Global QC Lead - Process Analytical Technology
Location: Butler County, Ohio, Cheshire East, Gaithersburg, Maryland, Mount Vernon, Indiana
Job Type: Full time
Are you ready for an opportunity to join AstraZeneca in a lead role with a focus on leading the deployment and integration of enhanced control strategies for continuous manufacturing? Are you seeking a leadership opportunity to push the boundaries of science, transforming our operation to the factory of the future which incorporates advanced analytical capabilities in process analytical technology (PAT) and predictive methods of analysis, and growing our science and technology capabilities?
We are looking for a talented Global QC Lead - Process Analytical Technology (PAT), to strengthen our capabilities in the area of analytical science towards control strategies developed using an enhanced approach. If you believe that you have operations Quality and manufacturing knowledge based in science then join us in our Global Quality & Stability organization! This role will have global responsibilities and can be based at our site in Sweden or globally.
Here at Global Quality & Stability, we work at the forefront of advanced technologies and digitalization with a focus on delivering high quality medicines to our patients leveraging our talented and diverse global team. We are always looking for creative and innovate ways to ensure we can consistently meet our patient’s needs.
Our organization, The Global Quality & Stability group owns, the delivery of Global Quality Control Strategy to improve and sustain the Global QC operation with processes to enable efficient delivery of safe and effective medicines to patients. We proactively integrates quality into our supply chain advancing beyond our compliance license to operate. We are accountable for the following areas:
Global Quality Control
Global Materials Certification
What you’ll do
This position will give you the opportunity to work in a dynamic and enthusiastic atmosphere, whilst leading in the deployment and application of process analytical technologies to enable enhanced control strategies in support of AstraZeneca’s product portfolio. In this role you will work closely with a team of colleagues in a multi-skilled environment to operationalize in our commercial production facilities ensuring appropriate quality management systems are in place to support using of PAT methods including model predictive controls, advanced process control, multi-variate data analytics, and predictive models. Continuous improvement will be at the core of everything you do, and you will support the PAT Strategy and advanced process control (including model predictive controls/APC/MVDA) to ensure that our organization is on the frontline of emerging technologies and tools, including continuous manufacturing & digital transformation. This position will give you the chance to lead and set clear direction for the organization in “cutting edge” areas , advising others at a high level, and being at the fore-front of external interactions.
The role will deliver on the following objectives:
- Application of PAT to capitalize on product lifecycle management opportunities.
- Identification of manufacturing process monitoring step data and correlated to QC results, that can be used for regulatory submissions and business cases for change
- Product launch considerations with PAT from development through to regulatory submission
- Sustainability improvements through PAT applications
- Lead time improvements associated with PAT control and NPI launches
- Industry benchmarking and external advocacy position papers
- Serve as an expert/leader within Global Quality & Stability Organization, mentor colleagues in the area of enhanced control strategies and Process Analytical Technology (PAT), operationalizing our PAT Strategy transforming our business.
- Provide direction and advice on new science and technology within Quality Operations of enhanced control strategies with PAT, to take part in tech transfer of these advanced analytical methods.
- Continue to drive scientific excellence in the area of process analytical technology and advanced process control methodologies and technologies within the company. Provide leadership, coaching and mentorship to the QC Network other cross-functional colleagues.
- Contribute to regulatory documentation and post approval submissions, applying your understanding of quality and operational knowledge to requirements from medical authorities.
Essential for the role
The Global QC Lead - PAT will implement new in-line, on-line and at-line real time or “near” real time analytical technology to support commercial manufacturing processes for a wide variety of molecules and modalities. Have a strong technical background in spectroscopy (Raman, FTIR, NIR, impedance), multivariate (chemometrics) modeling skills and/or process control for pharmaceutical API or Pharmaceutical processing and hands-on-experience and in-depth understanding of PAT concepts and its application to API or Pharmaceutical.
Qualifications for this role include:
- Holds a minimum of Degree level in Pure or Applied Science (e.g., Biology, Chemistry, Pharmacy, Chemical Engineering) or other relevant scientific discipline and experience.
- A minimum of 10 years’ experience in the pharmaceutical / bio-pharmaceutical industry, including having direct site experience in Quality and GMP associated with the manufacture of Drug Product or Drug Substance.
- Sound knowledge and understanding of the principles and concepts of GMP, quality and compliance management, quality risk management and performance evaluation and control.
- Familiar with FTIR, NIR, Raman, particle size, UV and other measurement techniques that are suitable for PAT applications. Hands-on-experience and in-depth understanding of PAT concepts and its application to pharmaceutical development. Demonstrated experience with statistics, chemometrics, programming and data modeling packages such as Matlab, Unscrambler, Eigenvector PLS Toolbox, JMP etc.
Desirable for the role
- Significant experience within the field of Process Analytical Technology (PAT), advanced process control and/or chemometrics , analytical sciences or similar discipline, ideally with specialism in an area relevant to application of PAT to support continuous manufacturing. Demonstrated leadership with direct/indirect management of highly skilled workforce is highly desirable.
- Demonstrated delivery of process analytical technology including advanced process control/MVDA, model predictive controls in support of pharmaceutical continuous processing. Well versed in ICH Q8, Q9, Q10, Q11 and Q13 guidance’s, Quality by Design principles, implementation of enhanced approaches for project/product specific control strategies.
- Experience in technology transfer and commercial manufacture using continuous processing.
- Experience in providing support for regulatory submissions (e.g. Investigational New Drug Applications, New Drug Applications).
There are many opportunities to develop yourself and your career. From our diverse portfolio and teamwork to our cutting-edge innovations – it’s a place for lifelong learning. Ultimately, it’s more than a job. We know that our work impacts people with serious conditions, many of whom have no other alternatives. That’s what drives us – the potential to impact over one billion patients worldwide.
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 authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.