Please note that this position is 100% ONSITE in Spring House, PA.
JOB DESCRIPTION:
TOP SKILLS:
- Role is ONSITE 100% in Spring House, PA
- This role is a Large Molecule/Drug Substance role
- Bachelors degree is required
- Large Molecule knowledge and processing is required (antibodies)
- Exp with biologics solution concentration (SP-TFF and UF/DF)
- Will be preparing solutions
- Liquid chromatography is required (AKTA PURE or AVANT)
- Must have filtration exp
- Must have sample submission exp
- Documentation is required
QUALIFICATIONS:
• 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
DESCRIPTION:
The successful candidate will develop, design and perform process development work to support novel 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 participate in a cross-functional team.
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.
Preferred Skills & Experience:
• 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
Candidates must provide their phone number. Job reference number is A5522.
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