Sr. Quality Control Analyst

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

Shift

Monday through Friday, 8:00AM - 5:00PM

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

Description

• 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.

Compensation: $105,000.00 - 120,000.00 per year

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.

Requirements

• Education: Bachelor's, Master's, or PhD degree in Chemistry, Biology, or a related field (advanced degree preferred).
• Experience:
  • 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.
• Skills:
  • 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
• Mindset: Collaborative, detail-oriented, and committed to quality and compliance.

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits

When you join Pace®, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer

Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.