Scientist III, Biologics SME

Job Title:

Scientist III, Biologics Subject Matter Expert

Job Description

We are seeking a mid-career scientific professional with expertise in biologics, microbiology, and compendial laboratory testing. This role involves serving as a subject matter expert responsible for translating, reviewing, and validating USP procedures for digital deployment. The successful candidate will transform complex laboratory procedures into structured, executable workflows and collaborate with scientific content, quality, informatics, and product teams to support vendor-neutral laboratory software environments.

Responsibilities

+ Serve as a scientific SME for USP General Chapters , , , and , interpreting compendial procedures for digital implementation.

+ Create, review, and validate structured method content for scientific accuracy, procedural completeness, calculations, acceptance criteria, materials, equipment, and alignment with source documentation.

+ Apply laboratory SOP and workflow expertise to ensure procedures reflect practical execution in regulated laboratory and manufacturing environments.

+ Perform scientific quality review, identify interpretation risks or discrepancies, and recommend improvements to content development and review processes.

+ Collaborate with laboratory informatics and product teams to support workflow design, metadata capture, and implementation across LIMS, ELN, LES, and related systems.

+ Support alignment with laboratory data standards, machine-readable content models, and structured data principles.

Essential Skills

+ Bachelor's degree in Biology, Microbiology, Biochemistry, Biotechnology, Life Sciences, or a related scientific discipline; advanced degree preferred.

+ 5+ years of experience in biologics, microbiology, compendial testing, analytical development, quality control, or regulated laboratory environments.

+ Demonstrated expertise with USP General Chapters , , , and , including interpretation and application of compendial methods.

+ 3+ years of experience authoring, reviewing, revising, or approving laboratory SOPs, test methods, work instructions, or related controlled documentation.

+ Working knowledge of laboratory quality systems, data integrity requirements, laboratory workflows, and analytical instrumentation.

+ Experience using laboratory information systems such as LIMS, ELN, LES, CDS, or similar platforms.

+ Ability to translate laboratory procedures into structured, digitally executable workflows while maintaining scientific accuracy and compliance.

+ Strong scientific writing, review, analytical, and cross-functional collaboration skills.

Additional

Skills & Qualifications

+ Advanced degree (MS or PhD) in Microbiology, Biotechnology, Biochemistry, Biological Sciences, or a related field.

+ Experience in microbiological testing, biologics development, cell-based assays, protein characterization, or sterile manufacturing environments.

+ Experience supporting laboratory digitization, workflow automation, or scientific content transformation initiatives.

+ Development expertise with structured data formats, data standards, metadata management.

+ Familiarity with FAIR data principles, laboratory informatics frameworks.

+ Experience applying data science, analytics, or data visualization techniques to laboratory, quality, or analytical datasets.

+ Familiarity with AI and machine learning applications for scientific content management, laboratory operations, workflow automation, or knowledge extraction.

+ Working knowledge of Python, SQL, Power BI.

Work Environment

The position offers remote working opportunities with a preference for candidates located in the DMV area. The role operates on East Coast hours, providing flexibility while ensuring collaboration with teams.

Job Type & Location

This is a Contract position based out of Rockville, MD.

Pay and Benefits

The pay range for this position is $52.11 - $74.25/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

- Medical, dental & vision
- Critical Illness, Accident, and…