Scientist - Analytical Bioassay

The successful candidate will develop and deliver robust and fit-for-purpose biological assays to enable theprogression ofbiotherapeutic 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 willrepresent bioassay development withinvarious 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-basedbioassays. Assays need to be mechanism of action (MOA)reflective to enable product characterization as well as meet GMP release and stability testing criteria. Biotherapeutic modalitiesinclude:traditional mAbs, ADCs andbi-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-depthunderstanding and hands-on experience withdeveloping assays to measurevarious 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

• Excellentorganizationskills, detailed-oriented, and strongwritten and oral communicationskills 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.