Lead Biocompatibility Engineer / Lead Toxicologist

Lawrence Harvey


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.


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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