Principal Scientist

Date: Aug 6, 2022

Location: US-NY-Rochester, New York, US

Company: Bausch & Lomb

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 employees  and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. 

 

Position summary:

The Principal Scientist - Non Clinical Safety provides expertise and support to internal and external stakeholders pertaining to nonclinical toxicology, pharmacology and pharmacokinetics. Also provides critical assistance in strategy development and manages nonclinical studies in support of drug development programs.   The position will also support Surgical and Vision Care projects related primarily to product life cycle management activities and, to a lesser extent, product development activities.

 

Key responsibilities:

  • Develop and execute nonclinical safety assessment strategies for early and late-stage ophthalmic pharmaceutical development programs.
  • Develop and execute nonclinical safety assessment strategies for medical device product development and life cycle management (i.e., post-market) projects.
  • Ensures that development and execution of nonclinical strategies are aligned with product development and life cycle management activities, and with key regulatory milestones.
  • Manage biocompatibility/toxicology, pharmacology and DMPK studies at CROs. Present study results to project teams and prepare technical documents as needed.
  • Identify and work with external consultants to address specific scientific issues
  • Authors safety assessment of active ingredients, impurities, excipients and extractable/leachables for development and commercial support.
  • Contribute to preparation of nonclinical sections of regulatory documents including IND, CTA, IB, NDA, NDS, PMA, 510(k) and briefing documents.
  • Authors safety assessment documents to support global medical device submissions.
  • Able to travel for CRO study monitoring and professional conferences
  • Authors technical documents and mentors junior staff members

 

Qualifications and experience:

  • PhD in Toxicology, Pharmacology, or related discipline with a minimum of 2 years of relevant industry experience. MS in Toxicology, Pharmacology, or related discipline with at least 5 years relevant industry experience. DABT preferred

 

  • Strong experience in conducting safety assessments and authoring scientifically robust documents for drugs, impurities, ingredients/excipients, extractables/leachables
  • Experience in researching literature and toxicology database resources, and summarizing information.
  • Knowledgeable in regulations and guidances pertaining to drug development and safety evaluations (FDA, ICH) and compendia (e.g., USP, JP,EP). Experience with global regulations (e.g., US FDA, EU, Japan MHLW) and standards (e.g., ISO 10993 series) related to medical devices a plus.
  • Computer Literacy with skills in EndNote, Adobe Acrobat, Prism, Microsoft Excel, Word, Project and PowerPoint. 
  • Must be able to develop working relationships with various internal core competencies, manage outside suppliers, influence others outside of their immediate control and lead team members.
  • Strong interpersonal, teamwork, organizational and workload planning skills, as well as excellent written and verbal communication skills are required.

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This position may be available in the following location(s): US - Rochester, NY (GEHC)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement.

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