Staff Scientist II - Urgent Need - Millenniumsoft : Job Details

Join to apply for the Staff Scientist II - Urgent Need role at MillenniumSoft Inc

5 months ago Be among the first 25 applicants

Join to apply for the Staff Scientist II - Urgent Need role at MillenniumSoft Inc

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 IILocation : Franklin Lakes, NJDuration : 9 MonthsTotal Hours/week : 40.001st ShiftClient : Medical Devices CompanyJob Category : Research & DevelopmentLevel of Experience : Senior LevelEmployment 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.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionResearch, Analyst, and Information Technology
• IndustriesStaffing and Recruiting

Referrals increase your chances of interviewing at MillenniumSoft Inc by 2x

Get notified about new Staff Scientist jobs in Franklin Lakes, NJ.

Associate Investigator (Part-Time), Level I

New York City Metropolitan Area 1 hour ago

Assistant Scientist- Pharmacological SciencesFBI Special Agent: Healthcare/Medical Expertise

Brooklyn, NY $99,461.00-$128,329.00 1 hour ago

Clinical Research Assistant I-NeruosurgerySpecial Agent: Healthcare Services /Medical Background

New York City Metropolitan Area $99,461.00-$128,329.00 41 minutes ago

Suffern, NY $120,000.00-$130,000.00 56 minutes ago

Associate Researcher- Oncological SciencesAssociate Researcher- Oncological Sciences

New York, NY $145,000.00-$195,000.00 1 day ago

Assistant Director of DNA Investigations

New York City Metropolitan Area 1 hour ago

Clinical Research Associate I - Cardiology

New York, NY $50,000.00-$50,000.00 1 day ago

Associate Researcher- Immunology and Immunotherapy

Florham Park, NJ $36.00-$37.00 5 hours ago

New York, NY $85,290.00-$111,990.00 20 hours ago

Scientist II, UberEats Search (Causal Inference)Environmental Engineer or Scientist - Entry LevelClinical Research Coordinator I-PediatricsAssociate Researcher I- Pharmacological SciencesClinical Research Coordinator II-Population Health Science & Policy (Adolescent Empowerment & Maternal Health

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr