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Work Cell Specialist CMC

  • Job reference: 926592
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 15/07/2019

Hello all. I am currently seeking a Work Cell Specialist CMC for an initial 12-month contract with our client in the south of Dublin. Please contact me at Andreia.Terron@orioneng.com for more details

Work Cell Specialist CMC

Description: Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure success.

Primarily responsible for Work Cell Specialist CMC activities, which may include any/all of the following:

  • Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records
  • Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team
  • Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level

Basic Qualifications:

  • Candidate will be working with team in the US, so we ideally need some flexible
  • Bachelor's in Business Administration, Engineering or Science-related field
  • 5+ years of experience in protein, API, DS, DP or packaging manufacturing environment (Preference is Drug Product)
  • 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
  • 2+ years of project management experience leading multi-functional and/or multi-location team
  • 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
  • Candidates needs to have change control and deviation experience is a must
  • Demonstrated matrix management and influencing skills.
  • Manufacturing and cGMP knowledge / experience.
  • Demonstrated negotiation skills.
  • Operational Excellence proficiency and ability to drive continuous improvement.
  • Financial/budgeting knowledge and business acumen.
  • Proficient project management skills.
  • Problem-solving and critical thinking.
  • Understanding of contractual requirements.
  • Technical writing and multi-level communication skills.
  • Demonstrated ability to lead effectively in collaborative/team environment.
  • Demonstrated ability to take initiative, drive action, and work under minimum supervision

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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