Associate Specialist/Specialist

2 weeks ago

Gaithersburg, United States Workday Full time

Associate

Specialist/Specialist

(Next Generation Manufacturing) 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 place 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.

Summary of the Position: The AstraZeneca Manufacturing Sciences department (within Biopharmaceutical Development) is responsible for the process scale up, technology transfer, and cGMP manufacturing of a very diverse pipeline.

This position will follow an intensified perfusion cell culture and continuous purification process from development (Process Scale-up) to manufacturing. The Next Generation Manufacturing (NGM) position will have firsthand experience operating, transferring, and training to support a cGMP campaign.

The position requires close collaboration with cell culture, purification, engineering, automation, process scale-up and manufacturing to evaluate innovative new technologies and implement the novel processing methods. The environment is fast-paced, ambitious and dynamic, with varying degrees of process definition and frequent piloting of novel process operations and novel molecule formats. This position is a purification focused role.

Main Duties & Responsibilities: Responsibilities include creating solutions to specific process scale-up and cGMP issues relating to continuous processing and integration of controls. The team would develop the methodology to operate a new manufacturing process in a cGMP facility, and they would also be responsible for creating the documentation and providing the training for manufacturing. This includes understanding and transferring control strategies, process troubleshooting, operational adjustments, and evaluation of data from multiple scales.

This role will require you to present at internal departmental and cross-functional meetings. This is a hands-on, laboratory/pilot plant position that requires good laboratory skills, attention to detail, and the ability to create and follow standard procedures

Operates and trains on manufacturing equipment such as: depth filtration skids, chromatography skids, chromatography columns

Ability to investigate/troubleshoot operational issues and communicate those clearly to a broad audience

Makes detailed observations, analyzes data, and interprets the results. Utilize literature searches and reviews to understand industry-wide initiatives

Technology transfer of the process by assisting with process descriptions, SOPs, and batch records

Good organization and interpersonal skills with the ability to interact effectively with project teams, manufacturing personnel, development and suppliers

Education & Experience Requirements: Education:

Bachelor’s or Master’s degree in Biology, Biochemistry, Bioprocess Engineering, Chemical Engineering, or related life sciences field.

Experience: Associate Specialist:

Bachelor’s degree with 0-4 years or Master’s degree with 0-2 years of related experience in industry or academia. Specialist:

Bachelor’s degree with 4+ years or Master’s with 2+ years of related experience in industry or academia.

Required Skills: Experience operating purification equipment, understanding of chromatography control systems, offline analytics, and must have excellent aseptic technique

Familiarity with root cause analysis and problem-solving tools

Proficient with Excel, Word, PowerPoint, and data analysis

Ability to adapt to change quickly and work in a cross-functional team

Ability to train and advise coworkers on all aspects of the NGM process

Position requires periodic weekend work

Desired Skills: Knowledge of engineering principles associated with large-scale production of biotherapeutics

Knowledge of GMP manufacturing principles and operations in a compliance-controlled environment

Skilled in effectively explaining complex scientific or engineering concepts to a broader, diverse, cross-functional audience of scientists, engineers, and senior management

Demonstrate flexibility and willingness to change ways of working

Dynamic individual with the ability to communicate and engage others

Logic and decision-making abilities, critical thinking and troubleshooting skills

Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next? Are you ready to bring new ideas and fresh thinking to the table? Brilliant We have one seat available, and we hope it's yours.

Date Posted 06-May-2024 Closing Date Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law. #J-18808-Ljbffr

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