degree in toxicology or closely related field

Master’s degree in toxicology or closely related field

PhD in toxicology or closely related field

Board certification (DABT, ERT)

Job description

Level of Experience : Senior Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

• This position will function within the Toxicology Unit of Corporate Preclinical Development and Toxicology (CPDT) and will support the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the BD CPDT Quality System.
• This position manages programs as the local SME to address biocompatibility and nonclinical safety of medical devices, pharmaceutical products, and other relevant products produced by client intended for registration and market by contributing to the development of evaluation strategies and programs and preparing and reviewing required documentation.
• The position will primarily support products in the MDS Business Segment(s) and project teams but may support other products and projects as required.

Position : Staff Scientist II

Location : San Diego, CA

Duration : 9 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Job Category : Research & Development

Level of Experience : Senior Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Job Description

• This position will function within the Toxicology Unit of Corporate Preclinical Development and Toxicology (CPDT) and will support the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the BD CPDT Quality System.
• This position manages programs as the local SME to address biocompatibility and nonclinical safety of medical devices, pharmaceutical products, and other relevant products produced by client intended for registration and market by contributing to the development of evaluation strategies and programs and preparing and reviewing required documentation.
• The position will primarily support products in the MDS Business Segment(s) and project teams but may support other products and projects as required.

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 client.
• 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.

Knowledge

• 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 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.