Principal Scientist – Pharmaceutical Sciences

The role holder is responsible for providing expert technical support to commercial products manufactured internally at AZ sites and externally at contract facilities. 

General Responsibilities include:

• Maintaining skills in assigned core capabilities for example, but not limited to, documentation practices, quality and regulatory compliance, data integrity, change management, GPM, lean capabilities & product security.
• Management of product knowledge throughout the lifecycle.
• Maintain technical knowledge in area of subject matter expertise including up to date advances in new technologies to aid in the improvement of pharmaceutical processes and or methods.
• Regulatory file authoring, review, license renewals and response to questions.
• Provision of 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, manufacturability strategy and product quality risk management activities throughout the lifecycle.
• Responsible for the 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 including extractables and leachable assessments, nitrosamines risk assessments and risk assessments of elemental and organic impurities.
• 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.
• Assist in the development of CAPAs to eliminate root cause(s).

Specific Responsibilities include:

• Responsible expert for a commercial product or group of commercial products related to the Pharmaceutics subject matter area.
• Responsible for lifecycle activities to ensure equivalence across sites e.g., specifications, methods, processes.
• Leads Global review of product performance via appropriate dashboards/CPV assessments to ensure product and process robustness.
• Support for defining technical standards impacting commercial products specific to regulatory expectations and good business or quality standards (including pharmacopeial standards).
• Provision of training in subject matter expertise areas.
• May be the product lead for one or more products coordinating TOSI activities and being the point of contact for general matters for these products as well as representing TOSI in the Global Supply Teams (GST) and/or Pharmaceutical Teams (PT).
• Executing Technical leadership and influencing in Pharmaceutical Teams and within TOSI.
• Develop and manage a prioritized portfolio of TOSI project activities, with appropriate demand and supply oversight.
• Ensure ( in collaboration with TOSI SPOC) effective collaboration between PT&D and the AZ sites/External Supply Management (ESM) managed sites and Global Partners.
• Maintain a technical support model with outstanding customer service for all AZ manufacturing sites and external manufacturing/testing partners.
• Build effective networks across the Global Operations organisation.
• Lead and assess impact of complex technical improvements or change activities assuring product performance 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.
• Technical leadership to Issue Management Team (IMT).
• Project resource estimations to support the budgeting process.
• Responsible for the assessment of impact and management of the decision making process across functions for issues spanning across sites and functions outside of PT&D.
• Coaching of technical experts across PT&D in subject matter areas.
• Identify cross product or brand challenges or opportunities for commercial drug products.
• Leadership of technical strategic initiatives, networks or forums within the organization.
• Recognized externally as a technical leader with a track record of consistent delivery.
• Executing Technical Leadership and influencing across Operations and PT&D.
• Providing Technical Expertise to external partners and in external networks

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 Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

All these activities will have a significant impact on the overall success of Operations as well as ensuring the commercial viability of current products. The activities of the TOSI organization help to ensure availability of all AstraZeneca products to the commercial organization. The role, therefore, has a significant impact on both financial and reputational aspects of the business.

Education, Qualifications, Skills and Experience

Essential

• 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, MSc or PhD level in an appropriate discipline 10+ years of experience relevant to the pharmaceutical industry experience and have professional credibility within the business and industry.
• Good communication skills in both Mandarin & English.

Desirable

• Experience in or exposure to multiple disciplines in CMC and related functions (eg Development, Manufacturing, Global Supply, Marketing Companies)
• Have in depth understanding of their multiple disciplines, such as, analytical, formulation, process engineering, modelling or validation.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.