Research Scientist-Toxicology

JOB TITLE

Research Scientist / Sr. Research Scientist, Toxicology

BUSINESS TITLE

Research Scientist / Sr. Research Scientist, Toxicology

BAND

MMT

BUSINESS UNIT / FUNCTION

Nonclinical, Department 7454

JOB CODE

LOCATION

Rochester NY

OBJECTIVES/
PURPOSE OF JOB

This Research Scientist/Sr. 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 and Vision Care Business Units 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

This 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..  Other responsibilities may include work supporting pharmaceutical products.

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• Conduct gap assessments of ISO standards comparing newly released to recently withdrawn sections.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

7. INFORMATION FOR THE POSITION)

This position is primarily focused on the development of new products as well as supporting maintenance of business for surgical and vision care products/equipment.

KEY RELATIONSHIPS

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

The position interacts directly with B+L functional groups including R&D groups in Rochester, Waterford, St. Louis and Clearwater.  Also Regulatory, Analytical Chemistry, and Quality groups in the various business units.

QUALIFICATIONS/
TRAINING

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

The position requires a Master or PhD degree 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 1 year (PhD) or 5 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