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- Tasks: Lead analytical support for major commercial products and drive technical improvements.
- Company: Join a dynamic team focused on innovation in drug product development and manufacturing.
- Benefits: Enjoy opportunities for professional growth, collaboration, and impactful work in the life sciences field.
- Why this job: Be at the forefront of science, making a difference in drug product quality and compliance.
- Qualifications: Bachelor's degree with 8 years in life sciences; strong analytical and regulatory experience required.
- Other info: Ideal for those passionate about problem-solving and cross-functional collaboration.
The predicted salary is between 36000 - 60000 £ per year.
Insight Global are looking for an experienced Associate Principal Scientist – Analytical to play a key role in our client’s Technical Operations Science and Innovation (TOSI) organization. TOSI provides technical support and expertise related to products, manufacturing, analytical, process engineering, statistics, modelling, devices, and testing.
The areas in which they deploy their 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. This role works closely with many technical functions across Global Operations providing the ability to drive science and build capability within the organization and the ways of working.
Responsibilities:
• Responsible expert for a major commercial product or group of products related to the Analytical subject matter area e.g. Oral Solid Dosage formulations, parenteral formulations,
• Leadership and support for regulatory file authoring, review, license renewals and response to questions, including coaching colleagues with these activities.
• Provision of strong technical expertise & leadership to aid in the resolution of analytical method issues & complaints impacting supply.
• Development of suitable corrective and preventive actions in support of investigations.
• Responsible for the technical support during the transfer of established product analytical methods within sites and to external manufacturing partners including support for equivalency determination as applicable.
• Lead, assess impact & support complex technical improvements or change activities assuring product and methods performance.
• Responsible for analytical method lifecycle activities to ensure performance and compliance across sites.
• Identify opportunities for analytical method improvements.
• Provision of training in subject matter expertise areas.
Must Haves:
• Bachelor\’s Degree with 8 years of professional working experience in a life sciences role with a focus on Data Analysis & Interpretation
• Significant experience of preparing regulatory submission and responses to regulatory questions
• Excellent understanding of OSD products life-cycle, from launch and through life cycle management until discontinuation.
• Understanding of commercial product requirements in the areas of analytical methods establishment and optimization, control of drug products, biopharmaceutics, stability, trace analysis (e.g. elemental impurities, extractables & leachables).
• Significant experience in analytical methods optimization and transfer, including understanding of equipment and method capability and performance.
• Significant experience on issue investigation and change assessment from an analytical point of view. Good knowledge of standard tools for root cause analysis (5 whys, PPS, Level 0, etc…)
• A thorough understanding of principles, applications and management of SHE and cGMP.
• Evidence of excellent communication skills and build excellent relationships with customers.
• Experience in or exposure to multiple disciplines in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
• Strong leadership skills and behaviours with demonstration of being able to work across different functions/ countries/ cultures.
• Previous experience and training in Lean, problem-solving tools and have experience in data analysis and interpretation.
Plusses:
• Master\’s Degree with 5 years of experience or PhD with 3 years of experience in a relevant industry such as pharmaceuticals
• Pharmacopeial experience; both general chapters and monographs (specific to the products they support)
Associate Principal Scientist - Analytical employer: AstraZeneca
Contact Detail:
AstraZeneca Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Principal Scientist - Analytical
✨Tip Number 1
Familiarize yourself with the specific analytical methods and technologies relevant to Oral Solid Dosage (OSD) formulations and parenteral formulations. Understanding these areas will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the life sciences field, especially those who have experience in regulatory submissions and analytical method optimization. Engaging with industry experts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and regulations in the pharmaceutical industry, particularly those related to analytical methods and compliance. This knowledge will be crucial during discussions with interviewers and can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss specific examples of how you've led technical improvements or resolved analytical method issues in your previous roles. Concrete examples will showcase your leadership skills and problem-solving abilities, which are essential for this position.
We think you need these skills to ace Associate Principal Scientist - Analytical
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in analytical methods, regulatory submissions, and leadership roles. Use specific examples that demonstrate your expertise in the life sciences field.
Craft a Strong Cover Letter: In your cover letter, express your passion for the role and the company. Highlight your significant experience in data analysis and interpretation, as well as your understanding of OSD products and lifecycle management.
Showcase Leadership Skills: Emphasize your leadership skills and experiences in your application. Provide examples of how you've successfully led projects or teams, particularly in technical operations or analytical method improvements.
Highlight Communication Abilities: Demonstrate your excellent communication skills by providing examples of how you've built relationships with customers or collaborated across different functions. This is crucial for the role's responsibilities.
How to prepare for a job interview at AstraZeneca
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with analytical methods, especially in relation to Oral Solid Dosage and parenteral formulations. Highlight specific projects where you provided technical support or resolved analytical method issues.
✨Demonstrate Regulatory Knowledge
Since the role involves regulatory file authoring and responses, be ready to share examples of your experience in preparing regulatory submissions. Discuss how you've handled regulatory questions and coached colleagues through these processes.
✨Highlight Leadership Skills
This position requires strong leadership abilities. Prepare to discuss instances where you've led cross-functional teams or initiatives, particularly in technical improvements or change activities. Emphasize your ability to build relationships across different functions and cultures.
✨Prepare for Problem-Solving Scenarios
Expect to encounter questions related to problem-solving and root cause analysis. Familiarize yourself with standard tools like the 5 Whys and be ready to discuss how you've applied these methods in past experiences to resolve analytical issues.
