Senior Scientist - MS&T Analytical Team - Cell based assay SME

Would you like to use your expertise in cellular assay techniques including the development and validation of robust, innovative cell-killing assays for supporting clinical studies at our new Rockville Cell Therapy facility? If so, our Senior Scientist - MS&T Analytical Team - Cell-based assay SME would be a great fit for you!

As cell therapy cell-based assay SME, you will lead the transfer and implementation of all cell-based assays related to cell therapy drug product batch release and product characterization to support cell therapy clinical development and commercialization.  The ideal candidate will have extensive technical expertise in assay development, validation of cell-based assays as well as bioanalysis.

Your areas of responsibility in assay development, optimization, and validation of high-complexity cell-based assays using state-of-the-art instrumentation support pre-clinical and clinical studies. You will also contribute to tech transfer to established internal and external partners and be called upon to review data to ensure assays meet regulatory expectations or are fit for purpose including troubleshooting and data analysis. You will be encouraged to provide scientific leadership to junior staff and develop strong intra and inter-department collaborations. You will contribute to the implementation of advanced bioanalytical techniques across all aspects of the AZ portfolio within cell therapy network units. Working with a dynamic team in a matrixed environment you will need to manage partner expectations, and input to project strategy and delivery while being the main collaborator with experienced and highly skilled bioanalytical scientist colleagues. You will have the opportunity to have an immediate and lasting impact on our diverse pipeline.

What you will do:

• Work collaboratively within the cell therapy technical operations (CTTO) group, analytical development, and RMC QC to manage the analytical transfer to QC operation.

• Ensure that the analytical GMP laboratory is efficient and compliant with regulatory, industry, and AstraZeneca standards.

• As a key member of the MS&T analytical sciences team, you will provide strategic direction to ensure GMP compliance is met in all analytical activities.

• Lead and develop a team of scientists responsible for GMP lot release and stability testing, management of critical reagent and stability-related activities, sample chain of custody, and analytical tech transfer.

• Drive lot release activities to maintain short vein-to-vein times.

• Represent the analytical GMP function in cross-functional leadership team meetings related to manufacturing, analytical development, compliance, and lot release.

• Author, review, and approve SOPs, protocols, reports, and other relevant documentation.

• Represent RMC MS&T Analytical Sciences during regulatory and internal inspections.

• Provide bioanalysis in support of GxP or GxP-like studies. Review and approve bioanalytical data and reports to ensure quality and integrity.

• Author, review and/or approve key documents such as: comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.).

• Collaborate effectively to ensure productive interactions with all partner groups.

Minimum Qualifications:

• Masters/PhD in virology, immunology, molecular biology or related fields.​Masters Degree with 5+ years of experience or PhD with 2+ years of post-doc experience.  

• Proven experience as a subject matter expert in cellular assay techniques including the development and validation of robust, innovative cell-killing assays for supporting clinical studies.

• Design, develop, validate, and troubleshoot assays to ensure they are in line with regulatory expectations or fit for purpose.

• Demonstrate strong accountability, organizational and interpersonal skills, and apply scientific and technical experience.

• Proven laboratory experience with following SOPs, GxP regulations, GxP documentation, and knowledge of regulatory guidance

• Ability to handle multiple projects and/or tasks concurrently in a fast-paced environment.

• Ability to train and mentor junior staff.

• Proven publication and presentation record

• Exceptional verbal and written communication skills

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