Principal Scientist - Toxicology

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

Alcon is looking to hire a Principal Scientist to join our R&D Team in Fort Worth, TX. You will be responsible for toxicological and biocompatibility evaluations of products and technologies required for product approvals and patient safety across the Alcon Technology Platforms.

Responsibilities:

• Partner with toxicology leaders to develop robust biocompatibility and nonclinical testing strategies to meet project goals and ensure patient safety of products.
• Conduct safety assessment for new product development and provide solutions for evaluation of safety risk for manufacturing and product life cycle assessments.
• Work functional leaders across the organization to execute product design evaluations required for product approvals
• Drive interactions with project teams early in the process to identify potential toxicological/safety risks to projects and develop robust Biological Evaluation Plans to mitigate the risks.
• Interface closely with the manufacturing site to ensure business needs are met for life cycle management and materials teams for product stewardship toxicology assessments.
• Competent in literature searches, extracting relevant information, critical study selection to aid in developing the risk assessment.
• Familiar or experience in conducting risk assessments according to ISO 10993-17.
• Experience with in-silico and QSAR models for use in toxicological risk assessments (e.g., Derek/Nexus, Tox Tree, OECD QSAR Tool Box, etc.).
• Familiar or experience with ISO 14971, ISO 13485, ISO 10993-1 standards.
• Experience developing and executing nonclinical toxicology studies under Title 21 CFR; Part 58 Good Laboratory Practice (GLP) Regulations.
• Familiar or experience with medical device submissions (e.g., PMA, IDE, MDR, etc.) to regulatory authorities.

Toxicology Research (Life Sciences) work includes:• Conducting and summarizing toxicology safety studies on new drug substances• Designing toxicology strategies and programs• Studying the effects of chemical substances on animals and conducting toxicology investigations on experimental drugs• Conducting postmortem toxicology investigations on experimental drugs in animals• Developing and improving methods for drug safety evaluation.• Analyzing and preparing reports of findings• Performing advisory functions in dealing with items found to contain toxic material• Completing and/or reviewing toxicology section of submissions to regulatory agencies

Preferred Requirements:

• Advanced Degree and five years of directly related experience

Key Requirements/Minimum Requirements

• Bachelor's Degree or equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
• The ability to fluently read, write, understand and communicate in English
• 5 Years of Relevant Experience
• Work hours: Standard M-F
• Travel Requirements: Minimal
• Relocation assistance: Yes
• Sponsorship available: No

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [email protected] and let us know the nature of your request and your contact information.