Associate Specialist, Clinical Biologics

AstraZeneca • Gaithersburg, MD

2d • $65,082 - $97,622 • Onsite

About The Position

The Associate Specialist, Clinical Biologics joins AstraZeneca’s Manufacturing Sciences team at its Gaithersburg, Maryland site. The team performs process scale-up and cGMP biomanufacturing in Pilot Plant Facilities, producing pre-clinical and clinical drug products that support the biologics pipeline. This role contributes to process development and helps advance product candidates into the clinic, with exposure to cell culture, purification, and critical support activities.

The position operates and supports biopharmaceutical manufacturing equipment and performs equipment sterilization, cleaning, and sanitization. It also involves preparing for processing, maintaining accurate cGMP manufacturing records, and supporting a safe and environmentally sustainable work environment. The role requires a bachelor’s degree in a science field and 0–4 years of experience.

Requirements

• Bachelor’s degree in a science field.
• 0–4 years of experience.
• Introductory knowledge of cell culture operations, including biosafety cabinet operation, bioreactor operations, aseptic technique, and harvest.
• Introductory knowledge of chromatography, filtration, and basic analytical testing, such as protein concentration, osmolarity, and pH.
• Familiarity with basic biology and chemistry concepts.
• Introductory knowledge of raw material weigh-out and media/buffer preparation.
• Ability to work with others in a team environment.

Nice To Haves

• Demonstrates a high level of drive and initiative.
• Logic, decision-making abilities, critical thinking, and troubleshooting skills.
• Flexibility and willingness to change ways of working and identify opportunities to improve processes in a cGMP clinical manufacturing environment.
• Independent and self-starting, with the ability to work with minimal supervision.

Responsibilities

• Operate biopharmaceutical manufacturing equipment, including incubators, stainless steel and disposable bioreactors, depth filtration skids, chromatography skids, single-use mixers, centrifuges, washers, autoclaves, tanks, and in-process testing instruments.
• Perform steam sterilization, clean-in-place procedures, manual cleaning, and equipment sanitization.
• Accurately record manufacturing activities in approved current good manufacturing practice (cGMP) documents and in accordance with regulatory requirements.
• Prepare for processing by ensuring necessary equipment and materials are adequate and available.
• Help ensure a safe and environmentally sustainable work environment in accordance with AstraZeneca standards.
• Use MS Office tools and AstraZeneca enterprise systems.

Benefits

• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage.
• Short-term incentive bonus opportunity.
• Eligibility to participate in the equity-based long-term incentive program for salaried roles.
• Retirement contribution for hourly roles.
• Commission payment eligibility for sales roles.
• Gaithersburg site amenities include a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria, and copy center.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level