Support device organization with expertise on biocompatibility evaluations (ISO 10993-1) and more ... The role is hybrid, option for remote work may be available
Support device organization with expertise on biocompatibility evaluations (ISO 10993-1) and more ... The role is hybrid, option for remote work may be available
Senior Principal Scientist
Thousand Oaks, CA · On-site +1
Support device organization with expertise on biocompatibility evaluations (ISO 10993-1) and more ... The role is hybrid, option for remote work may be available What we expect of you We are all ...
Senior Principal Scientist
Thousand Oaks, CA · On-site +1
Support device organization with expertise on biocompatibility evaluations (ISO 10993-1) and more ... The role is hybrid, option for remote work may be available What we expect of you We are all ...
Remote Biocompatibility Scientist information
What is a remote biocompatibility scientist?
A Remote Biocompatibility Scientist is a professional who evaluates the compatibility of medical devices and materials with biological systems, such as human tissues, while working remotely. They are responsible for assessing the safety of materials used in medical devices to ensure they don't cause adverse reactions when in contact with the body. Their work involves reviewing scientific data, conducting risk assessments, and preparing documentation for regulatory submissions, often collaborating with interdisciplinary teams from a remote location. This role requires expertise in toxicology, biology, and regulatory standards such as ISO 10993.
How does a remote biocompatibility scientist typically collaborate with cross-functional teams in a virtual environment?
As a Remote Biocompatibility Scientist, you will frequently collaborate with regulatory, engineering, and quality assurance teams through virtual meetings and collaborative platforms. Effective communication is key, as you’ll need to interpret biocompatibility data, provide guidance on regulatory submissions, and align testing strategies with product development goals. Most companies use project management tools and regular video conferences to ensure smooth coordination and timely updates. Building clear documentation and maintaining proactive communication help overcome the challenges of remote work and ensure successful team outcomes.
What are the key skills and qualifications needed to thrive as a remote biocompatibility scientist, and why are they important?
To thrive as a Remote Biocompatibility Scientist, you need a strong background in biomedical sciences, toxicology, or materials science, usually supported by a relevant degree and experience with ISO 10993 standards. Familiarity with laboratory information management systems (LIMS), biocompatibility testing methods, and regulatory documentation tools is typically required. Excellent analytical thinking, attention to detail, and effective written communication are vital soft skills for collaborating remotely and preparing clear reports. These skills ensure accurate biocompatibility assessments, regulatory compliance, and smooth teamwork in a remote work environment.
What is the difference between Remote Biocompatibility Scientist vs Remote Regulatory Affairs Specialist?
| Aspect | Remote Biocompatibility Scientist | Remote Regulatory Affairs Specialist |
|---|---|---|
| Required Credentials | Degree in life sciences, certification in biocompatibility testing | Degree in life sciences or law, regulatory certifications (e.g., RAC) |
| Work Environment | Laboratories, research settings, medical device companies | Regulatory agencies, medical device or pharmaceutical companies |
| Industry Usage | Medical devices, implants, biomaterials | Medical devices, pharmaceuticals, healthcare products |
| Common Search/Comparison | Yes | Yes |
The Remote Biocompatibility Scientist focuses on testing and evaluating the safety of medical materials and devices, ensuring they are biocompatible. In contrast, the Remote Regulatory Affairs Specialist manages regulatory submissions and compliance for medical products. While both roles require knowledge of industry standards, their core responsibilities and work environments differ significantly.
What are the most commonly searched types of Biocompatibility Scientist jobs in California?
The most popular types of Biocompatibility Scientist jobs in California are:
What are popular job titles related to Remote Biocompatibility Scientist jobs in California?
For Remote Biocompatibility Scientist jobs in California, the most frequently searched job titles are:
What job categories do people searching Remote Biocompatibility Scientist jobs in California look for?
The top searched job categories for Remote Biocompatibility Scientist jobs in California are:
What cities in California are hiring for Remote Biocompatibility Scientist jobs?
Cities in California with the most Remote Biocompatibility Scientist job openings:
Senior Principal Scientist - Thousand Oaks, CA
Thousand Oaks, CA • On-site, Remote
Full-time
Posted 29 days ago
Key responsibilities
Prepare toxicological assessments of leachable and extractables testing data related to manufacturing, containers, and drug-device products.
