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Snr/Technical Manager – Microbiology – Location: Various


Job Title: Snr/Technical Manager – Microbiology

Locations: West Chester, Ohio, United States | Macclesfield, England, United Kingdom | Södertälje, Stockholm, Sweden

Job ID: R-062469

The only way to apply for this role is by following the link below.

Career Level:E or F dependant on Skills and experience.

This role resides in the On-market technical function within the PT&D (Pharmaceutical Technology & Development) Organization in the Operations SET area. The PT&D Organization is responsible for drug product design, development and technical support for drug substance and products throughout the life cycle. The On Market Technical Functions provide the experienced technical support for AstraZeneca commercial products. It is a multi-skilled organisation who provide technical support and expertise related to drug product formulation, manufacture, process engineering, statistics, modelling, devices and testing. The key activities where we deploy our technical expertise are in the support of drug product improvement projects, changes, technology transfers, investigations, regulatory responses, new submissions, product robustness, validation, risk and manufacturability.

Under pinning the excellent technical support that drives robust product supply are technical processes & strategies around knowledge management, manufacturability, technical validation approaches, problem solving in alignment with the delivery of the technical inputs needed for fulfilling the Global Product Supply Strategy. The On Market technical functions are a strong network of scientists located across the world at our key manufacturing, development sites and strategic hubs. We work closely with many technical functions across Operations providing the ability to drive science and build capability within our organisation and our ways of working.

Candidate Focus and Challenge

The role of the Snr/Technical Manager – Microbiology has the following responsibilities:

  • Responsible expert in pharmaceutical unit processes related to providing support process- design and aseptic control.
  • Provision of technical expertise & leadership to aid in the resolution of potential microbiology related manufacturing issues & complaints impacting supply
  • Responsible for the assessment of impact and management of the decision-making process across functions for major issues spanning across sites and functions outside of PT&D.
  • Provision of technical support and decision-making in the event of product recall incidents
  • Development of suitable corrective and preventive actions in support of investigations.
  • Provision of technical expertise to support product supply strategy projects (sourcing, asset transfers, capacity expansion, new equipment etc) and business continuity plans through delivery of the drug product control, manufacturability strategy and product quality risk management activities throughout the lifecycle.
  • Develop, lead & support a prioritized portfolio of project activities, with appropriate demand and supply oversight.
  • Responsible for the microbiology technical support during the transfer of established product manufacturing processes within sites and to external manufacturing partners. Including scale up modelling support.
  • Take leadership in developing, maintaining and collaborating with contract manufacturers in the support of changes and issues.
  • Lead, assess impact & support complex technical improvements or change activities assuring product performance.
  • Management of product knowledge throughout the lifecycle.
  • Drive standardisation & modernisation of microbiology and aseptic design across Operations.
  • Develop and maintain understanding of both microbiology and academic landscape in relation to manufacturing sciences.
  • Find opportunities for manufacturing improvements with respect to microbiological control.
  • Maintain technical knowledge in new microbiology and aseptic technologies including up to date advances in new technologies to aid in the improvement of pharmaceutical processes.
  • Provide support for regulatory file authoring, review, license renewals and response to questions.
  • Support for defining technical standards impacting commercial products specific to regulatory expectations and good business or quality standards.
  • Provision of training in subject matter expertise areas.
  • Mentoring of technical experts across PT&D in Manufacturing Science subject matter areas.
  • Identify cross product or brand challenges or opportunities for commercial drug products related to microbiology technology needs.
  • Leadership of technical strategic initiatives, networks or forums within the organisation.
  • Recognised externally as a technical leader in the Microbiology field.
  • Lead or influence Science and Technology strategy for new technologies.

Candidate Knowledge, Skills and Experience

To qualify for the position, the applicant should have the following skills:

Role Requirements:

  • Have an excellent understanding of the overall drug development and commercialization process from development, launch and through life cycle management.
  • Likely to be educated to BSc with ~7-10+ years of relevant pharmaceutical industry experience) post degree or PhD level with 7+ years of experience post degree in Microbiology or similar discipline etc and have professional credibility within the business and industry.
  • Be an expert in pharmaceutical microbiology and aseptic processes.
  • Have an understanding of a broad range of microbiology methods and testing technologies.
  • Have experience of a broad range of CMC elements related to commercial product requirements – e.g. development pharmaceutics, process establishment and optimisation, control of drug products, biopharmaceutics, stability, packaging and commercial manufacturing & validation.
  • Previous experience of microbiology method selection, operating principles and validation.
  • Have a detailed understanding of principles, applications and management of SHE and cGMP.
  • Experience in Operations and/or R&D with a track record of successful project leadership and delivery within a matrix organization.
  • Evidence of excellent interpersonal skills and build excellent relationships with customers.

Preferred Requirements:

  • Experience in or exposure to multiple disciplines in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
  • Have previous experience regulatory cGMP requirements for aseptic manufacture.
  • Have strong leadership skills and behaviours with demonstration of being able to work across different functions.

To Apply:

The only way to apply for this role is by following the link below.