Lead Biocompatibility Engineer / Lead Toxicologist

Lawrence Harvey

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Job ID :

14282


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

PhD


Address 1 :

North America,--California,California,


Key Skills :

Lead Biocompatibility Engineer / Lead Toxicologist


Salary :

Negotiable


Date Posted :

20 Feb, 2019



Company Name :

Lawrence Harvey


Location1 :

California




Job Category :

Pharma Manufacturing Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Responsibilities and Accountabilities

* Be accountable for robust biocompatibility evaluation outcomes with technical leadership and sound strategies for successful regulatory submissions.
* Deliver biocompatibility assessments and biocompatibility evaluation plan and report complying with applicable biological evaluation standards and FDA guidance documents within a risk-based framework.
* Maintain a knowledge of applicable external standards and regulatory requirements for the biological safety of medical devices and mentor the development of these knowledge in others.
* Review biocompatibility test results to determine adequacy of data to meet requirements for the biological effects, and utilize problem solving skills and technical knowledge to troubleshoot unexpected results.
* Manage multiple projects requiring biocompatibility evaluation ensuring timely completion of required tasks to meet project schedules.
* Collaborate and clearly communicate with internal and external stakeholders (e.g. Contract Research Organizations (CROs)) to ensure appropriate planning and execution of risk assessments and required testing.
* Support regulatory submissions to global regulatory agencies to elaborate on the product biocompatibility strategy and data in response to additional information requests.
* Collaborate with Global Supplier Alliance (GSA), engineering teams, and external vendors to procure material specifications and safety data sheets in order to assess safety of products.
* Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of biological safety assessments and test plans/reports.
* Perform gap analysis of external standards, regulatory requirements and guidance associated with biological safety evaluation, and minimize the negative impact of such gaps on the products and business.
* Provide technical mentoring and training to the broader audience within the organization as required on process and product engineering.



Position Specific Skills and Challenges

* Extensive knowledge of FDA and ISO 10993 biological safety requirements and test methods including chemical characterization, and Good Laboratory and Good Manufacturing practices (GLP and GMP).
* Ability to interact at the highest professional manner with all organizational levels.
* Adaptation of business process to align with industry standards and best practices.
* Excellent written and verbal communication skills to effectively interact with and contribute constructively to a global team environment internally and externally.
* Good interpersonal skills and function successfully in a collaborative environment.
* Planning and organizational skills to prioritize and handle multiple tasks with a sense of appropriate urgency.
* Attention to detail necessary to maintain the required documentation.
* Developing technical prowess in self and others.
* Highly motivated self-starter; be proactive and creative in solving technical problems.
* Proficiency in Microsoft Office suite (e.g. Word, Excel, PowerPoint, Outlook, OneNote).
* Must be willing to travel.



Qualifications and Experience



* 7+ years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations and a Bachelor's degree with a discipline in Toxicology, Chemistry, Biochemistry, Biomedical Engineering, Bioengineering, or similar science/engineering discipline, or equivalent combination.
* A complete understanding and wide application of principle, theories, and concepts in biocompatibility per ISO 10993.
* Must have prior experience independently developing and driving biocompatibility evaluation strategies with scheduled and defined dependencies between tasks and deliverables for inclusion with worldwide regulatory submissions.
* Must have prior experience in supporting worldwide market registration.
* Proven experience with project management skills.




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