Job Description

Operations Lead will serve as primary production
process owner responsible for New Product Introduction, Life Cycle Management
Projects and/or CAPEX projects and established process improvements projects.
This role requires in-depth technical and operational knowledge of aseptic Drug
Product manufacturing processes; Parts/Components Preparation, Formulation,
Syringe Filling, Vial Filling, Lyophilisation and Capping.

They will be the operations point of contact for
coordination of the manufacturing effort and will be responsible for driving
process efficiencies as part of the project for operations.
They will apply process, operational, scientific
expertise, basic compliance knowledge, and analytical and troubleshooting
skills to ensure streamlined manufacturing operations are enabled in both vial
and syringe facilities.
Job is site based 4 days per week

Primary
responsibilities:

  • Function as
    the site interface between the Product Delivery Teams (PDT’s), and ADL
    Manufacturing operations.     Engaging
    with staff members within the Manufacturing department to ensure understanding
    of the processes and working collaboratively cross functionally with Facilities
    & Engineering, Quality, PD and Supply Chain.
  • Develop,
    review, and approve Generic Master Batch Records and Parameter Value Lists
    across Formulation, Filling and Inspection
  • Develop,
    review and update Production, Engineering, Operating Procedures & training
    materials    .
  • Assist in
    providing training on scientific or technical aspects of the current
    process/project(s) to Direct Manufacturing    .
  • Evaluate,
    plan, and implement solutions for process improvement opportunities both
    current and project related.
  • Support
    scheduling and execution of Characterisation, Engineering and PPQ runs,
    ensuring all necessary pre-requisites are included on the schedule and assess
    process performance by observation of floor operations and review of
    performance data    .
  • Provide
    troubleshooting support throughout the project and on the floor during
    execution of activities    .
  • Hold people
    to account for delivery and behaviors within the Manufacturing Support team and
    associated with the project(s)    .
  • Perform Job
    Hazard Assessments and Change Control Assessments to determine impact to
    Manufacturing    .
  • Partner with
    Learning & Performance to define training strategies for current processes,
    NPIs and complex projects    .
  • Consult with
    Quality Assurance to ensure that GMP standards are maintained in line with
    current SOP’s, batch documentation and licences    .
  • Develop,
    review and update Protocols for manufacturing activities


Requirements

  • Bachelor’s
    degree in a science discipline.
  • 3+ years of biopharmaceutical
    manufacturing experience in Fill Finish or related manufacturing or GMP
    experience in the pharmaceutical or medical device industry.
  • Experience with regulatory compliance in cGMP manufacturing and testing
    of pharmaceutical products
  • Strong Project Management Skills
  • Critical thinking skills: Gathers data from key
    stakeholders, analyses and interprets information to develop solutions to
    technical problems of moderate complexity    ​