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Drug Substance Leader

Company:
Berkley Recruitment Group
Location:
Louth, Country: Ireland
Job Type:
permanent
Job Description

Drug Substance Leader - Vaccines

Our global client is currently looking for a Drug Substance Leader for their vaccine's facility.
This position is at Director level

The Job:

Responsibilities:

  • Involve in the manufacturing process design, construction of facility, co-leading C&Q, support on PQ, site operation, PEV, calibration activities.
  • Supervise daily manufacturing activities under GMP compliance and ensure production timelines are met.
  • Collaborate with Process Development (PD), Manufacturing science and Technology (MSAT), and Project Management (FM) etc. for technology transfer, validation and related work.
  • Provide expertise and technical leadership in biopharmaceutical process technologies.
  • Communicate status of process, personnel, safety, environment, maintenance and other issues, in a timely manner to management team.
  • Coordinate Quality Assurance (QA)& Quality Control (QC)groups to ensure GMP compliance, manage deviation investigation and Corrective and Preventive Actions (CAPA)implementation, and support client auditing and agency inspections.
  • Lead continued improvement of manufacturing operation to increase efficiency and optimize the documentation (SOPs, MBR'. OJI's) to ensure they are current accurate, and clear.
  • Motivate, retain and develop existing group members and recruit, new staff to build a strong team, ensure training of all staff members up to date and can perform manufacturing operations safely and in compliance.
  • Author and review GMP documents including, but not limited to SOP/MBR/URS/FAT/SAT, as Well as review the executed batch record.
  • Ensure staff to complete trainings on time and up to date, and qualified to perform the operations per cGMP compliance.
  • Provide strong support for LSS activities within the team and facility.


Have you?

  • Master degree or above with major in Biology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major or person with equivalent experience
  • In depth Knowledge in Good Manufacturing Practice (GMP)production in cell expansion, cell culture, protein purification,
  • Production planning, quality assurance and control or related fields.
  • At least 10 years' experiences in Vaccine, Biotech or pharmaceutical industry.
  • Demonstrated excellent management skills and leadership.
  • Global perspective, Strategic thinking, Strong leadership.
  • Excellent written and oral presentation skill,
  • Detail-oriented organizational skill,
  • Have good communication and cooperation ability and can cooperate many departments to complete deviation investigation.
  • Oversea experience or trainings.


This is an excellent opportunity to join an established company as it expands its Irish operations. This is a permanent full-time opportunity and comes with excellent salary and full benefits package.

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aidan Crowley at 021 4289605 or send your CV to acrowley@berkley-group.com

Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: Berkley Recruitment Group
Company size: 1-49
Contact: NA