Associate Scientist, Analytical Sciences, GMP
Apply NowCompany: AstraZeneca
Location: Gaithersburg, MD 20878
Description:
The Analytical Sciences GMP department (within Research and Development) is responsible for analytical support of clinical stage biopharmaceutical products in accordance with GMP regulations. This includes management of: lot release and stability programs, reference standards and critical reagents, analytical tech transfer, and sample chain of custody. The team engages with analytical development and manages assays across multiple analytical disciplines including chromatography, electrophoresis, immunoassay, bioassay and device functionality methods. Members of the Analytical Sciences GMP department work closely with Analytical Sciences development personnel, Clinical Supply Chain, CMC and Quality Assurance across all stages of clinical development (pre-IND to BLA).
Responsibilities:
Work as part of a team and contribute to design and/or execution of analytical studies to determine the quality and stability of drug substance and drug products.
Participate in analytical method development, method qualification and technical transfer activities.
Execute analytical testing, data review and interpret results according to written procedures.
Author, revise and/or review SOPs, protocols, reports and other relevant documentation.
Train junior laboratory personnel and troubleshoot methods and experiments, as needed.
Maintain laboratory and equipment in accordance with written procedures. Perform analytical quality investigations, as needed.
Participate in/lead cross-functional teams and or process improvement efforts.
Interpret data, generate reports/presentations and communicate progress to immediate peer group and supervisor.
Ensure that work is performed in accordance with appropriate safety, cGMP and AZ
Requirements
Education
A bachelor's or master's degree in chemistry, biochemistry or related field is required Experience The candidate will have 0-5 years of experience after receiving a bachelor's degree or 0-2 years of experience after receiving a master's degree.
Special Skills/ Abilities
Prior experience in a laboratory environment and familiarity with laboratory practices and safety requirements is required.
Prior experience with analytical methods used for characterization of biopharmaceutical and/or cell therapy products, including, but not limited to chromatography (SEC, IEC, and RPLC), compendial (pH, HIAC, osmolality, etc.), electrophoresis (cIEF, CGE) techniques is preferred.
Familiarity with cGMP, ICH and USP/EP requirements is desirable.
Previous experience in a Quality Control environment is desirable.
Ability to work well independently and on teams across multiple functional areas
Self-motivated and possess good interpersonal, collaborative, and communication skills.
Working knowledge of Microsoft Excel, Word, and PowerPoint.
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.
The annual base salary for this position ranges from 71,701.60 - 107,552.40 USD Annual
However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
15-Apr-2025
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.
Responsibilities:
Work as part of a team and contribute to design and/or execution of analytical studies to determine the quality and stability of drug substance and drug products.
Participate in analytical method development, method qualification and technical transfer activities.
Execute analytical testing, data review and interpret results according to written procedures.
Author, revise and/or review SOPs, protocols, reports and other relevant documentation.
Train junior laboratory personnel and troubleshoot methods and experiments, as needed.
Maintain laboratory and equipment in accordance with written procedures. Perform analytical quality investigations, as needed.
Participate in/lead cross-functional teams and or process improvement efforts.
Interpret data, generate reports/presentations and communicate progress to immediate peer group and supervisor.
Ensure that work is performed in accordance with appropriate safety, cGMP and AZ
Requirements
Education
A bachelor's or master's degree in chemistry, biochemistry or related field is required Experience The candidate will have 0-5 years of experience after receiving a bachelor's degree or 0-2 years of experience after receiving a master's degree.
Special Skills/ Abilities
Prior experience in a laboratory environment and familiarity with laboratory practices and safety requirements is required.
Prior experience with analytical methods used for characterization of biopharmaceutical and/or cell therapy products, including, but not limited to chromatography (SEC, IEC, and RPLC), compendial (pH, HIAC, osmolality, etc.), electrophoresis (cIEF, CGE) techniques is preferred.
Familiarity with cGMP, ICH and USP/EP requirements is desirable.
Previous experience in a Quality Control environment is desirable.
Ability to work well independently and on teams across multiple functional areas
Self-motivated and possess good interpersonal, collaborative, and communication skills.
Working knowledge of Microsoft Excel, Word, and PowerPoint.
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.
The annual base salary for this position ranges from 71,701.60 - 107,552.40 USD Annual
However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
15-Apr-2025
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.