Associate Scientist, Analytical Sciences, GMP

Job Title: Associate Scientist, Analytical Science, GMP

Location

Gaithersburg, MD.

Introduction To Role

Are you ready to dive into the world of biopharmaceuticals and make a real impact? As an Associate Scientist in Analytical Science, GMP, you'll be part of a dynamic team responsible for providing analytical support for clinical stage biopharmaceutical products. Your work will be crucial in ensuring compliance with GMP regulations, managing lot release and stability programs, and facilitating analytical tech transfer. Collaborate with experts across Analytical Sciences, Clinical Supply Chain, CMC, and Quality Assurance to drive innovation from pre-IND to BLA stages.

Accountabilities

• Work collaboratively within a team to achieve project targets efficiently.
• Assist in developing and validating methodologies to meet project needs.
• Record data meticulously and deliver clear reports.
• Handle routine tasks and resolve issues independently.
• Engage in transactional work across various areas.
• Train others in procedures and practices.
• Enhance personal knowledge in scientific areas.
• Communicate progress and challenges effectively.
• Ensure adherence to Safety, Health & Environment (SHE), quality, and compliance standards.
• Perform clinical GMP operations within defined scopes such as laboratory testing and sample management.
• Conduct GMP testing for biopharmaceutical products following cGMP practices.
• Support method development and technology evaluation.
• Manage samples per GMP procedures, interacting with customer and partner groups.
• Coordinate GMP compliance and audit support.
• Participate in Analytical Tech Transfer testing.
• Maintain laboratory equipment according to procedures.
• Engage in quality investigations as needed.
• Prepare data for reports and presentations for internal meetings and regulatory filings.
• Assist in authoring and reviewing SOPs, protocols, reports, and documentation.
• Support process improvement activities.
• Participate in cross-functional teams.

Essential Skills/Experience

• The candidate will have 0-5 years of experience after receiving a bachelor’s degree.
• A bachelor’s degree in chemistry, biochemistry, or related field is required.

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), electrophoresis (cIEF, CGE), immunoassay (ELISA), bioassay (cell-based potency, flow cytometry), or compendial (pH, osmolality) 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.

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.

At AstraZeneca, we are driven by curiosity and courage to explore the unknowns of science. Our commitment to making a difference fuels our passion for innovation as we work towards treating some of the world's most complex diseases. With a focus on collaboration and inclusivity, we unite diverse expertise from academia, biotechs, and industry to create impactful solutions. Here, you'll find opportunities for lifelong learning and career development as we push the boundaries of science to deliver life-changing medicines.

Ready to make your mark in the world of biopharmaceuticals? Apply now to join our team!

The annual base pay (or hourly rate of compensation) for this position ranges from $71,701.60 - 107,552.40 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales 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 pay (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

27-Aug-2025

Closing Date

09-Sep-2025

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.