Associate Specialist Clinical Biologics

Associate Specialist/Specialist, Clinical Biologics 1st shift

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. 

Summary of the group

As an Associate Specialist/Specialist in the Clinical production team within Biopharmaceutical Development, you’ll build broad knowledge of bioprocessing in a cGMP environment to launch your career in the biopharmaceutical industry. In this role you will take an adaptable, science driven approach to everything you do.  You will become an integral part of process development, accelerating product candidates into the clinic and gaining knowledge and experience in cell culture, purification and critical support activities. Under the supervision of highly trained personnel, you will gain the process knowledge and skillsets to perform large scale clinical development activities.  You will join a collaborative and driven team in an elite biopharmaceutical company.

Main Duties & Responsibilities

Associate Specialist:

Operates bio-pharmaceutical manufacturing equipment such as: incubators, stainless steel and disposable bioreactors, depth filtration skids, chromatography skids, single-use mixers, centrifuges, washers, autoclaves, tanks and in-process testing instruments.

Performs steam sterilization, clean in place, manual cleaning and sanitization of equipment

Records manufacturing activities clearly and accurately within approved current good manufacturing practices (cGMP) documents and regulatory requirements.

Prepares for processing by ensuring equipment and materials necessary are adequate and available.

Ensures a safe and environmentally sustainable work environment in accordance with AstraZeneca standards

Ability to use MS Office tools and AZ enterprise systems

Specialist:

Operates and serves as a trainer for operation of manufacturing equipment such as: incubators, stainless steel and disposable single-use bioreactors, depth filtration skids, chromatography skids, single-use mixers, centrifuges, cleaning/sanitization of equipment, washers, autoclaves, tanks and in-process testing instruments.

Monitors process parameters, contributes to investigations, troubleshoots during processing, and recommends potential solutions.

Serves as the “Subject Matter Authority” in unit operations to improve quality, ensure safety, and drive process efficiency and accuracy

Support process improvement initiatives and authors or revises standard operating procedures accordingly.

Reviews executed Production Records for accuracy and completion

Ability to use MS Office tools and AZ enterprise systems

Education & Experience Requirements:

Associate Specialist: Bachelor's degree and 0-4 years of relevant experience

Specialist: Bachelor's degree and 4+ years of relevant experience

Required Skills

Associate Specialist:

Introductory knowledge of chromatography process operations, depth filtration, column packing, TFF (Tangential Flow Filtration) and basic analytical testing (e.g., Protein concentration, osmolarity, pH etc.)

Ability to work with others in a team environment

Specialist:

Proficient in the operation of a