Associate Specialist / Specialist- Clinical Biologics (2nd 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 innovative 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 crafting a culture of inclusion and collaboration.

The Gaithersburg manufacturing facility is a GMP site that manufactures clinical drug substances for human use. Gowning requirements will be strictly followed and make-up, artificial nails, and jewelry are not permitted to be worn while working.

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 all area specific production equipment such as column chromatography operations, tangential flow filtration, formulation and column packing
• Proficient in basic analytical testing (e.g., protein concentration, osmolarity, pH etc.)
• Ability to work with others in a team environment and lead a team o