Associate Scientist, Analytical Sciences, GMP
Associate Scientist, Analytical Sciences, GMP
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$ 71701 - 107552
1 Vacancy
Job Description
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 youll 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 bachelors degree
A bachelors required; 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 -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 worlds most complex diseases. With a focus on collaboration and inclusivity we unite diverse expertise from academia biotechs and industry to create impactful solutions. Here youll 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 $71701.60 - 107552.40 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 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-2025Closing Date
09-Sep-2025Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.
Required Experience:
Director
Employment Type
Full-Time
