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Director, Engineering

Company: Bausch Health
Location: Petaluma
Posted on: January 7, 2022

Job Description:

Requisition ID -5982 -- -Posted -28/08/2021 -- -Quality -- -Quality -- -US - Bridgewater, NJ -- - City (2) 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. - Position summary: The Director -Bioprocess Engineering is responsible for supporting the overall manufacturing process by applying QbD principles and a broad array of scientific approaches to solve operational and investigational challenges incurred in the upstream/downstream production of bulk biologics, proteins and/or peptides. This position reports to -the VP of Technical Operations and - is expected to ensure that the growing portfolio of biologics 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 . Key responsibilities:

  • Provides technical 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.
  • 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)
  • Collects and analyzes key performance indicators (KPIs) to enable meaningful CPP/CQA trending and reporting of key process data and changing quality trends/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. Qualifications:
    • MS or Ph.D. degree in Peptide/ Bioorganic chemistry or related biological sciences or equivalent with a minimum of 6-10 years of experience in commercial biologic production or peptide/protein chemistry
    • 7 or more years experience with or biologic production processes under GMP compliance
    • 5 or more years experience in Pharmaceutical Technical Services encompassing Technical Transfer, Technical Trouble Shooting, Process Optimization or related technical function
    • Demonstrated CMC experience in Biologics
    • Demonstrated industry experience supporting approved commercial products.
    • Direct experience with transferring technology and products
    • Strong trouble shooting skills
    • Must be action oriented, make informed decisions and be self-motivated
    • Working knowledge of databases. Ability to utilize 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. Desired experience:
      • Experience in the application manufacturing equipment such as incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers, and in-process testing equipment desired.
      • Experience in the purification and characterization of antibodies or engineered proteins desired OR experience in commercial peptide synthesis, modifications and/or purification processes desired.
      • Experience with high-throughput purification platforms and bioanalytical characterization techniques is desired (HPLC/UPLC, DLS, DSF, iCIEF, ceSDS)
      • Experience with common protein and antibody purification techniques (e.g. Protein A, SEC, IEX, HIC etc...) and other high-performance chromatography systems. This position may be available in the following location(s): US - Bridgewater, NJ

        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, Petaluma , Director, Engineering, Executive , Petaluma, California

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