Principal Toxicologist
Principal Toxicologist
Posted on :
24-06-2025
Employer Active
1 Vacancy
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Job Description
Job Description
As a Toxicologist your responsibilities will include but are not limited to the following:
- Prepare hazard identification and toxicology risk / safety assessments for impurities excipients leachables extractables etc.
- Conduct SAR and QSAR modelling of compounds
- Review interpret and position data (study reports literature safety data)
- Conduct technical dossier gap analysis and independent data reviews
- Validity review of performed studies
- Remain abreast of advances in the field
- Actively participate in US working groups for standards development (e.g. AAMI)
- Provide technical support and guidance on client calls
- Serve as a thought leader and mentor to junior members of the team
Essential Duties and Responsibilities:
- Applies GMP/GLP in all areas of responsibility as appropriate
- Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
- Make technical decisions without consulting management
- Guide and mentor junior staff to successfully complete projects and grow technical knowledge
- Do independent research into regulatory trends and technical advances
- Be a technical resource for internal problems throughout ELLI
- Provide support for corporate initiatives through BPT network
- Provide coverage for management when needed
- Document testing observations deviations and results clearly and completely and in compliance with regulatory requirements - striving to minimize errors
- Understand and perform calculations as required by test methods
- Understand and utilize computers for information access calculations and report preparation
- Read and understand analytical procedures (compendial and client supplied) and internal SOPs
- Provide consultation for clients
- Demonstrate technical writing skills and complete investigations independently
- Demonstrate leadership qualities including;
- Effective communication
- Display confidence
- Demonstrate motivation and take initiative
- Follow through on assignments
- Process/review data generate/review reports and evaluate data
- Communicate effectively both orally and in writing
- Suggest and implement lab improvements or modify existing processes to maximize quality and productivity; support and drive LEAN initiatives
- Support or identify speaking or publishing opportunities and assist with driving to publication or presentation
- Commitment to occasional overtime as workload requires
Qualifications :
Minimum Qualifications:
- Bachelors Degree in Toxicology or other related degree concentration or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- Authorization to work in the US without immediate OR future sponsorship
- Minimum of 10 years experience performing biological evaluations of medical devices per ISO10993 (i.e. authoring biological evaluation plans (BEPs) biological evaluation reports (BERs) and toxicological risk assessments (TRAs)
- Strong understanding of the full scope of ISO 10993 as well as other relevant industry and regulatory standards
- Good dexterity; positive attitude; solution driven; good work habits (organized efficient careful safety-conscious accurate); attention to detail; sound scientific logic; good oral and written communication skills; understanding of multiple instrumentation platforms and/or instrumental theory; client service focused; demonstration of organizational skills; ability to independently work on complex projects; ability to multitask; technical writing skills
Additional Preferences:
- Certification as a Diplomate of the American Board of Toxicology (DABT)
- Involvement and leadership in relevant international standards committees (e.g. ISO AAMI etc.)
- 10 years experience in performing biological evaluations of medical devices on the basis of ISO10993-17.
- Advanced degree in toxicology or related degree concentration
- Familiarity with a broad range of medical device applications
- Strong computer scientific and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team self-motivation adaptability and a positive attitude
- Ability to learn new techniques perform multiple tasks simultaneously keep accurate records follow instructions and comply with company policies
- Strong leadership initiative and teambuilding skills
Additional Information :
Working schedule will be Full-Time First Shift 8am-5pm M-F. Overtime may be required when necessary. Candidates currently living within a commutable distance of Lancaster PA are encouraged to apply.
What we Offer:
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
Key Skills
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