Associate Director, Bioanalysis (CPSS Cell Therapy) at AstraZeneca

Gaithersburg, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Jan, 26

Salary

201867.0

Posted On

01 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Bioanalytical Strategies, Clinical Assay Endpoints, Assay Development, Data Interpretation, Cross-Functional Collaboration, Cell Therapy Biology, Regulatory Requirements, Project Management, Data Analysis, Visualization Software, Immunogenicity Assessments, Clinical Trials, Tech Transfer, Scientific Quality, Presentation Skills, Stakeholder Communication

Industry

Pharmaceutical Manufacturing

Description

Position Summary: Are you ready to make a significant impact in the field of cell therapy? Join our dynamic team at AstraZeneca as an Associate Director within Clinical Pharmacology and Safety Sciences (CPSS) Cell Therapy team, where you will lead the design and implementation of robust bioanalytical strategies to support clinical assay endpoints. Your expertise will help advance our cell therapy pipeline and transforming the lives of patients. Responsibilities Lead design and implementation of bioanalytical strategies to support clinical assay endpoints, including PK/CK/PD, immunogenicity and biomarkers related to cell therapy products to support the AstraZeneca cell therapy pipeline. Evaluate scientific and operational capabilities and establish partnerships with selected specialty laboratories and CROs for generation and analysis of bioanalytical data. Lead assay development, qualification/validation and tech transfer of cell therapy-related bioassays at CROs or using internal capabilities. Interpret and integrate complex datasets within programs and across the cell therapy portfolio. Provide written and verbal updates to key stakeholders. Contribute to publication strategy, prepare data for publication or presentations in internal/external scientific conferences. Essential Experience PhD degree in immunology, cellular and tumor biology or a related field with 7+ years of relevant industry experience with background in cell therapy Demonstrated experience managing/directing analysis of clinical biospecimens to support clinical trials. Experience with regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments Evaluate and interpret complex data sets using analysis and visualization software (i.e. Cytobank/OMIQ/FCS Express, Tableau/Spotfire/JMP). Work cross-functionally and collaboratively with project stakeholders. Experience with cell therapy biology and up to date with latest analytical methods applicable to characterization of cell therapy products and mechanism of action. Understanding of global regulatory expectations and analytical requirements to support regulatory filings. Experience managing assay development teams, overseeing tech transfers, scientific quality and study conduct internally and at CROs. Interpret complex datasets to communicate results verbally, in writing and in presentations adapting to different audiences. Ability to prioritize multiple projects and task concurrently in a fast-paced environment. The annual base salary for this position ranges from $134,578.40 - $201,867.60. 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), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Our Benefits: Benefits offered include: A qualified retirement program [401(k) plan] Paid vacation, holidays, and paid leaves 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. #celltherapy #LI-Onsite Date Posted 31-Oct-2025 Closing Date 06-Nov-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.

Responsibilities

Lead the design and implementation of bioanalytical strategies to support clinical assay endpoints for cell therapy products. Evaluate scientific capabilities and establish partnerships for bioanalytical data generation and analysis.