USA – Quality Control Chemist – IV

SGS_JOB_3421

Business Support
 Washington
Method Transfer
Method Validation
cGMP
Analytical Chemistry
QC
Data Analysis
Technical Writing
Regulatory Compliance

Contract - 12 Months Contract

Location (mandatory): Bothell, WA, USA 98021 Small Description: The Method Transfer Lead (MTL), Scientist, is a Quality Control expert within the QCSV group responsible for ensuring analytical method transfer and/or validation activities comply with cGMP and regulatory expectations. This role serves as an individual contributor with a strong understanding of analytical method transfer, validation strategies, and regulatory requirements. The position supports internal and external method transfer activities while collaborating with global QC labs and cross-functional teams. The scientist authors and reviews technical documentation, analyzes complex data, and represents QC on project teams. The role requires strong scientific judgment, project management skills, and effective communication to support program and company goals.

Job Responsibilities:

  • Support the Project Lead for method transfer and/or validation activities internally and externally for assigned programs
  • Author and/or review protocols and reports for method transfer, method validation, method bridging, and other associated technical development reports
  • Plan, manage, and track method transfer and/or method validation deliverables
  • Collaborate with internal global QC testing sites/labs, external testing labs, project leads, and functional representatives
  • Review method transfer and validation assays, perform data verification, conduct non-routine data mining, and execute in-depth data analysis
  • Represent Quality Control in intra-departmental initiatives and cross-functional project teams in support of program and company objectives

Skills:

  • Expertise in designing and evaluating method validation and method transfer studies, including partial re-validation, co-validation, and cross-validation approaches
  • Strong technical writing skills for authoring analytical methods, validation studies, transfer protocols, and reports
  • Expert knowledge of scientific principles related to monoclonal antibodies (mAb), ADCs, vaccines, and gene therapy
  • Strong analytical mindset with experience in analytical and plate-based methods
  • Experience with analytical separation techniques such as SEC, icIEF, and CE-SDS (preferred but not required)
  • Excellent project management skills with the ability to manage multiple projects simultaneously
  • Strong data interpretation, troubleshooting capabilities, and sound scientific judgment
  • Effective time management, attention to detail, and goal-oriented work ethic
  • Strong communication skills with the ability to lead teams and influence cross-functional stakeholders
  • Solid understanding of regulatory guidance and requirements (ICH, CFR, and general regulatory guidance) related to method transfer, validation, and regulatory submissions such as IND, IMPD, BLA, and NDA

Education/Experience:

  • Bachelor’s degree in Life Sciences (Analytical Chemistry, Biology, Biochemistry, Pharmaceutical Science, or related discipline); post-graduate degree preferred
  • 8–10 years of relevant experience in pharmaceutical or biological drug product development, analytical chemistry, and/or Quality Control within a regulated biotechnology or pharmaceutical company, with progressive levels of responsibility

Related Jobs

Estimator III

Business Support
 Washington
12 Months

Location : Richland, WA 99352 Small Description: The Estimator III (Principal) is a senior-level estimating professional responsible for developing, reviewing, and communicating comprehensive project and program cost estimates in support of project management at the Columbia Generating Station (CGS). This role partners with engineering, planning, procurement, and construction teams to deliver accurate estimates across all phases of project development while continuously improving estimating and scope management processes in a highly regulated industrial and nuclear environment.

Estimate
Contract.

Customer Support Analyst

Business Support
 Texas
12 Months

Location : Houston Texas Small Description: The Customer Support Analyst is responsible for supporting customers through accurate data entry, utility outreach, and timely resolution of billing and payment-related inquiries. This role requires strong attention to detail, analytical thinking, and a customer-focused mindset to ensure customers are onboarded efficiently while meeting established performance metrics in a fast-paced, remote work environment.

Customer Service
Data Entry
Excel.

Construction Manager

Business Support
 Pennsylvania
12 Months

Location : Berwyn PA Small Description: Experienced Construction Manager / Construction Supervisor needed to support major transmission and substation projects at the Byron, IL site. This role involves overseeing the construction of an electric switchyard within a substation environment, providing field supervision, and ensuring safe, efficient execution of EPC construction activities. The ideal candidate has strong commercial construction experience, hands-on knowledge of electric equipment installation, and experience with transmission and distribution systems. Prior experience at the Byron station and familiarity with nuclear environments is preferred.

Construction
Transmission.

Senior Professional Application Designer

Business Support
Remote
3+ Months Contract (Contract-to-Hire based on performance)

Description: As a Batch Developer, this role involves design, development, testing, and support activities across the full software development lifecycle. The Senior Professional Application Designer will investigate and resolve complex business and technical integration issues and focus on specific products or technology platforms. The role functions independently within a business area and contributes at the enterprise level by influencing technical decisions throughout project phases. The team requires an experienced Application Designer with strong batch processing and healthcare domain expertise to support enterprise-level Medicaid Claims systems. This position is intended as a long-term opportunity with potential conversion to full-time employment based on performance.

Design
develop
test
debug
implement

Supply Chain Analyst II

Business Support
 North Carolina
6 months

Location : Remote (onsite training in Charlotte, NC 28217) The Supply Planner is responsible for balancing supply and demand to ensure product availability while controlling inventory and supporting operational efficiency. This role partners closely with demand planning, procurement, manufacturing, and logistics teams to create and maintain supply plans that meet business goals.

Demand planning
procurement
manufacturing
ERP systems
SAP or Oracle

Insurance Verification Specialist or Case Management Assistant

Business Support
Remote
3 months

Seeking professionals with experience in health insurance or Medicaid verification to support Medicaid-eligible members under the HIPP / Premium Assistance Program. The role involves insurance verification, eligibility documentation, case maintenance, and high-volume customer interaction.

Insurance verification
health insurance
Medicaid verification
Customer service
and HIPP / Premium Assistance Program

Senior Professional Application Designer

Business Support
Remote
6+ Months

Designs, develops, installs, tests, and documents complex application software including server, client, and web-based components. Contributes to the design and delivery of technical architecture solution components and provides technical guidance to less experienced personnel. May provide technical consulting support on complex initiatives while ensuring adherence to industry and organizational standards. Background/Need: Team requires an experienced Application Designer to support enterprise-level application design and development efforts. This role supports complex system initiatives, ensures high-quality application architecture, and improves development efficiency while working in a fully remote, fast-paced environment during EST hours.

SQL
Linux commands
IWS
Software Development Life Cycle (SDLC)

Health Insurance Verification / Insurance Verification Specialist

Business Support
 Georgia
3 months

Location : Tucker, GA 30084 (Remote) Seeking professionals with experience in health insurance or Medicaid verification to support Medicaid-eligible members under the HIPP / Premium Assistance Program. The role involves insurance verification, eligibility documentation, case maintenance, and high-volume customer interaction

Insurance Verification
Health Insurance

Global Licensing Manager

Business Support
 California
$50-$90
03 months

Location (mandatory): El Segundo CA USA 90245 Seeking a professional and detail-oriented Global Licensing Manager to support in-licensing programs across multiple categories. This individual will manage relationships with external partners, negotiate licensing agreements, and ensure brand integrity and alignment across product lines and markets. This is a critical role that works cross-functionally with Product Marketing, Brand Marketing, Legal, Royalty Accounting, Consumer Products, Film, TV, and Sales to drive company growth within toys and support other lines of business.

Licensing
contract negotiation
Hardlines
logo

At SGS Consulting, we go beyond resume-job matches, creating meaningful connections and pathways for individuals to thrive in defining careers.


2025. All right reserved.
logologologologo