Bausch & Lomb Incorporated

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Senior Scientist, Technical Operations

at Bausch & Lomb Incorporated

Posted: 9/15/2019
Job Reference #: 11548
Keywords: research

Job Description

  • Job LocationUS-NC-Raleigh
    Job ID
    Pos. Category
    Pos. Type
    Full Time
  • Overview

    Technical Operations is the organization within Global Manufacturing & Supply (‘GMS’) responsible for ensuring that externally sourced pharmaceutical products are scientifically robust, manufactured under control and remain in a constant state of validation throughout their product lifecycle in order to maintain a consistent supply of safe and effective products to patients.


    The Senior Scientist/Engineer of Manufacturing Science and Technology provides proactive support to enable 5 TECHNICAL OPERATIONS pillars. Responsibilities include:

    • Provides technical support to R&D support during manufacturing scale-up, process/packaging validation and launch of new products at external manufacturing organizations (EMOs).
    • Provides technical research and process knowledge in the implementation of change controls and technical transfers.
    • Monitors process yields, reliability, robustness and associated stability/shelf-life for trends and triggers for improvement via change control.
    • In collaboration with Quality, supports the accurate execution of routine process change controls, process validations and the analysis of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).
    • Supports a continuous process verification program for assigned projects via the collection and trend analysis of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) at EMOs
    • Collecting and analyzing key performance indicators (KPIs) to enable meaningful CPP/CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues.
    • Providing scientific leadership of technology transfers to/from external manufacturing sites to ensure right first time transfers.
    • Authors technical transfer protocols and reports to support regulatory filings (technical transfers, scale-up and post-approval changes.
    • Contributes scientific guidance during process/product deviations, out-of-trend/ out-of-specification (OOT/OOS) investigations and product complaints.
    • Use scientific and statistical analyses (of KPIs) to develop process understanding. Uses knowledge further in root cause analysis investigations.
    • Provides written technical justifications for regulatory proposals or regulatory submissions related to externally manufactured products.


    The following attributes are necessary:

    • Bachelor’s degree in in Chemistry, Chemical Engineering, or Pharmaceutical Chemistry with minimum 5 years of experience or Master’s Degree with 3 years of experience or Ph.D. with 2 years of experience in Pharmaceutical Technical Services encompassing Technical Transfer, Technical Trouble Shooting and Process Optimization.
    • CMC Subject Matter Expertize across a broad range of pharmaceutical dosage forms
    • Demonstrated industry experience supporting approved commercial products.
    • Direct experience with transferring technology and products from R&D to manufacturing.
    • Strong trouble shooting skills
    • Must be action oriented, make informed decisions and be self-motivated
    • Working knowledge of databases. Ability to utilize minitab or other statistical analysis software as needed.
    • Understanding of CMC regulatory requirements and technical risk management.
    • Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
    • Ability to detect and resolve problems, own decisions, and accomplish tasks/goals.
    • Ability to quickly change priorities and deliver targeted support.
    • Ability to present complex scientific information to a business audience.
    • Excellent verbal and written communication skills, detail oriented, and ability to work productively in an interdisciplinary team environment.