Senior Manufacturing Associate

Company Summary

inSoma Bio, located in Durham, North Carolina, is a clinical-stage regenerative medicine company developing Fractomer™, a recombinant structural protein designed to enable the body to rebuild and restore tissue. Produced through bacterial fermentation and purified using both established and proprietary processes, Fractomer forms a unique injectable scaffold intended to support tissue integration and regeneration.

Our lead program focuses on improving outcomes in autologous fat grafting, a widely used reconstructive procedure where reliability and long-term tissue survival remain significant challenges. Fractomer is designed to provide structural support that improves predictability and durability of these grafts, with potential applications across reconstructive and regenerative medicine.

As inSoma Bio advances its first clinical product toward human studies, we are expanding our Operations team to support manufacturing and process development for this next stage of growth. This is a rare opportunity to work at the intersection of biomanufacturing, translational science, and clinical innovation, helping bring a new class of regenerative biomaterials from the laboratory into the clinic.

The individual in this role will join a small, highly collaborative team responsible for producing Fractomer for preclinical and clinical use, contributing directly to the manufacturing foundation that supports the company’s transition into clinical development.

Job Description

The Senior Manufacturing Associate is responsible for supporting and executing daily manufacturing operations for a recombinant protein product, including both upstream fermentation and downstream purification activities. The Senior Manufacturing Associate will perform work in accordance with established standard operating procedures (SOPs) and batch process records (BPRs) while adhering to Good Manufacturing Practices and Good Documentation Practices.

In addition to manufacturing activities, the Sr. Manufacturing Associate will contribute to the execution of validation protocols, perform analytical testing, support revision and improvement of cGMP documentation, ensure compliance with internal quality systems, and assist in maintaining manufacturing equipment and facilities in an operational state.

The Sr. Manufacturing Associate will play an active role in maintaining reliable manufacturing operations and will contribute to continuous improvement of processes and workflows within a growing manufacturing environment. The ideal candidate will demonstrate a strong quality mindset and work collaboratively as a key member of the operations team.

Job Responsibilities

· Execute and support the setup, operation, and monitoring of small-scale bacterial fermentation processes, including inoculation, fermentation runs, harvest activities, and preparation of required media, buffers, and solutions in accordance with approved SOPs.

· Perform downstream protein purification according to approved SOPs, including homogenization, clarification, chromatography, filtration, and related process activities, and contribute to troubleshooting and optimization of manufacturing workflows.

· Execute final product fill/finish operations, including manual filling of serum vials and lyophilization.

· Operate, maintain, and clean manufacturing equipment in accordance with cGMP standards while ensuring equipment readiness for scheduled production activities.

· Collect, label, and perform analytical testing on in-process and final product samples to evaluate protein concentration, purity, and identity using methods such as SDS-PAGE, UV/Vis spectrophotometry, ELISA, and other protein characterization assays.

· Accurately record analytical and manufacturing data, complete batch production records, equipment logs, and laboratory documentation in compliance with current Good Manufacturing Practices (cGMP), and promptly report abnormal or out-of-specification results.

· Participate in documentation review and revision of SOPs, batch records, and other controlled documents, and support deviation investigations, CAPA activities, and change control processes.

· Maintain a clean, organized, and inspection-ready manufacturing workspace and collaborate with operations and quality personnel to ensure consistent manufacturing performance and regulatory compliance while adapting to evolving operational needs within a dynamic startup environment.

Qualifications

· Bachelor’s Degree (STEM preferred) with 3+ years of relevant experience or a BioWorks Certificate with 5+ years of relevant experience.

· 2+ years experience working in a cGMP environment using Good Documentation Practices.

· Excellent written and verbal communication skills.

· Hands-on laboratory experience with downstream protein purification (experience with upstream fermentation is preferred).

· Experience working with aseptic technique and general laboratory safety.

· Strong organizational skills with the ability to multi-task in a fast-paced environment.

· Computer Skills: Experience with MS Office Suite.

Preferred Qualifications

· Knowledge of 21 CFR 820/ISO 13485

· Experience with Benchling or eQMS system

Working Conditions

· Work is onsite and will be performed in laboratory and biomanufacturing environments.

· Personal Protective Equipment (PPE) is required, including the use of a half respirator during laboratory cleaning.

· Ability to stand for extended periods of time.

· Ability to lift items up to 25 lbs and occasionally move items up to 50 lbs.

• · Occasional shift or weekend work may be required based on the manufacturing schedule.