Support device organization with biocompatibility evaluations and assessments of leachable substances for medical devices.
Classify drug candidates into Occupational Exposure Bands and derive Occupational Exposure Limits to support worker safety.
Job description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is On-Site at the location detailed in the job post.
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Principal Scientist
What you will do
Let's do this. Let's change the world! We are seeking an experienced toxicologist in the Product Stewardship group within our Environment, Health, Safety and Sustainability (EHSS) organization. This position has a broad reach and supports:
bringing new drugs to market, and
ensuring patient and staff safety
In this role you will mature core toxicology programs to manage patient safety and EHSS risks of Amgen products, including those from drugs, manufacturing materials, primary containers, and drug-delivery device combination products, as they advance from development to commercialization, and post-approval. Primary role includes performing CMC/Quality toxicology assessments and supporting Occupational toxicology. Responsibilities include:
Prepare toxicological assessments of leachable and extractables testing data as they relate to single-use manufacturing, primary drug containers, delivery devices and drug-device combination products.
Support device organization with expertise on biocompatibility evaluations (ISO 10993-1) and more specifically on leachable substances (ISO 10993-17) for medical devices.
Prepare and/or manage toxicology assessments of process reagents and excipients used in Amgen drug development processes and formulations.
Prepare product quality toxicology assessments to support non-conformances and product complaints.
Conduct or assist with patient and/or worker safety risk assessments.
Classify drug candidates into Occupational Exposure Bands (OEBs) for worker safety and categorize hazards according to the Globally Harmonized Standard (GHS) for Safety Data Sheets (SDSs) and labeling to support worker safety.
Derive Occupational Exposure Limits (OELs) for drug candidates and documented in product Hazard Assessment Monographs, to support worker safety.
Monitor scientific developments and conduct desktop research including literature searches and critically evaluate and summarize scientific information and government regulations.
Support scientific work including regulatory compliance, trade associations, and professional organizations relevant to work assignments.
Coordinate Amgen EHSS contributions for influencing external scientific and regulatory activities and key initiatives such as ICH M7 (mutagenic impurities) and updates to EU GMPs (setting health-based limits for pharmaceuticals).
The role is hybrid, option for remote work may be available
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Principal Scientist
What you will do
Let's do this. Let's change the world! We are seeking an experienced toxicologist in the Product Stewardship group within our Environment, Health, Safety and Sustainability (EHSS) organization. This position has a broad reach and supports:
bringing new drugs to market, and
ensuring patient and staff safety
In this role you will mature core toxicology programs to manage patient safety and EHSS risks of Amgen products, including those from drugs, manufacturing materials, primary containers, and drug-delivery device combination products, as they advance from development to commercialization, and post-approval. Primary role includes performing CMC/Quality toxicology assessments and supporting Occupational toxicology. Responsibilities include:
Prepare toxicological assessments of leachable and extractables testing data as they relate to single-use manufacturing, primary drug containers, delivery devices and drug-device combination products.
Support device organization with expertise on biocompatibility evaluations (ISO 10993-1) and more specifically on leachable substances (ISO 10993-17) for medical devices.
Prepare and/or manage toxicology assessments of process reagents and excipients used in Amgen drug development processes and formulations.
Prepare product quality toxicology assessments to support non-conformances and product complaints.
Conduct or assist with patient and/or worker safety risk assessments.
Classify drug candidates into Occupational Exposure Bands (OEBs) for worker safety and categorize hazards according to the Globally Harmonized Standard (GHS) for Safety Data Sheets (SDSs) and labeling to support worker safety.
Derive Occupational Exposure Limits (OELs) for drug candidates and documented in product Hazard Assessment Monographs, to support worker safety.
Monitor scientific developments and conduct desktop research including literature searches and critically evaluate and summarize scientific information and government regulations.
Support scientific work including regulatory compliance, trade associations, and professional organizations relevant to work assignments.
Coordinate Amgen EHSS contributions for influencing external scientific and regulatory activities and key initiatives such as ICH M7 (mutagenic impurities) and updates to EU GMPs (setting health-based limits for pharmaceuticals).
The role is hybrid, option for remote work may be available
About Veteran Resources
Sourced by ZipRecruiter
Industry
Technology, communication and media
Company size
11 - 50 Employees
Headquarters location
Walnut Creek, CA, US
Year founded
2008