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MillenniumSoft Inc · 4 months ago

Staff Scientist II

San Diego, CA

Full-time

Onsite

Mid, Senior Level

2+ years exp

MillenniumSoft Inc is a Medical Devices Company seeking a Staff Scientist II to work within the Toxicology Unit of Corporate Preclinical Development and Toxicology. The role involves managing programs related to biocompatibility and nonclinical safety of medical devices and supporting the execution of laboratory investigations in accordance with GLP regulations.

Staffing & Recruiting

No H1B

U.S. Citizen Only

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

Qualification

ToxicologyBiocompatibilityAnalytical ChemistryGLP ExperienceMedical Device DevelopmentScientific CommunicationMultitaskingComputer SkillsInterpersonal SkillsTeam OrientedCustomer Focus

Required

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)

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)

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