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 employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

- Medical, dental & vision
- Critical Illness, Accident, and Hospital - 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability
- Health Spending Account (HSA) - Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Rockville,MD.

Final date to receive applications

This position is anticipated to close on Sep 26, 2026.

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