QC Associate Director of Technology
US - Mt. Vernon - IN, United States
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.The AstraZeneca Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets and capsules for over 60+ markets. The Mt Vernon site is complex, the largest AZ production site in the US with over 700+ employees. We are located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state. The Mt. Vernon site is both collaborative and Inclusive. We have several employee resource groups (ERGs) onsite that are aimed at promoting, celebrating, and educating employees about diversity, inclusion, philanthropy, networking, etc. Each of these groups provide employees with opportunities for interactive and engaging events and initiatives which enhance professional development and provide opportunities to engage with likeminded co-workers.
It is important to us that each employee feels welcome to bring their whole self to work every day. Here is a sneak peek of some of “perks” the MTV site offers: on-site fitness center with access to a personal trainer, on-site walking trail, walking desk, on-site basketball court, ping pong, massage chair, lunch & learns, sustainable & ergonomic office working environment, tuition reimbursement, training/ lifelong learning opportunities, book club, dining center with hot meals, snack market, free coffee and hot tea, climate controlled work environment.
Are you ready to lead the charge in optimizing technology delivery within the MTV QC laboratory? As the QC Associate Director of Technology, you'll be at the forefront of integrating process analytical technologies (PAT) to enable real-time release. Your expertise will drive business insights through data manipulation and analysis using statistical, machine learning, and AI methodologies. You'll oversee analytical transfer, model maintenance, and updates for PAT applications, while exploring innovative approaches like robotics to enhance lab efficiency. Collaborating with various teams, you'll identify and implement digital and PAT opportunities to continually improve MTV Operations. Your role will also ensure QC activities are well-represented in the introduction of new manufacturing technologies.
Accountabilities:
- Develop and implement proactive Human Operation Performance systems throughout the organization.
- Lead efforts to evaluate systems to identify and eliminate error traps.
- Collaborate with lab management, analysts, and scientists to develop digital use cases.
- Perform analytical technology transfer of spectroscopic models, model maintenance, and updates for PAT support.
- Work closely with operations, engineering, sister-site colleagues, and technical experts on continuous manufactured products.
- Apply AI tools to develop factory dashboards as per business requirements.
- Support site digital projects using low code systems like Power Apps and Tulip.
- Collaborate with Lean team to enhance performance analytic reports.
- Implement site analytic-driven use cases.
- Structure and standardize site digital platforms.
- Master digital tools for complexity development.
- Coordinate digital skill and tools deployment.
- Utilize Lean concepts to drive lab improvements.
- Lead or support Tech Transfer activities for the QC Lab.
- Lead or support Equipment Qualification process for the QC Lab.
- Serve as the primary link between teams regarding emerging technologies and Digital Lighthouse teams.
- Collaborate with QCLT and SQLT members for digital process improvements and risk assessments.
- Stay abreast of regulatory compliance practices and recommend implementation strategies.
- Facilitate initiatives using new technologies, policies, or procedures to improve QC functions.
Essential Skills/Experience:
- Bachelor’s degree in a pharmaceutical-related Science or Engineering field (Chemistry, Microbiology, Computer Science or closely related subjects).
- 5-7 years of experience in quality or engineering-centric roles.
- Strong organizational skills.
- Strong understanding of technical areas related to lab operations (including instrumentation, statistical methods, chemometrics, and quality assurance).
- Ability to analyze and solve complex problems in a cross-functional team environment.
- Use of Data Science modeling tools (e.g., Python, Dataiku, Snowflake, SAP HANA, SQL, OSI Soft Historian).
- Experience integrating process analytical technologies into operations.
- Experience with visualization tools (e.g., PowerBI, PiVision, Javascript, HTML, CSS) and ability to tell a story with data.
Desirable Skills/Experience:
- 5-7 years QC chemistry laboratory experience.
- Ability to explain complex methods and techniques to a non-technical audience.
- Experience in manufacturing industry with proven success in deploying digital solutions for business change.
- Self-motivated with high adaptability in ambiguous situations.
- Process Analytical Technology or Real-Time Release experience or similar concepts.
- High proficiency in Tulip, Power BI, Power Apps or similar digital applications in advanced data analytics.
- Strong analytical, problem-solving, and innovation skills.
- Project delivery and business analyst experience.
- Experience working in a global organization with complex/geographical context.
- Experience working in a regulated environment.
- Knowledge of Lean methodologies including process mapping, problem-solving, and continuous improvement.
At AstraZeneca, we are driven by a commitment to quality that goes beyond compliance. Our proactive approach ensures that every batch certified is a testament to our dedication to patient safety. We embrace innovation and leverage cutting-edge technologies to enhance reliability and excellence in our processes. Here, you'll find an empowering environment where your contributions make a tangible impact on patients' lives. With a focus on growth and innovation, AstraZeneca offers endless opportunities for career advancement as we bring new medicines to market globally.
Ready to make a difference? Join us at AstraZeneca and be part of a team that delivers quality medicines to patients worldwide!
Date Posted
26-Jun-2025Closing 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.* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: Chemistry Computer Science Data Analytics Engineering JavaScript Machine Learning Pharma Power BI Python Robotics Snowflake SQL Statistics
Perks/benefits: Career development Fitness / gym Team events
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