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AstraZeneca · 10 hours ago

Senior Scientist

Durham, NC

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

AstraZeneca is a global biopharmaceutical company dedicated to delivering innovative medicines. They are seeking a Senior Scientist to enhance analytical development capabilities in oral solid dosage forms and support regulatory submission activities, while driving projects through development to commercialization.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Lead and perform analytical method development, validation, product characterization, and routine investigational and clinical release testing, working on inhaled and oral products, as needed

Play a key role in establishing, equipping, and optimizing laboratory setups for oral solid dosage (OSD) testing capabilities

Provide technical and strategic input on analytical issues relevant to OSD and, where required, across other modalities and/or dosage formats (e.g. inhaled, parenteral)

Author and review analytical documentation to support regulatory submissions, ensuring compliance with GMP/GxP expectations including response to regulatory inquiries

Champion laboratory automation technologies to improve efficiency and reliability in sample preparation, method execution, and data analysis

Demonstrate an active interest in using AI /ML and other data science tools to enhance analytical results interpretation and workflow performance

Qualification

Analytical method developmentOral solid dosage formsRegulatory submission experienceGMP/GxP environmentLaboratory automationCollaborative communicationData analytics skillsAI / ML toolsProblem-solving skillsCross-functional collaboration

Required

Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, or a closely related field

Minimum of 8-10 years of experience with a Bachelors degree, or a master's degree and a minimum of 4-6 years of experience

Minimum of 8 years experience working with oral solid dosage forms

Strong background in analytical development for oral solid dosage forms

Demonstrated experience in method development, validation, and application in the pharmaceutical industry

Confirmed experience with regulatory submission processes and writing/reviewing analytical sections with response to regulatory inquiries

Hands-on proficiency with workflow optimization, experience with automation is preferred

Excellent organizational, problem-solving, and collaborative communication skills

Experience working in a GMP/GxP environment

Strong people, organizational, and communication skills (both written and oral)

Preferred

Exposure to analytical strategies for portfolios that vary across modalities and/or dosage formats, including but not limited to oral solid and inhaled products

Familiarity or interest in applying data science tools, including AI / ML, to advance analytical interpretation and data flow

Experience collaborating in cross-functional global teams

Consistent track record in analytical method lifecycle management

Experience with validation life cycle management of laboratory automation technology to meet GxP requirements

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)