Principal Toxicologist

Johnson & Johnson Innovative Medicine•Cincinnati, OH

2d•$117,000 - $201,250•Hybrid

About The Position

The Principal Toxicologist, Toxicology & Biocompatibility will serve as a Subject Matter Expert (SME) and a technical lead responsible for Energy, Endomechanical, Biosurgery, Wound Closure & Healing, breast implant Aesthetics & Reconstruction medical devices, and external development opportunities. The role will involve the assessment and evaluation of novel biosorbable materials and technology platforms to deliver innovative surgical technologies and solutions. The Principal Toxicologist efficiently executes the biological safety evaluation of medical device products as per internal procedures and global standards and regulations. This person is responsible for planning and execution of in vitro and in vivo biocompatibility evaluations and ensures that products meet the requirements of biological safety according to relevant standards and regulations.

Requirements

An advanced degree (MS or Ph.D.) in Toxicology or a related scientific discipline is required.
A minimum of 6 years in relevant industry in medical devices is required.
A minimum of 8-10 years of experience in toxicology and biocompatibility assessments and evaluation in a medical device, pharmaceutical, and/or consumer product company or similar combination of professional training and multi-year experience in the industry is required.
Experience in medical devices is strongly preferred.
Experience working in a regulated environment of medical device safety and supporting product submission and audit is required; support for worldwide market registration is preferred.
Experience in absorbable biomaterials for implantable medical devices, including experience in medical device material degradation and toxicokinetics, is required.
Knowledge of toxicology & biocompatibility assessment of medical devices, coordination, and interpretation of biocompatibility and chemistry studies per relevant guidelines and requirements is required
Familiarity with relevant industry standards, i.e., ISO 13485, ISO 10993, ISO 14971, and design control systems is required
Knowledge of laboratory animal care & use practices is strongly preferred
Understanding of manufacturing processes of medical devices is strongly preferred.
Ability to work collaboratively as a team member across various functions and disciplines in a challenging and changing environment is required.
Interacts appropriately with all internal and cross-functional partners and demonstrates effective use of conflict resolution skills.
Demonstrates technical leadership and mentorship.
Demonstrates behavior qualities including confidence, transparency, integrity, innovation, passion, patience, and tenacity.
Excellent written and verbal communication skills.
Proactive and self-directed performance in an unsupervised environment and tenacity to overcome major obstacles are required.
Able to drive problem resolution efficiently and proactively through effective use of analytical and problem-solving skills.
May participate in organization programs/initiatives outside direct area of responsibility

Nice To Haves

Experience in medical devices is strongly preferred.
Knowledge of laboratory animal care & use practices is strongly preferred
Understanding of manufacturing processes of medical devices is strongly preferred.
Depending on location, local language skills are preferrable.

Responsibilities

Evaluates medical device products and materials for biological safety per international medical device regulations and standards, GLP (US FDA Good Laboratory Practice) guidelines, and internal procedures.
Designs, initiates, coordinates, and interprets laboratory investigations for biocompatibility and toxicology studies for medical device materials and products.
Applies technical expertise to solve biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety.
Liaises with internal and cross-functional team members to review existing product documentation and coordinates, together with more senior staff, biocompatibility test strategies to ensure appropriate planning and execution of required testing and completion of relevant deliverables.
Reviews, interprets, and summarizes testing data and ensures appropriate documentation and coordination of central documentation procedures required for risk assessment report completion.
Interacts closely with and provides technical guidance and expertise to internal stakeholders (e.g., R&D, Preclinical, Clinical Affairs, Regulatory Affairs, Medical Safety, Manufacturing, Quality Engineering, and Supplier Management) and external partners on medical devices across the entire product lifecycle.
Supports regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets.
Maintains effective communication of business-related issues or opportunities to next management level and if necessary, SMEs, via proper communication methods and/or tools.
Identifies and evaluates potential risks and drives resolution with team members, peers, and management.
Participates in continuous improvement activities and actively participates in shaping processes and procedures.
Responsible for communicating business-related issues or opportunities to next management level.
Responsible for following all company guidelines related to health, safety, and environmental practices as applicable.
Supports regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets.
Directly interacts with notified body (TUV, BSI) and regulatory representatives
Performs other duties assigned as needed.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year