MS&T Process Scientist
AstraZeneca
Summary
The MS&T Process Scientist plays a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. This position is primarily focused on supporting Clinical (inclusive of Tech Transfer) and Commercial products and/or troubleshooting process and equipment issues arising on the manufacturing floor at Frederick Manufacturing Center (FMC). In addition, lab work may be required to support Tech Transfer deliverables.
Job description
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
Requirements
- Upstream/Downstream Technology Transfer (TT) and/or cell culture/purification process development experience
- Experience in Biologics working in cell culture (mammalian cell lines) 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
- 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
Benefits
- 401(k) Matching
- Paid Vacation
- Paid Holidays
- Paid Leaves
- Medical, Dental & Vision
- Prescription Drug Coverage
- Short-Term Incentive Bonus
- Equity-Based Long-Term Incentive
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.