Role Name: Associate Principal Engineer/Scientist – Parenteral Product Lead, Aseptic Manufacturing

Location: Macclesfield, UK

Closing Date: 19th Feb 2024

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. This is the place to make an impact. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.

We’re currently looking for a hardworking Associate Principal Engineer/Scientist -to play a key role in our Technical Operations Science and Innovation (TOSI) organization. This is a great opportunity to be part of a global organization where you will be responsible for the provision of strategic technical leadership and aseptic manufacturing expertise, for our portfolio of synthetic-molecule commercial parenteral drug products.

TOSI is the on-market technical function of our Pharmaceutical Technology & Development (PT&D) organization. The PT&D Organization is responsible for drug product design, development and technical support for drug products throughout the life cycle. TOSI is a multi-skilled, multi-platform, Global organization providing expert technical support for AstraZeneca commercial synthetic-molecule products.

What you’ll do

In your role as Associate Principal Engineer/Scientist you will help develop a future strategy for the introduction of new aseptic manufacturing technology, driving innovative ways to improve the manufacturing adaptability and efficiency for AZ current and future parenteral product portfolio, including helping to define the capability build required. In addition, you will provide subject matter expertise to commercial manufacturing problem solving and support technical issues to resolution.

We are looking for an aseptic manufacturing technical expert who has experience and capability in technical mentorship and oversight of parenteral manufacturing processes and who is able to identify future regulatory requirements and technology opportunities and trends. Identifying these to define the future standards and opportunities, helping to build business cases, aligning the needs against drivers such as portfolio drivers, productivity, robustness and compliance.

In this role you will need to develop solutions to a diverse range of opportunities and problems requiring sophisticated judgements based on highly developed levels of conceptual thought, strategic vision and analysis.

Your responsibilities will also include:

• Technical leadership and expertise for a portfolio of commercial parenteral products; including supporting product supply strategy projects (capacity expansion, asset transfers etc) and business continuity plans through delivery of the drug product control, manufacturability strategy and product quality risk management activities throughout the lifecycle

• Provision of technical expertise, problem solving skills, and leadership during the resolution of issues impacting supply or manufacturability, including collaborator management

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

• Coaching, development and training of technical authorities across PT&D in subject matter areas

• Ensuring effective collaboration between PT&D, Global AZ Operations and sites, and External Global Partners and Manufacturing sites

• Maintain a technical support model with outstanding customer service for all AZ manufacturing sites and external manufacturing/testing partners that aligns to the Operations vision

Crucial 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 or PhD level in an appropriate subject area with experience relevant to the pharmaceutical industry and have professional credibility, within the business and industry

• Experience in or exposure to multiple fields in CMC and related functions (eg Development, Manufacturing, Global Supply) with a track record of successful project leadership and delivery within a matrix organization

• Have in depth understanding of aseptic manufacturing (domain expert) and also a strong understanding of other multiple areas, such as, analytical, formulation, process engineering, modelling or validation

• Detailed understanding of principles, applications and management of Lean, SHE and cGMP

• Trained in assigned core capabilities for example, but not limited to, documentation practices, quality and regulatory compliance, data integrity and change management.

• Operate at the highest level of risk management

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

Why AstraZeneca

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and teamwork, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

We welcome your application no later than 19th Feb 2024

Date Posted

22-lut-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.