Principal Scientist-Toxicology

Date: Sep 22, 2022

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

Company: Bausch & Lomb

Bausch+Lomb Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health.  Each day, Bausch+Lomb products are used by over 150 million people around the world.

 

Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries. 

 

JOB TITLE

 

Principal Scientist / Sr. Research Scientist, Toxicology

BUSINESS TITLE

Principal Scientist / Sr. Research Scientist, Toxicology

BAND

MMT

BUSINESS UNIT / FUNCTION

Nonclinical, Department 7454

JOB CODE

 

LOCATION

Rochester NY (preferred), Bridgewater NJ, St Louis MO, Clearwater FL, Remote

OBJECTIVES/
PURPOSE OF JOB

This Research Scientist position within Nonclinical Safety will support the research and development of new ophthalmic products as well as maintenance of business activities for B+L Surgical Business Unit through the design of programs and/or safety strategies, execution of toxicology studies designed to meet regulatory guidelines, particularly ISO 10993, and author biocompatibility safety assessments and other regulatory documents.

KEY ACTIVITIES/
RESPONSIBILITIES

The person in this position will serve as core a team member, representing the Nonclinical Safety function.  Additional responsibilities include providing guidance and risk assessments (products, formulations/ingredients/materials, impurities, leachables and extractables), authoring regulatory documents, and assist in activities related to the management of relevant standards and regulations.

 

Specific Job Duties:

  • Design strategies, plan, and manage nonclinical safety/biocompatibility programs
  • Represent the Nonclinical Safety function on project teams
  • Conduct risk assessments on products, ingredients/materials, impurities and formulations, and author safety assessment documents per the requirements of ISO 10993-1, European Union (EU) Medical Device Regulation 2017/745 and other applicable standards
  • Oversee and evaluate activities of contract research organizations
  • Prepare necessary documentation (e.g. Central File Reports. Biological Safety Assessment Reports) to support regulatory submissions
  • Act as a Subject Matter Expert (SME) for ISO and other standards related to the nonclinical group.
  • Conduct gap assessments of ISO standards comparing newly released to recently withdrawn sections.  
  • Conduct gap assessments of products evaluating the reports and documents establishing the biocompatibility of the device with the current regulatory requirements.
  • Assist with routine departmental document archiving activities and those needed to support regulatory submissions
  • Able to travel for CRO study monitoring and professional conferences

SUPERVISE DIRECT REPORTS

(yes or no)

No

SCOPE OF POSITION – e.g.

  • Sales volume responsibility
  • Budget responsibility
  • Size of Team
  • Sites
  1. INFORMATION FOR THE POSITION)

This position is primarily focused on the development of new products as well as supporting maintenance of business including EU MDR compliance for surgical products/equipment.

KEY RELATIONSHIPS

(e.g. internal customers/business partners, external customers/partners)

The position interacts directly with B+L functional groups (e.g., Regulatory, Analytical Chemistry, and Quality) and other R&D groups in Rochester, St. Louis, Irvine and Clearwater. 

QUALIFICATIONS/
TRAINING

(e.g. professional qualifications, on-the-job training, education)

The position requires a degree (Bachelors, Master or PhD) in a related field, including toxicology or other biological sciences.

EXPERIENCE

(e.g. health care industry, multinational company, number of years, what level/types of roles, etc)

 

The position requires a minimum of 3 year (PhD) or 7 years (MS, BS) in regulatory toxicology for medical devices; experience with ophthalmic surgical products/equipment highly preferred. 

  • Working knowledge in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
  • Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).
  • Experience in managing nonclinical safety studies at external facilities
  • Experience working in Design Control (e.g. PDP) environment
  • Strong computer and general software skills; familiarity with Documentum preferred
  • Strong oral/written communication skills 

 

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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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