Position:Analytical Quality Control Method Development Specialist
Location:Greater Boston, MA (Onsite)
Length:6 months
Job Description:
Our client is seeking a detail-oriented and technically skilled Analytical Quality Control (QC) Method Development Specialist to join a dynamic and growing team. This role is pivotal in supporting QC analytical methods for the validation and transfer of methods in biologics testing. The ideal candidate will have experience in authoring method validation protocols, writing comprehensive reports, and ensuring that all activities comply with global regulatory standards, including ICH, FDA, and EMA guidelines. If you are an experienced professional with strong technical writing abilities and analytical expertise, we invite you to apply.
Essential Duties and Responsibilities (but not limited to):
- Provide non-laboratory support for the QC analytical methods functions, specifically for method validation and method transfer projects.
- Author and review analytical method documentation to support QC release and stability testing of biologics.
- Write and review method validation protocols and reports to facilitate smooth technology transfers, ensuring compliance with ICH, FDA, EMA, and other regulatory standards.
- Create, review, and revise comprehensive method validation protocols and reports, ensuring accuracy and adherence to regulatory requirements.
- Focus on analytical methodologies for potency, impurities, content, and identity attributes in biologics (i.e., recombinant proteins, antibodies, ADCs, fusion proteins, enzymes).
- Author documentation related to cell-based assays, residual Protein A, host cell proteins, residual DNA, and protein determination methods.
Qualifications:
- Strong technical writing experience in Quality Control and Regulatory departments, with hands-on experience authoring method validation documents.
- Expert knowledge in data analysis and the ability to interpret complex analytical results.
- Proven experience with test methods and method validation for both internal teams and external partners.
- Proficient in maintaining laboratory compliance through detailed documentation practices.
- Experience with Electronic Laboratory Notebooks (ELNs) and electronic data storage systems.
- Strong written, verbal, and interpersonal communication skills, with a proven track record of success in team environments.
- Familiarity with LIMS and Empower software platforms.
- Ability to document assay trends periodically, ensuring compliance while improving operational efficiency.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
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- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 'Employee's Choice - Best Places to Work' by Glassdoor.
- Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine.
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Digital Prospectors
Feb 24, 2025