Associate Scientist, Analytical Sciences, GMP

AstraZeneca • Gaithersburg, MD

85d • $71,701 - $107,552

About The Position

Are you ready to dive into the world of Analytical Sciences within GMP regulations? Join our dynamic team responsible for supporting clinical stage biopharmaceutical products. We manage lot release and stability programs, reference standards, critical reagents, and more. Collaborate with experts across multiple analytical disciplines such as chromatography, electrophoresis, immunoassay, bioassay, and device functionality methods. Work closely with Analytical Sciences development personnel, Clinical Supply Chain, CMC, and Quality Assurance throughout all stages of clinical development.

Requirements

• A bachelor’s or master’s degree in chemistry, biochemistry or related field is required.
• 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.

Nice To Haves

• 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.

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 standards.

Benefits

• 401(k) plan
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees