Snr Manufacturing Operations Manager

  • Location

    Limerick, Republic of Ireland

  • Sector:

    Executive

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Justin Pankinas

  • Contact email:

    mpgjobs@manpower.ie

  • Job ref:

    BBBH2413_1592834566

  • Published:

    5 months ago

  • Expiry date:

    2020-07-22

Senior Manager role is a key member of the downstream operations management team that manages and directs all facets of downstream commercial and clinical scale production at the site.

Essential Duties and Responsibilities:

  • Manages downstream commercial & clinical scale manufacturing according to approved protocols, regulation, and schedule.
  • Provides technical input to resolve process problems and complex compliance issues.
  • Communicate with Supervisors/Managers regarding technical, compliance & production process related issues
  • Implements new production processes transferred by the MSAT/PMPD teams
  • Performs cGMP audits of production area.
  • Represents manufacturing during regulatory audits.
  • Ensures that safety standards are maintained. Supports departmental safety projects.
  • Performs personnel management functions including scheduling of holidays, personnel development, and performance evaluations.
  • Works closely with HR to ensure teams are managed adequately.
  • Works closely with staff to develop and manage individual and team goals and objectives.
  • Interfaces with other departments, such as Facilities, Engineering, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
  • Formulates and recommends manufacturing policies, schedules, procedures and programs.
  • Develop high level Schedules, detailed production plans, and material requirements.
  • Coordinate and helps manage validation activities involving Manufacturing equipment and processes.
  • Reviews, and/or approves Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
  • Leads and implements continuous improvement initiatives.

Experience And Required Skills :

  • Bachelor, Master, or Doctorate degree in any of the physical or biological sciences, or chemical engineering and 10 -12 years biopharmaceutical/biotech work in a GMP production facility with BA/BS, alternatively 8 to 10 years with MA/MS, or 4-7 with PhD. 8+ years people management experience required;
  • Strong knowledge of recombinant protein manufacturing techniques and methods, which include purification and formulation of recombinant proteins;
  • Excellent interpersonal, written, and oral communication skills;
  • Substantial knowledge of cGMP's and experience in engaging with regulatory authorities.
  • Self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and who thrives in a dynamic environment
  • Able to engender trust and respect quickly as a manager of people, with a priority for the development of staff