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Analytical Services Manager

Reference:SCASJN-314373
Location: Dublin
Qualification:Degree
Experience:7-9 Years
Job Type:Permanent
Salary:Not Disclosed
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Analytical Services Manager
Our client, a biopharma start-up are scaling up their team and are currently recruiting for an Analytical Services Manager to join their team on a permanent basis.Reporting to the VP, Technical Development, this position is responsible for ensuring timely completion of analytical services across the end-to-end supply chain through clinical development, registration, NDA / MAA submission and approval. As Analytical Services Manager you will ensure all analytical testing activities are complete to support clinical manufacture, registration, process validation, and commercial product release and stability requirements. In addition, the analytical services manager will interface with colleagues in CMC and Quality and with expert consultants to ensure the analytical methods and specifications are adequate and robust to support clinical supply and commercialization. As Analytical Services Manager you will use you will execute a practical, lifecycle approach to analytical methods development and validation activities to bring legacy analytical methods to the current standards and regulatory expectations.


Responsibilities

  • Develop, establish, and maintain Analytical Services programs, policies, processes, procedures and controls for starting materials, intermediates, APIs, excipients, drug products and drug-device combination products across multiple contract organisations, ensuring they conform to established scientific standards and regulatory guidelines
  • Plan, execute and manage analytical method development, validation, and testing activities to ensure on-time supply of clinical, registration, and process validation batches. Actively participate and where appropriate, take the lead in specification setting and method/specification/testing investigation
  • Provide Analytical support to device development of inhalation, injectable and intra-nasal drug-device combination products. Provide technical guidance on elements such as primary container interface and compatibility, design verification, stability, biological evaluation, extractables, transport & shipping studies, and clinical & registration batch manufacture
  • Work with CMC and Device Development in ensuring a product control strategy is in place to support combination product manufacture and transfer to manufacturing site
  • Develop stability programs across the supply chain, maintaining the status of each lot/product portfolio’s stability data
  • Author analytical sections of clinical phase submissions and NDA / MAA. Author responses to observations made on regulatory submissions
  • Evaluate existing analytical methods and specifications - plan and execute strategies to bring them up to speed with the latest advancements in the field and with current compliance/regulatory expectations.
  • Actively keep abreast of all changes and proposed changes in the pharmacopeia (e.g. USP, EP) and other regulatory guidance (FDA, EMA, ICH etc.) which might impact analytical testing activities. This includes starting materials, API, excipients, drug products and drug-device combination products.
  • Subject matter expert for all analytical activities across the supply chain (includes reference standard programs, all analytical method development and validation, release testing, stability testing, and analytical tech transfer).
Requirements
  • M.Sc. or Ph.D. in Chemistry, Pharmaceutical Sciences, or equivalent
  • Minimum of 7 years in analytical development, pharmaceutical development, or quality control laboratories
  • Must have prior experience in analytical methods development and validation, ideally across the supply chain from API starting materials through to drug product. Combination product experience, particularly Injectable and Inhalation experience, highly beneficial
  • Self-motivated with the ability to work in a fast-paced unstructured environment. Attention to detail and team player
  • Extensive theoretical background and experience in analytical chemistry supporting all phases of drug development programs (methods development, validation and specifications)
  • Possesses a thorough understanding of ICH guidelines
  • Strong organizational, communication, and decision-making skills. Proven planning expertise
  • Ability to effectively interact with all levels of internal and external management, including CROs
  • Expert in quality impact assessments and conducting troubleshooting. Proven ability to conduct quality incident investigations (OOS, OOT, Deviations and Investigations)
  • Experienced in writing analytical development and validation reports
  • Ability to critically review and approve analytical data and test methods
  • Must have prior experience interacting with CROs and CMOs engaged in projects. A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.











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