Scientist - Analytical Bioassay

The successful candidate will develop and deliver robust and fitforpurpose 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 crossfunctionally and support regulatory filings for INDs up to and including BLAs.

The candidate will be independent selfmotivated and eager to tackle a broad range of responsibilities. This fulltime 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 noncellbased 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 bispecifics.

• Identify evaluate and implement cuttingedge 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 crossfunctionally between Research and Development departments.

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

Education

BS with 57 years of relevant experience

MS with 35 years of relevant experience

Required Skills:

• The successful candidate will have indepth understanding and handson 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 handson 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 crossfunctionally

• Excellent organization skills detailedoriented 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 jobrelated knowledge skills and experience. In addition our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm 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 atwill 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.