Senior Manufacturing Associate

Job Responsibilities:

1. Execute gene therapy manufacturing processes according to established protocols and standard operating procedures (SOPs).
2. Perform cell culture, transfection, purification, and other molecular biology techniques involved in gene therapy production.
3. Operate and maintain equipment such as bioreactors, chromatography systems, and filtration units used in gene therapy manufacturing.
4. Monitor and control critical process parameters to ensure product quality and yield meet specifications.
5. Participate in process troubleshooting and resolution of manufacturing deviations or discrepancies.
6. Contribute to the design and optimization of manufacturing processes to enhance efficiency and scalability.
7. Document manufacturing activities, including batch records, logbooks, and equipment maintenance records, in compliance with regulatory requirements.
8. Collaborate with cross-functional teams, including Quality Assurance, Quality Control, Process Development, and Engineering, to achieve production goals and maintain compliance.
9. Stay current with advances in gene therapy manufacturing technologies and industry best practices.

Qualifications:

1. Bachelor's degree in Biochemistry, Molecular Biology, Biotechnology, or a related field preferred.
2. Minimum of 2-5 years of experience in biopharmaceutical manufacturing, preferably in gene therapy or viral vector production.
3. Hands-on experience with cell culture techniques, viral vector production, and purification processes.
4. Proficiency in operating and troubleshooting bioprocessing equipment such as bioreactors, centrifuges, and chromatography systems.
5. Strong understanding of cGMP regulations and guidelines governing biopharmaceutical manufacturing.
6. Excellent analytical and problem-solving skills, with the ability to troubleshoot process issues and implement solutions.
7. Effective communication skills and the ability to work collaboratively in a cross-functional team environment.
8. Detail-oriented with a focus on accuracy and compliance in documentation and record-keeping.
9. Ability to adapt to a fast-paced and dynamic work environment, with a commitment to continuous learning and improvement.

Contact your Recruiter:

For more information about the role and to express your interest, you can reach out to our recruiter, Zhanri, directly:

• Email: zdesphy@harbasolutions.com
• Phone: 617.284.4255

About Harba Solutions:

Harba Solutions is a leading scientific services firm operating across a range of scientific industries including pharmaceuticals, biotechnology, medical devices, contract research organizations, and agricultural sciences. With a substantial network of qualified scientific candidates and ongoing interactions with emerging talents, we specialize in effectively placing scientific professionals in roles encompassing laboratories, chemistry, biology, and quality-focused disciplines, to name a few. Backed by strategic investors, our core values of commitment, work ethic, team and self-ownership, craft mastery, and pursuit of success shape our mission. Explore the opportunities at Harba Solutions and become part of the evolution of scientific services.