Planet Pharma · 2 days ago
CMC Scientist
United States
Full-time
Remote
Mid Level
$43/hr - $53/hr
3+ years exp
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Responsibilities
Knowledgeable in biocompatibility standards and requirements for marketing medical devices globally (USA, Europe and other countries)
Collaborate effectively with team members from various disciplines globally to develop biocompatibility testing strategies to qualify medical device product
Review, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility compliance and appropriate Regulatory and Quality (e.g. MDR) compliance.
Work closely with supervisor to determine potential regulatory risks associated with proposed biocompatibility test strategy and reviewing test protocols from contract labs
Collaborate with Biocompatibility team members for alignment with testing strategies
Coordinate testing through outside laboratories by preparing test samples, submission forms, monitor chemical testing or biological studies, review reports generated by outside laboratories and generate final summary report
Author Toxicological Risk Assessment Reports for extractables/leachables, Biocompatibility Risk Assessment Reports for CE Mark and US FDA 510 K Submissions
Work must show accuracy, attention to detail, completeness of documentation, and be well organized.
Support interactions with regulatory bodies related to available biocompatibility data for a product
Support development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files
Appropriately prioritize assignments to meet project schedules
Responsible for meeting scope and timelines of Biocompatibility deliverables to project teams
Qualification
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Required
Knowledgeable in biocompatibility standards and requirements for marketing medical devices globally (USA, Europe and other countries)
Collaborate effectively with team members from various disciplines globally to develop biocompatibility testing strategies to qualify medical device product
Review, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility compliance and appropriate Regulatory and Quality (e.g. MDR) compliance
Work closely with supervisor to determine potential regulatory risks associated with proposed biocompatibility test strategy and reviewing test protocols from contract labs
Collaborate with Biocompatibility team members for alignment with testing strategies
Coordinate testing through outside laboratories by preparing test samples, submission forms, monitor chemical testing or biological studies, review reports generated by outside laboratories and generate final summary report
Author Toxicological Risk Assessment Reports for extractables/leachables, Biocompatibility Risk Assessment Reports for CE Mark and US FDA 510 K Submissions
Work must show accuracy, attention to detail, completeness of documentation, and be well organized
Support interactions with regulatory bodies related to available biocompatibility data for a product
Support development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files
Appropriately prioritize assignments to meet project schedules
Responsible for meeting scope and timelines of Biocompatibility deliverables to project teams
Understanding of principles, and techniques of toxicology and biocompatibility
3-5 years of experience in medical device industry or biocompatibility research organization working on biocompatibility of medical device
Deep working knowledge of ISO 10993 standards for biocompatibility
Ability to coordinate work through outside service laboratories (e.g. extractables/leachables testing and non-clinical safety studies)
Experience with sample preparation/extraction/ separation techniques for material analyses
Experience in polymers, analytical chemistry
Experience in instrumentation analysis – e.g. FTIR, HPLC, GC, IC, ICP-MS, GC/MS spectroscopic techniques
Experience interpreting laboratory data and working with mathematical concepts relevant to chemical or biological testing
Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines and writing technical reports, toxicological risk assessment or biocompatibility evaluations
Experience working in Design Control environment; Auditing Skills, Knowledge of quality systems and regulatory submissions
Strong oral and written communication skills
Ability to multitask and track multiple projects at various stages
Attention to detail; Critical thinking skills to Interpret available data and recommend strategies to resolve technical challenges
Strong computer and general software skills
Bachelors Degree in Biological Sciences or Toxicology or Chemistry with courses in Life Sciences
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (2)
2021 (8)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase
