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Actalent QC Stability Coordinator in Medford, Massachusetts

Description:

The client is looking for a high-performing, self-motivated individual who works well in a fast-paced environment in a leading-edge biotech company. The company is looking for a key individual to play a pivotal role in advancing breakthrough therapies to rapidly address emerging pathogens. Reporting directly to the QC Laboratory Sr. Manager, the individual will be a key contributing member of our Life Science Team. The position will assist in establishing and running a cGMP compliant stability program providing support to the advancement of mRNA based human vaccines and other RNA based therapeutics. Key Position Responsibilities:

This position will be responsible for overseeing the cGMP stability program. Responsibilities include, author stability protocols, reports, data trending, maintenance of data table to support regulatory submissions and shelf-life activities.

As product development occurs, the QC Stability Coordinator will be responsible for the following activities:

• Management of stability samples, including receipt, study initiation, storage, and sample pulls.

• Ensure all testing occurs within the testing window.

• Ensure timely review of associated data including data reconciliation / trending.

• Timely review and communication of stability data including leading the stability meeting.

• Author stability protocols and reports.

• Initiate laboratory deviations and support investigations (OOS), performing assessment, authoring protocols/reports and investigation closure.

• Participate in providing the necessary information for regulatory filings and inspections.

• Participate in audits (internal and external) and in remedial actions for any non-compliance.

• Other duties as needed.

• Collaborates with internal and external stakeholders and partners to ensure that regulatory agency quality assurance requirements are met. May assist with auditing Contract Research Organizations as well as assist with hosting regulatory agency (e.g., FDA) inspections.

Skills:

chemistry, biologics, JMP, stability protocols, sample coordination

Additional Skills & Qualifications:

Position Requirements

• Bachelor’s degree with 2 – 4 years in a biotechnology discipline or MS 1 – 2+ years.

• 1 - 2 years of experience in a cGMP/GxP environment is preferred.

• Previous experience with stability studies and JMP software.

• Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude.

• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.

• Knowledge of applicable GMP regulations, ICH & FDA guidelines, USP, and other applicable regulatory guidances (US and EU).

• Ability to succeed in a team-oriented environment under very dynamic conditions. Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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