Associate Specialist, Clinical Biologics

AstraZeneca•Gaithersburg, MD

1d•Onsite

About The Position

The Associate Specialist, Clinical Biologics works on the Manufacturing Sciences team at AstraZeneca’s Gaithersburg, Maryland campus, a fully integrated process scale-up and cGMP biomanufacturing function. The clinical manufacturing team performs bioprocessing operations at pilot plant facilities for novel molecules, producing pre-clinical and early- through late-stage clinical drug products to advance the biologics pipeline. The role contributes to process development and supports the advancement of product candidates into clinical trials, with exposure to cell culture, purification, and critical support activities. The position involves operating biopharmaceutical manufacturing equipment, cleaning and sterilizing equipment, and documenting manufacturing activities under current good manufacturing practices and regulatory requirements. It also requires preparing equipment and materials for processing and maintaining a safe, environmentally sustainable work environment in accordance with AstraZeneca standards. The role is based at the Gaithersburg site; no remote or hybrid arrangement is specified.

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

Demonstrated drive and initiative.
Logic and 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.
Ability to work independently and start tasks without prompting.
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.
Clearly and accurately record manufacturing activities in approved, current cGMP documents and in accordance with regulatory requirements.
Prepare for processing by ensuring required 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

Short-term incentive bonus opportunity.
Eligibility to participate in an equity-based long-term incentive program for salaried roles.
Retirement contribution for hourly roles.
Commission payment eligibility for sales roles.
Qualified retirement program, including a 401(k) plan.
Paid vacation and holidays.
Paid leaves.
Health benefits, including medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.
Gaithersburg site amenities include a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria, and copy center.
Qualifying overtime pay for hourly and salaried non-exempt employees.