Senior QC Analyst: Lead Formulation & Analytical Methods

RXinsider LTD.; Waltham (MA); On-site; USD 105,000 - 120,000; Full time

Job summary

Pace is seeking a lead formulation and process development scientist to guide material and product evaluation and design scalable formulations for small molecules and biologics in early-stage trials.

The role involves interpreting analytical data, optimizing manufacturing processes, and writing GMP SOPs while mentoring the team and collaborating across functions to deliver high-quality results in a fast-paced environment.

Qualifications

• 5+ years in a laboratory setting with analytical methods and formulation development.
• 3+ years of technical writing experience, including GMP SOP development.

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.

Skills

Organizational skills

Leadership

Communication skills

Time management

Project planning

Office 365

Laboratory software

Education

Bachelor's/Master's/PhD in Chemistry or Biology

Tools

HPLC

GC

LC-MS

FTIR

ddPCR

Job description

Pace is seeking a lead formulation and process development scientist to guide material and product evaluation and design scalable formulations for small molecules and biologics in early-stage trials.

The role involves interpreting analytical data, optimizing manufacturing processes, and writing GMP SOPs while mentoring the team and collaborating across functions to deliver high-quality results in a fast-paced environment.