Toxicologist

Description:

The Research Scientist I of Preclinical (Toxicology and biocompatibility) will support a portfolio of drug, medical device, drug packaging system, and/or combination product development and global registration. This individual will apply expertise in toxicology, biocompatibility, and related scientific knowledge for supporting and executing non-clinical safety / efficacy, toxicology risk assessment and/or biocompatibility strategies to assure product (patient) safety and efficacy through the application of current pre-clinical science, non-clinical safety assessment, and toxicological principles and methods to enable and support new product development (NPD), sustaining product organization (SPO) and margin improvement projects (MIP) and associated product development lifecycle management (PDLM) processes and initiatives.

Duties and Responsibilities:

• Author complicated studies/ toxicology risk assessment reports and review or concur toxicology assessment reports as subject matter expert (SME) in accordance with ICH and ISO10993-17.

• Toxicological risk assessment of chemicals used/encountered in manufacturing

• Participate and contribute in core technical team meetings as SME and provide inputs and lead task to be executed for completion of projects.

• Maintain current knowledge of relevant regulatory requirements related to toxicology, product development, design and safety

• Perform as preclinical/toxicology representative on project teams. Design, plan, monitor various GLP toxicity studies, biocompatibility studies, risk/safety assessment (risk assessment and qualification of impurities, leachables, extractables, residual solvents and excipients) for regulatory submissions. Participate in change control management and impact assessment. Perform/support audits/inspection (GLP) of studies/sites/facilities (CROs).

• Prepare and/or review nonclinical eCTD and PBRER sections

• Utilize Lhasa Derek and Sarah Nexus software to assess toxicological endpoints.

• Execute tasks within budget at the project level to ensure the best utilization of financial resources.

Qualifications:

• Relevant knowledge of ISO 10993-1, ISO 10993-17 and ISO 10993-18 required.

• Experience authoring Toxicological Risk Assessments and deriving Tolerable Intake values, Margin of Safety and Analytical Evaluation Thresholds.

• Shown technical writing ability and oral presentation to enable clear communication of study results, safety evaluations, and toxicology assessment conclusions.

• Ability to work independently and prioritize assignments to meet project schedules.

• Can effectively collaborate in a global team, including ability to work with individuals of diverse scientific and cultural backgrounds across multiple business units as well as with external partners/CROs.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $45 - $50