MSAT Scientist, Purification

The MSATScientist(Purification) willbe a key member of the new MSAT Labs at College Park

You will work on the following areas

• Plan, design and execute small-scale Purification studies using qualified small-scale models to support commercial manufacturing. 

• Lead and execute technology transfer and model qualification of lab models transferred from Process Development to MSAT Labs.

• Assess new technology and advancements to gain better understanding of our products and processes 

Responsibilities

• Design and perform studies to support the robustness,process optimization, and characterization of the manufacturing processes, while assessing continual improvements, new material and technology introductions, feasibility assessments that support yield/process improvement initiatives and cost of goods improvement projects that can be replicated robustly at commercial scale, in line with regulatory and commercialmanufacturing requirements, including industry best practices.

• Support large-scale manufacturing scale-up activities and New Product Introductions including leading, designing and executing studies such as dropout studies from large scale engineering and technical batches, increasing process knowledge, providing recommendations, and problem solving toincrease probabilities of technical success, while minimising technical risks.

• Provide technical expertise and troubleshooting for manufacturing processes. Design and execute experiments which support process investigations, and resolution of Purification process deviations, root cause analysis, and CAPAs to support commercial operations, and studies in support of regulatory changes.

• The candidate must possess critical thinking skills, being entrepreneurial, with an ability to integrate data and information to solve complex problems to maintain robust and improved manufacturing processes.  Effectively communicate complex ideas to audiences with varying degrees of knowledge

• Collaborate cross-functionally to align on study goals, timelines, and project. planning to ensure efficient and strategic execution of MSAT Lab activities.

• Apply statistical tools such as Design of Experiments (DOE) using software such as jmp to drive robust experiments and data-driven technical assessments.

• Analyse complex datasets, interpret results, and prepare detailed technical reports and presentations to cross-functional teams.

• Maintain knowledge and history of the products and process throughout the entire commercial lifecycle, inclusive of development history.

• May be required to present/defend technical and scientific approaches in both written and verbal form, including during regulatory agency inspections or information requests.

• Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations.

• May be required to work periodically out of normal business hours or participate in weekend rota to support ongoing lab studies. 

You will need to have:

• A degree in Life sciences or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering:

• PhD preferred or M.Sc with >3 years of experience

• Extensive technical knowledge of protein purification/filtration in either research or biopharmaceutical manufacturing roles in Technical, R&D, or Process Development/Optimisation.

• Deep technical understanding of column chromatography, sub-micron filtration, UF/DF, buffer/solution preparationand associated systems.

• Working knowledge of cGMP requirements and implement best practices to ensure technical excellence.

• You will use your technical proficiency, scientific creativity, and collaboration with others, using independent thought, working on problems in which analysis of situation or data requires a review of identifiable factors.

• You may present/defend technical and scientific approaches in both written and verbal form,including during regulatory agency inspections.

• Ability to work in a complex, dynamic, global environment, thinking strategically and balancing both long and short-term priorities.

• Strong technical writing skills and statistical analysis.

• Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.

• Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.

• Ability to commit to results independently and adapt to rapidly changing priorities.

• Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external to Alexion.

• Excellent organizational skills with strategic thinking and vision for the group.

• Self-driven, able to prioritize, and to orchestrate multiple activities at once.

• Consistently demonstrate sound business judgment when making decisions.

• Ability to deal with ambiguity and changing priorities.

• Ability to travel up to 10%.

• The duties of this role are generally conducted in a lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry items in accordance with manual handling principles; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.