Associate Principal Scientist (Analytical) Full-time

Analytical Sciences Technical Support Role

The role holder is responsible for providing expert technical support related to Analytical Sciences to commercial products manufactured internally at AZ sites and externally at contract facilities. This role will not have direct reports.

Specific Responsibilities include:

• Responsible expert for a commercial product or group of commercial products related to the Analytical subject matter area (including analytical sciences and analytical technologies).

• Responsible for analytical lifecycle activities to ensure testing methods, drug product specifications and drug product control strategies are and remain fit for purpose and aligned with technology advancements.

• Leads the review of analytical methods performance via appropriate dashboards to ensure product and methods robustness across the QC network.

• Supports the definition of analytical standards impacting commercial products specific to regulatory expectations and good business or quality standards (including pharmacopeial standards).

• Provides training in subject matter expertise areas.

• Develops and manage a prioritized portfolio of project activities, with appropriate demand and supply oversight.

• Maintains a technical support model with outstanding customer service for all AZ manufacturing sites and external manufacturing/testing partners.

• Leads and assess impact of complex technical improvements or change activities assuring product and methods performance and robustness, including extractables and leachable assessments, nitrosamines risk assessments and risk assessments of elemental and organic impurities.

• Develop solutions to a diverse range of problems requiring complex judgements based on highly developed levels of conceptual thought, strategic vision and analysis.

General Responsibilities include:

• Provision of analytical technical leadership to support product supply strategy projects (sourcing, asset transfers, capacity expansion, etc.) and business continuity plans through delivery of the drug product control strategy, and product quality risk management activities throughout the lifecycle.

• Responsible for the analytical technical support during the transfer of established products within sites and to external manufacturing partners including support for equivalency determination as applicable.

• Support complex technical improvements or change activities assuring product performance and analytical methods robustness, including extractables and leachable assessments, nitrosamines risk assessments and risk assessments of elemental and organic impurities.

• Management of product knowledge throughout the lifecycle.

• Maintain technical knowledge in area of subject matter expertise including up to date advances in new regulations and technologies to aid in the improvement of pharmaceutical processes and or analytical methods.

• Regulatory file authoring, review, license renewals and response to questions.

• Support for drug product PPQ programs in the support of transfer and change activities.

• Provision of technical problem-solving expertise to aid in the resolution of manufacturing/method/formulation issues & complaints impacting supply or manufacturability.

The role holder will:

• Create an effective partnership, manage expectations and resolve issues positively and in the best interest of AZ.

• Ensure that all work is carried out in compliance with AstraZeneca and external regulatory policies and standards.

• Continuously improve in competence, scientific excellence and innovation.

• Operate at the highest level of risk management.

• Be an excellent communicator with strong interpersonal skills in order to collaborate effectively with stakeholders.

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to the role. Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.

Education, Qualifications, Skills and Experience

Essential:

• Have a good understanding of the overall drug development and commercialization process from development, launch and through life cycle management

• Likely to be educated to BSc, MSc or PhD level in an appropriate discipline, at least 5-10 years of experience relevant to the pharmaceutical industry and have professional credibility within the business and industry.

• In-depth understanding of analytical sciences in the Pharmaceutical Industry, applied to raw materials, intermediates and drug products, including definition of control strategies and specification setting.

• Have a thorough understanding of principles, applications and management of SHE and cGMP.

• Business acumen and capability to understand business cases in subject matter areas.

Desirable:

• Experience in or exposure to multiple disciplines in CMC and related functions (eg Development, Manufacturing, Quality Control, Regulatory, Quality Assurance, Global Supply)

• Have in depth understanding of multiple disciplines, such as (besides analytical) formulation, packaging, automation, validation.