Senior Scientist

4 weeks ago

Gaithersburg, United States AstraZeneca Full time

Senior Scientist (Upstream Tech Transfer)

Introduction to role:

Join us in the Cell Culture and Fermentation Sciences (CCFS) department within Biopharmaceutical Development (BPD). As a Senior Scientist, you will lead process transfer by working directly with process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale-up and transfer of clinical and commercial upstream processes to GMP manufacturing production. Be comfortable with uncertainty and ambiguity, work with lots of unknowns where change is the only constant. We thrive in this environment of pace and ambiguity, taking calculated risks and getting it done. It takes resilience, and for us it makes it even more rewarding when we get a new medicine to our patients.

Main Duties & Responsibilities:

  • Transfer multiple projects as upstream cell culture tech transfer project lead/ representative. Serve as upstream process subject matter expert (SME) to perform fit-to-plant, process risk analysis, timely generation of cell culture process tech transfer documentation, batch record review/approval, technical collaboration with receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, campaign summary report authoring, and routine presentations to cross-functional teams and the management

  • Build and maintain effective working relationships with internal stakeholder groups and potentially external CMOs to successfully advance AZ's Biologics portfolio. Proactively addresses risks/issues to avoid non-conformances and enable efficient transfers

  • Serve as SME and provide technical support to manufacturing within AZ and external partners

  • Support building the tech transfer roadmaps for accelerated development timelines, and novel biologic modalities.

  • Effectively communicate and collaborate in a matrix team setting to implement technical solutions

  • Author, review, and approve technical documents, CMC sections of regulatory submissions (INDs/BLAs), and responses to questions from health authorities.

  • Contribute to the improvement of the tech transfer business processes through idea generation and implementation activities

  • Position requires periodic weekend work and/or occasionally late-night calls (manufacturing support or international collaborations). Position might require some travel to CMOs or other AZ sites (domestic and international).

Education & Experience Requirements:

Education: BS, MS, or PhD in an engineering or scientific field such as biological sciences. A focus in a process engineering field (e.g., chemical, or biochemical engineering) is preferred but not required.

Experience: BS degree and 7+, MS and 5+, or a PhD and 0+ years of relevant industry or research-related experience is required

Essential Skills/Experience:

  • Knowledge and experience of cell culture process development including fed-batch or perfusion processes, platform development, process scale-up, and manufacture.

  • Demonstrated experience in transferring cell culture processes to the GLP or GMP manufacturing facilities.

  • Hands-on experience with bioreactors (bench, pilot, or production scales).

  • Fundamental understanding of upstream cell culture unit operations and scale-up/scale-down principles for the manufacture of biopharmaceutical products.

  • Experience and knowledge of GMP manufacturing principles and documentation.

  • Ability to identify and solve complex bioprocess and manufacturing technical problems in a timely manner.

  • Ability to defend or propose a technical decision.

  • Experience with data and statistical analysis.

Desirable Skills/Experience:

  • Experience with cell culture harvest operation including primary clarification via continuous centrifuge, or direct depth filtration.

  • Experience working in a cGMP-regulated environment and/or large-scale bioprocessing laboratory/facilities.

  • Skilled in conducting process transfer/process development/technology development projects.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you will play an essential role in helping patients who need it the most. There is no better place to apply your Biometrics expertise in a new and different way. With a restless need to keep improving, we are always moving forward and searching for something new. Our supportive, yet challenging, approach makes for an inspiring learning environment. Every setback is seen as a chance to improve, every critique pushes us towards the next ground-breaking solution.

Are you ready to make a profound impact with research that makes a clear and tangible difference? Apply now and join us in our mission to create life-changing medicines

The annual base pay (or hourly rate of compensation) for this position ranges from $107,244 to $160,867. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

21-Oct-2024

Closing Date

25-Oct-2024Our 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.PDN-9d4daa53-13c5-4a7a-84aa-ab8f739a9f17

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