Drug Substance Analytical Project Expert - Macclesfield, United Kingdom - AstraZeneca

AstraZeneca

Verified Company

Macclesfield, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Role Name:
Drug Substance Analytical Project Expert

Location:
Macclesfield, UK

Competitive Benefit & Salary

Closing Date: 26/ 03/ 2024

AstraZeneca is a global, innovation-driven biopharmaceutical company, where we not only focus on the discovery, development, and delivery of life-saving medicines to our patients but believe in sustainability and are determined to minimise the impact of our work on the environment.

We are proud to be a great place to work and have a culture that encourages innovation and teamwork.

We empower our colleagues to be their authentic selves, express diverse perspectives and at the same time feel valued, respected, and rewarded for their ideas and creativity.

Pharmaceutical Technology & Development:

Pharmaceutical Technology and Development (PT&D) are the bridge, which turns brilliant science into medicines that help millions of people.

We work across the entire value chain, crafting and delivering active pharmaceutical ingredients (API's), formulations and devices required to support new medicines - from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

Drug Substance Development:

In Chemical Development we believe that nothing is impossible, and we are determined to push the boundaries of science to deliver medicines to patients.

Focussed on late stage (Phase 2/3) and commercial drug substance, we combine technical knowledge and understanding with individual talent to define the commercial control strategy, drive design, development, and optimisation of synthetic routes and analytical methodologies that deliver medicines in a balanced, commercially viable way.

As a department delivering scientific excellence, we are focussed on innovation, continuous improvement, sustainability, automation, and lifelong learning.

The department and analytical area are growing, AstraZeneca are recruiting highly experienced project leaders to lead multiple or sophisticated projects in our small molecule, new modalities, and commercial drug substance teams, defining and ensuring the next generation of medicines.

Key responsibilities:

As an expert project lead, you will bring a depth of late phase experience to development and commercial control strategy understanding to navigate drug substance manufacture, clinical and commercial supply demands, whilst developing and implementing control strategies that are deliverable in the clinical and commercial environment
You will work independently leading interactions and stakeholder management across project management, quality and regulatory departments ensuring success in CMC project delivery. You are expected to drive continuous improvement by always seeking to optimise our current ways of working or through developing innovative approaches to project delivery
You will contribute to the department ambition of supporting and growing careers in science by leading successful initiatives that include driving forums for shared learning, as well as mentoring and developing scientists across analytical within chemical development

Specifically, this includes:

Leading complex large or small molecule projects, late phase (2b/3) to commercial within analytical skill area
Delivering control strategies throughout the development and post approval phases of projects.
React to changes in the regulatory environment, supporting and implementing changes within the business.
Provide scientific/technical and strategic leadership across the skill groups in resolving risks, whilst identifying learning to share across the department.
Deliver CMC content or contributions to regulatory filings throughout the clinical development phase and commercial filings, managing updates, change control and post approval changes.
Coaching and developing colleagues, supporting them in reaching their full potential.
Identifying and solving potential issues and acting as an interface between departments
Provide expert challenge to drug projects and role model positive behaviours in exploring new ways of working and scientific development.
Contributing to the analytical strategy within Chemical Development, leading strategic improvements for project delivery, supporting the current and future project portfolio

Crucial skills and experience:

Experience of technical supervision, coaching and mentoring or leading small teams of people or significant scientific projects.
A thorough understanding of key analytical techniques, including chromatography.
Experience in leading sophisticated projects (including handling resourcing, risks, and stakeholders).
Experience in building the regulatory control strategy for drug substance or drug products.
Experience in supporting clinical and/or commercial manufacture and/or working with contract manufacturing organisations.
Ability to think and operate across functional bou