Job Title: Associate Principal Scientist
Introduction to role:
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's outstanding skills with those of people from all over the globe.
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.
We are currently looking for an experienced Associate Principal Scientist - Analytical to play a key role in our 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 we deploy our 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. We work closely with many technical functions across Global Operations providing the ability to drive science and build capability within our organization and our ways of working.
Accountabilities:
* Responsible expert for a major commercial product or group of products related to the Analytical subject matter area e.g. Oral Solid Dosage formulations, parenterals formulations, Oligonucleotides etc.
* 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.
Essential Skills/Experience:
* Bachelor's Degree with 8 years of professional working experience in a relevant field such as pharmaceuticals, chemistry, biotechnology, or life sciences
* 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.
Desirable Skills/Experience:
* Master's Degree with 5 years of experience or PhD with 3 years of experience in a relevant industry such as pharmaceuticals
* Experience in or exposure to multiple disciplines in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
* Previous experience and training in Lean, problem-solving tools and have experience in data analysis and interpretation.
* Strong leadership skills and behaviors with demonstration of being able to work across different functions.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca offers an environment where you can break new ground and leave a collective legacy. Here you will have the opportunity to play a role in evolving Supply Chain, reimagining how we do things and creating a collective legacy. Unrivalled leaders in this space, we always do it the right way with sustainable lifecycle management. There's no better time to take ownership and reshape the entire ecosystem, from technological advances through to developing more ethical approaches to our work.
Ready to make a difference? Apply now!
Date Posted
13-Nov-2024Closing Date
12-Dec-2024Our 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.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.