Formulation Associate

redShift•Stockbridge, MA

21h•Onsite

About The Position

Our regulated manufacturing client is seeking skilled Formulation Associates (Level I & II) to support formulation and compounding operations within a GMP environment. This role is responsible for executing production processes, preparing solutions, and operating specialized equipment while maintaining strict adherence to quality and regulatory standards. Working under the direction of the Formulation Supervisor, this position plays a critical role in ensuring safe, accurate, and efficient manufacturing of products while supporting continuous improvement and operational excellence.

Requirements

Formulation Associate I: 0–2 years of experience in a GMP or regulated manufacturing environment
Associate degree in a science-related field or equivalent experience
Formulation Associate II: 3–4 years of experience in GMP formulation or compounding operations
Bachelor's degree in a science-related discipline or equivalent experience
Working knowledge of formulation/compounding processes and equipment
Strong attention to detail and commitment to quality
Familiarity with cGMP and regulatory requirements
Basic computer proficiency (Microsoft Office and related systems)
Strong communication and teamwork skills
Ability to prioritize tasks and manage multiple responsibilities
Ability to work in a shift-based, 24/7 production environment
Ability to stand or remain stationary for extended periods
Ability to lift up to 30 pounds repeatedly
Ability to wear required personal protective equipment (PPE)
Must meet gowning and cleanroom requirements
Adequate visual acuity and motor skills to operate equipment and handle materials
Must be medically qualified to participate in a respirator program

Responsibilities

Perform formulation and compounding activities according to SOPs, batch records, and GMP requirements
Prepare buffers, media, and other solutions following detailed instructions
Execute key process steps including API dissolution, in-process testing, and final batch preparation (QS)
Support production start-ups, changeovers, and technology transfer activities
Operate manufacturing equipment such as tanks, filtration systems, autoclaves, glass washers, and integrity testing devices
Ensure proper setup, operation, and cleaning of equipment
Troubleshoot routine equipment and process issues, escalating complex concerns as needed
Accurately complete batch records and documentation prior to review
Maintain logbooks and ensure compliance with cGMP, cGLP, and regulatory standards (FDA, 21 CFR 210/211/820)
Initiate and document process deviations, participate in investigations, and support corrective actions
Ensure product quality, safety, and batch integrity at all times
Identify and communicate process improvements and operational efficiencies
Support audit readiness and maintain a high standard of compliance
Work closely with supervisors and team members to meet production schedules
Communicate issues, delays, or opportunities for improvement in a timely manner
Cross-train across functional areas to expand technical capabilities