Associate Scientist, Analytical Sciences, GMP

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.

The annual base salary for this position ranges from71,701.60 - 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.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.