Analytical Development Associate Director

Analytical Development Associate Director

Teva

Larne, United Kingdom

Job Description

We are currently recruiting an Analytical Development Associate Director to join our team in Larne. The post holder will be responsible for direct reports located in TEVA NI Limited, Larne. The post holder will liaise with colleagues in R&D, Manufacturing, Product Supply, Regulatory Affairs, Marketing, Quality Assurance and external contractors in order to facilitate analytical activities associated with the development of new products. The post holder will oversee the day-to-day activities of the Analytical Development Department.

Main Duties and Responsibilities:

Leads the development of analytical CMC activities for the drug product development. Leads, plans, organises and directs the duties assigned to the Analytical Development Department by allocating appropriate resource and ensuring that all tasks are carried out in a timely and accurate manner and in accordance with written procedures. Oversees departmental budget.

  • Has a high level of expertise in a wide range of pharmaceutical dosage forms (e.g. tablets, capsules, soft gel capsules, semi-solids).
  • Leads analytical development and reviews and approves all associated protocols and documentation in accordance with the appropriate regulatory and quality guidelines.
  • Directs plans for experiments/protocols to ensure products are formulated in accordance with development SOPs to ensure robust methods for commercialisation.
  • Develops the processes and systems necessary for the compliance and continuous improvement.
  • To be knowledgeable of GMP, lean 6 sigma and all relevant procedures and guidelines applicable to pharmaceutical/analytical development.
  • To represent analytical at inter-departmental and/or cross-site meetings.
  • Has a high level of expertise in analytical techniques including HPLC and GC.
  • Has a general knowledge thermal analysis, DSC, MS, NMR etc.
  • Knowledge of analytical tech transfers.
  • To be responsible for the training of new personnel and for the professional development of reports.
  • Undertake any other duties, which may be assigned by Senior Management.

Key Skills

Key Skills Required:

  • Experience in working in a pharmaceutical GMP laboratory environment
  • Experimental design and interpretation of Data
  • Experience with Microsoft, Excel, power-point etc.
  • Analytical experience of multiple dosage forms
  • Knowledge of relevant regulatory guidelines and standards (e.g. 21 CFR 211)
  • Ability to author and review scientific reports and documents based on strong scientific rationale
  • Knowledgeable of FDA and/or EU regulatory submissions
  • Experience managing multiple projects simultaneously

Desirable:

  • Experience working within a cGMP environment
  • Knowledge of relevant regulatory guidelines and standards (e.g. 21 CFR 211)
  • Experience in development of drug delivery devices
  • Knowledge of statistics and software packages
  • Demonstrable problem solving skills.
  • Knowledgeable with FDA and regulatory submissions

Essential:

  • Experience in working in a pharmaceutical GMP laboratory environment
  • Experimental design and interpretation of Data
  • Experience with Microsoft, Excel, power-point etc.
  • Analytical experience of multiple dosage forms
  • Knowledge of relevant regulatory guidelines and standards (e.g. 21 CFR 211)
  • Ability to author and review scientific reports and documents based on strong scientific rationale
  • Knowledgeable of FDA and/or EU regulatory submissions
  • Experience managing multiple projects simultaneously

Qualification

  • BSc degree in Chemical or Biochemistry, Pharmacy or suitable equivalent

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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