Process Development Scientist Microbiology

Job Title:

Process Development Scientist - Microbiology

Job Description

This role involves optimizing bioprocesses for the production of biologics, including cell culture, fermentation, purification, and lyophilization processes. The ideal candidate will have hands-on experience in biotech manufacturing, a solid understanding of bioprocess engineering, and a commitment to maintaining high-quality standards. Experience working under GMP is preferred. Additionally, the candidate will support process development in executing production processes for new synthetic biology-based cellular medicines, including process scale-up and in-process analytical tests.

Responsibilities

+ Operate and monitor upstream bioprocess equipment, independently setting up and executing bioreactors, scale-up fermentation, concentration, drying, and associated systems.

+ Perform cell culture, media preparation, and fermentation processes as per standard operating procedures (SOPs).

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

+ Maintain accurate and detailed records of all manufacturing activities, including batch records, process parameters, and deviations.

+ Ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal quality standards.

+ Work closely with cross-functional teams, including Quality Assurance, Quality Control, and R&D, to ensure seamless integration and execution of manufacturing processes.

+ Communicate process changes, updates, and issues effectively to stakeholders.

+ Present data at internal meetings, collaborate with research groups, and author scientific reports for internal documentation, as required.

+ Participate in process improvement initiatives and contribute to the development of new technologies and methodologies.

+ Stay current with industry trends and advancements to enhance manufacturing practices.

Essential Skills

+ Fermentation, including bacterial and yeast fermentation.

+

Experience with bioreactors and process development in both upstream and downstream processes.

+ Understanding of microbiology, monoclonal antibody purification testing, and lyophilization.

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

+ Excellent problem-solving skills and attention to detail.

+ Proficiency in using process control systems and laboratory equipment.

+ Strong organizational and communication skills.

Additional

Skills & Qualifications

+ PhD or MS in Biotechnology, Biochemistry, Microbiology, Chemical Engineering, or a related field.

+ Minimum of 1-2 years of experience in upstream biomanufacturing, including hands-on experience with cell culture and fermentation processes.

+ Ability to work in a fast-paced, dynamic environment.

Work Environment

The position is based in a lab environment within a small-scale manufacturing setting. The team is collaborative, supporting initiatives to develop treatments for immunity and cancer, utilizing new technology for delivering medicine in a more patient-friendly manner. The company boasts ongoing clinical trials with no drug-related adverse events, offering a chance to contribute to the development of novel immunotherapies that can transform patient lives.

Job Type & Location

This is a Contract to Hire position based out of Rockville, MD.

Pay and Benefits

The pay range for this position is $43.27 - $57.69/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of…