The successful candidate will develop and deliver robust and fit-for-purpose biological assays to enable the progression of biotherapeutic products from research to commercialization.  The candidate will develop, qualify and transfer bioassays to support potency and characterization testing for a diverse pipeline of biotherapeutic modalities. The candidate will represent bioassay development within various teams, collaborate cross-functionally, and support regulatory filings for INDs up to and including BLAs. 

The candidate will be independent, self-motivated, and eager to tackle a broad range of responsibilities. This full-time position within the Bioassay, Biosafety and Impurities Department, within Biopharmaceutical Development, is located in Gaithersburg, Maryland.  

Main Duties & Responsibilities: 

Lead the development, optimization, qualification, and tech transfer of a variety of cell- and non-cell-based bioassays. Assays need to be mechanism of action (MOA) reflective to enable product characterization as well as meet GMP release and stability testing criteria. Biotherapeutic modalities include: traditional mAbs, ADCs and bi-specifics. 

Identify, evaluate, and implement cutting-edge technologies to develop assays. 

Serve as technical lead for developed assays to support potency testing, biological characterization, and CMC studies such as critical quality attribute (CQA) assessments.  

With support of manager, represent bioassay development at analytical and CMC team meetings, as well as interface cross-functionally between Research and Development departments. 

Author and review documents, including assay development reports, SOPs, assay transfer plans/reports, qualification plans/reports. 

Education 

BS with 5-7+ years of relevant experience 

MS with 3-5+ years of relevant experience 

Required Skills: 

The successful candidate will have in-depth understanding and hands-on experience with developing assays to measure various biological activities, including ligand/receptor binding, alteration of intracellular signaling, induction of cell death, and Fc effector functions.  

The candidate should have extensive hands-on experience with 2 or more assay types: ELISAs, reporter gene assays, and cell death and proliferation assays, as well as analyzing and interpreting data from these methods. 

Willing to work collaboratively and cross-functionally   

Excellent organization skills, detailed-oriented, and strong written and oral communication skills in English. 

Experience: 

Experience in CMC analytical and bioassay development a plus 

Experience with authoring and reviewing laboratory procedures, experimental plans, and data analyses with keen attention to details.  

Experience with tech transfer, method qualification, and CMC team representation is highly desired 

Experience authoring and reviewing regulatory filings, such as INDs and BLAs, is a plus.   

GMP experience is a plus  

 
 

The annual base salary for this position ranges from 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.

Date Posted

13-May-2025

Closing Date

20-May-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.