Scientist II

Job Description

Job Summary:

• The successful candidate will work in the Manufacturing Science and Technology (MSAT) department of Client Supply Chain (Client-MTO) Division.
• The incumbent will develop, design and perform process development work to support Client biologics purification activities.
• The incumbent will design and execute experiments in support of upstream and downstream purification development of biologic drugs.
• They will propose and develop models that improve the production and purification of selected proteins.
• They will actively contribute to innovation efforts (e.g. new technologies) in supporting purification and analysis of proteins and large molecules.
• They will contribute to Designs Of Experiments (DOE). They will participate in a cross-functional team.

Duties and Responsibilities:

• Process development studies will include determination and characterization of process parameters associated with liquid chromatography, concentration and filtration operations, and viral clearance.
• Application of suitable reduced-laboratory scale models representative of the commercial-scale process will be a key activity in this role.
• The candidate will successfully support Process Analytical Technology (PAT) application including active feedback to the processing lines.
• These will become the basis for clinical manufacturing process instructions and Process Validation.
• Experimental studies (around 90%) will include a variety of characterization studies relevant to the stage of development.
• The ideal candidate will be able to interpret relevant analytical data to drive biologics concentration studies, purification strategies and characterization decisions.
• The successful candidate will handle samples and execute workflows and studies, collect, record, and interpret data appropriately.
• Data will be presented at internal meetings.
• The candidate will be capable of training and mentoring other personnel on techniques and equipment.
• They will write technical memos with minimal review and keep abreast of scientific developments in relevant fields.
• New concepts and technologies learned in this way will be introduced into the workflow.

Requirements:

• Ph.D. / MS / BS in Chemistry or Chemical Engineering or Biotechnology or a related Scientific discipline with at least 1 / 2 / 4 years respectively of relevant experience is required.
• Experience in liquid chromatography (such as Protein A, CEX, AEX) on AKTA PURE or AVANT system is required.
• Experience with large molecule drug substance manufacturing process is required.
• Knowledge and experience in biologics solution concentration (such as SP-TFF and UF/DF) is required.

Preferred:

• Knowledge and experience in protein characterization with a variety of standard analytical methods (Raman, A280, ProG, SEC, NIR, etc.) is preferred.
• Experience in protein purification is preferred.
• Experience in filter sizing including depth, sterile and nano filtration is preferred.
• Experience in Resin Lifetime Studies is preferred.
• Experience with GMP processes is preferred.
• Communication skills: report writing, oral presentations.
• Team player: working in cross-functional teams.