Sr. Quality Control Analyst

Pace Analytical Services•Waltham, MA

6d•Onsite

About The Position

Lead formulation and process development for innovative drug products. Provide expert guidance on material and product evaluation using advanced technical knowledge. Design scalable formulations for small molecules and biologics in early-stage clinical trials. Optimize manufacturing processes and interpret analytical data to drive strategic decisions.

Requirements

Bachelor’s, Master’s, or PhD degree in Chemistry, Biology, or a related field (advanced degree preferred).
5+ years in a laboratory setting with demonstrated expertise in analytical methods and formulation development.
3+ years of technical writing experience, including GMP SOP development.
Strong organizational, leadership, and communication abilities.
Ability to manage multiple projects simultaneously; self-motivated and results-driven.
Proficiency with Office 365 and laboratory instrument software
Independent in time management and project planning
Collaborative, detail-oriented, and committed to quality and compliance.

Responsibilities

Analyze and interpret complex chemistry, biochemistry, and formulation data to identify trends and provide actionable insights to management and/or clients.
Develop, validate, and transfer analytical methods; perform routine and advanced testing using instruments such as HPLC, GC, LC-MS, FTIR, and ddPCR.
Design and develop robust, scalable formulations for small molecules and biologics in early-stage clinical trials; optimize manufacturing processes for drug products.
Write and review GMP SOPs
Conduct analytical testing following SOPs, regulatory guidelines, and GMP standards.
Train and mentor team members on analytical methods, instrumentation, and best practices, as required
Collaborate across teams to improve efficiency and deliver high-quality results.
Promote a positive, customer-focused environment aligned with Pace®’s mission.