MS&T Process Scientist Full-time NEW

MS&T Process Scientist

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50' Business in Frederick and awarded Frederick County's 'Best Place to Work'. This distinctive biologic manufacturing facility, with over 800 employees, plays a direct role in treating patients with cancer, respiratory diseases, and autoimmune conditions globally.

At FMC, we are committed to delivering life-changing medicines while also creating a workplace where people feel valued and connected. From catered site events and friendly competitions to community outreach, environmental and wellness programs, and team-building activities, we make time to celebrate achievements and recognize the diversity of our workforce. We are dedicated to fostering a culture of inclusion, collaboration, and continuous learning through ongoing skill development and training opportunities for our employees.

Driven by our ambition to accelerate growth, improve patients' lives, and shape the future of AstraZeneca Operations, there has never been a more exciting time to join our team.

What You'll Do:

You will be responsible for leading or participating in molecule support activities such as the following:

• Lead Technology Transfer & Production support activities including: fit-to-plant, process risk analysis, timely generation of Chemistry Manufacturing and Controls documentation, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, and investigation support.
• Serve as Drug Substance process Workstream Lead and/or general Technical Lead for both clinical and commercial projects at FMC.
• Serves as mentor and positive role model to colleagues with occasional supervision of entry-level scientists or associates.
• Broad understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to TT
• Make detailed observations, analyze data using multivariate analysis (MVDA) software, and interpret results. Likewise, effectively present results at internal meetings and external scientific meetings.
• Author/review technical reports and deliver presentations utilizing sound scientific reasoning and interpretation of the available data.
• Provide solutions to a variety of problems of diverse scope involving basic scientific principles.
• Collaborate with internal and external stakeholders including but not limited to Manufacturing, Quality and Process Development

Essential for the Role:

• Upstream/Downstream Technology Transfer (TT) and/or cell culture/purification process development experience.
• Experience in Biologics working in cell culture (cell lines such as mammalian) or purification of large molecules in therapeutic antibodies and/or vaccines.
• Fundamental understanding of Upstream/Downstream unit operations such as cell culture scale up, harvest, affinity and ion exchange chromatography, low pH viral inactivation, virus filtration, and UF/DF.
• Understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to Technology Transfers.
• Knowledge of GMP manufacturing principles and documentation.
• Ability to apply critical thinking to solve problems, work independently and support/lead complex investigations.
• Strong interpersonal and communication skills.

Education and Experience Requirements

• BS/BA/MS/PhD in Engineering, Biological/Physical Sciences, or equivalent focus of study.
• BS 7+ years, MS 3+, PhD 2+ years in a cGMP biopharmaceutical production or process development setting with a focus in biologics

The annual base pay for this position ranges from $ 112,304 – $168,456 depending on level. 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.