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Principal Scientist

Company: Bausch Health Companies Inc.
Location: Petaluma
Posted on: January 8, 2022

Job Description:

Career Opportunities: Principal Scientist (5481) Requisition ID -5481 -- -Posted -16/07/2021 -- -R&D Development Petaluma -- -R&D -- -US - Petaluma, CA -- - City (1) Bausch Health 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 Health 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 Description: The Principle Scientist is a technical expert in Analytical Sciences for stability data analysis and stability assessment of pharmaceutical active ingredients, excipients, and drug products supporting NDA and ANDA submissions. Designs stability studies for complex pharmaceutical drug products in accordance to local and global regulatory requirements, executes complex stability set ups and monitoring. Has a good grasp of statistical principals and ability to perform statistical analysis of data using statistical software such as Minitab for establishing expiration dates and stability data trends. Has a thorough understanding of ICH Guidelines for pharmaceutical development. Prepares stability reports and drafts CMC sections for regulatory submissions. Has a good understanding and experience in using laboratory related IT and software. Has good understanding of Analytical techniques, method validation and test method requirements to support and develop pharmaceutical products specification profiles in accordance to QbD guidelines. Has good communication skills, is well organized and adept in identifying key project steps and corresponding timelines/deliverables. Monitors the scientific progress and budget of assigned projects. Prepares protocols and technical reports. Ensures that laboratory work under the job candidate's direction is scientifically sound and meets project objectives. Experienced in GMP and GLP, working with regulatory agencies for successful NDA and ANDA submissions. Responsibilities:

  • Exhibits leadership in the coordination, planning, and scheduling of the stability group activities under the direction of Department Management
  • Provides data analysis, evaluation, and technical problem solving
  • Responsible for supervision of the life cycle events (validation, calibration, & maintenance) of the physical facilities and equipment to support the stability function
  • Supervises and trains support staff
  • Prepares stability sections of CMC regulatory submissions
  • Evaluates systems and proposes changes in systems and procedures to improve efficiency, maintain competitiveness and reduce expenses
  • Advises department management on critical functional issues and presents stability updates to project teams
  • Manages sub-contracted laboratory work along with external data review and approval Requirements:
    • Provides group leadership for the stability work group and support staff
    • Works with project leaders to develop and execute stability protocols and programs; provides oversight for stability study initiation and scheduling
    • Coordinates testing with internal and external laboratories
    • Works closely with laboratory management, project leaders, and QA regarding work schedules and assignments to ensure timeliness of deliverables; makes presentations to project teams for stability updates
    • Provides oversight for the routine monitoring, calibration, installation, and maintenance of stability facilities and equipment to meet CGMP requirements
    • Analyzes data, identifies trends, and prepares quality reports that support the drug development and commercialization process
    • Ensures quality and timely review of documentation generated in the stability group
    • Provides reports to accounting related to stability storage charges
    • Assists Department Management in functional audits, developing and maintaining departmental and project budgets and controlling costs
    • Provides information to Department Management in development of project and operating budgets
    • Advanced troubleshooting and method development skills
    • Technical project leadership abilities
    • Safety minded in performance of duties
    • Quality minded with ability to perform work with accuracy and in accordance with established procedures
    • Effectively communicates with Manager, team members, and Senior Management
    • Organized and able to perform duties in a timely manner
    • Analytical Educational Requirements: Bachelor's or Master's Degree in Chemistry or related scientific field with approximately fifteen plus years of experience in pharmaceutical analysis P Preferred: PhD Degree in chemistry or related scientific field with ten plus years of experience in pharmaceutical analysis This position may be available in the following location(s): US - Petaluma, CA

      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 Health's Job Offer Fraud Statement .

Keywords: Bausch Health Companies Inc., Petaluma , Principal Scientist, Other , Petaluma, California

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