Manufacturing Associate

Job Description:

We are seeking a motivated and detail-oriented professional to join our team in optimizing bioprocesses for biologics manufacturing, including cell culture, fermentation, purification, and lyophilization. The ideal candidate will bring hands-on biotech manufacturing experience, strong bioprocess engineering knowledge, and a commitment to quality and compliance. GMP experience is highly preferred.

In addition to manufacturing operations, the candidate will contribute to process development for synthetic biology-based cellular medicines, support scale-up activities, and perform in-process analytical testing (e.g., flow cytometry and colony-forming unit [CFU] assays).

Key Responsibilities

Process Operation & Optimization:

· Operate and monitor upstream bioprocess equipment, including setup and execution of bioreactors, fermentation, concentration, drying, and related systems.

· Perform cell culture, media preparation, and fermentation following established SOPs.

· Optimize process parameters to maximize yield, productivity, and product quality.

Documentation & Compliance:

· Maintain accurate and complete records of manufacturing activities, including batch records, process data, and deviations.

· Ensure strict compliance with GMP, regulatory guidelines, and internal quality standards.

Collaboration & Communication:

· Partner with Quality Assurance, Quality Control, and R&D teams to ensure smooth execution of manufacturing and development processes.

· Effectively communicate process changes, updates, and issues to stakeholders.

· Present data at internal meetings, collaborate with research teams, and prepare technical reports as needed.

Continuous Improvement:

· Drive process improvement initiatives and support the implementation of new technologies.

· Stay current with industry trends to enhance bioprocessing practices.

Qualifications

Education:

· Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, or related discipline.

Experience:

· 1–2 years of hands-on experience in upstream biomanufacturing, including cell culture and fermentation.

· GMP manufacturing experience strongly preferred.

Skills:

· Strong understanding of bioprocess principles, equipment operation, and troubleshooting.

· Proficiency with process control systems and laboratory equipment.

· Excellent problem-solving ability, attention to detail, and organizational skills.

· Strong written and verbal communication skills.

Other Requirements:

· Ability to thrive in a fast-paced, dynamic environment.

Job Type: Contract

Benefits:

· 401(k) matching

· Dental insurance

· Flexible spending account

· Health insurance

· Paid time off

· Vision insurance

Work Location: In person

Please email your CV or resume to: This email address is being protected from spambots. You need JavaScript enabled to view it.

About Rise Therapeutics

Rise Therapeutics is an emerging, privately held company located in Rockville, Maryland , which leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. Our drug development focus is driven by new microbiome-related discoveries enabling development of targeted, first-in-class immune modulatory drugs for the treatment of inflammation, autoimmunity, cancer, and infection. In the context of its expertise in synthetic biology medicine, proprietary TPX oral drug delivery platform, and clinical GMP manufacturing capabilities, Rise is creating and rapidly advancing life-changing cellular-based medicines to the market. For more information, go to www.risetherapeutics.com.