Scientist, Large Molecule / Drug Substance

We are looking for Scientist, Large Molecule / Drug Substance for our client in Spring House PA.

Job Title: Scientist, Large Molecule / Drug Substance

Job Location: Spring House PA

Job Type: Contract

Job Overview:

Pay Range: $35.00hr - $40.00hr

Requirement/Must Have:

• Ph.D., MS, or BS in Chemistry, Chemical Engineering, Biotechnology, or a related Scientific discipline.
• 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.

Responsibilities:

• Develop, design and perform process development work to support novel biologics purification activities.
• Design and execute experiments in support of upstream and downstream purification development of biologic drugs.
• Propose and develop models that improve the production and purification of selected proteins.
• Contribute to innovation efforts in supporting purification and analysis of proteins and large molecules.
• Contribute to Designs Of Experiments (DOE).
• Participate in a cross-functional team.
• Perform process development studies including determination and characterization of process parameters associated with liquid chromatography, concentration and filtration operations, and viral clearance.
• Apply suitable reduced-laboratory scale models representative of the commercial-scale process.
• Support Process Analytical Technology (PAT) application including active feedback to the processing lines.
• Develop clinical manufacturing process instructions and Process Validation protocols.
• Execute characterization studies relevant to the stage of development.
• Interpret relevant analytical data to drive biologics concentration studies, purification strategies and characterization decisions.
• Handle samples and execute workflows and studies, collect, record, and interpret data appropriately.
• Present data at internal meetings.
• Train and mentor other personnel on techniques and equipment.
• Write technical memos and keep abreast of scientific developments in relevant fields.

Nice to Have:

• Knowledge and experience in protein characterization with a variety of standard analytical methods (Raman, A280, ProG, SEC, NIR, etc.).
• Experience in protein purification.
• Experience in filter sizing including depth, sterile and nano filtration.
• Experience in Resin Lifetime Studies.
• Experience with GMP processes.
• Strong verbal and written communication skills.
• Ability to communicate effectively with stakeholders.

Skills:

• Liquid chromatography.
• AKTA PURE.
• AKTA AVANT.
• Protein purification.
• SP-TFF.
• UF/DF.
• Large molecule drug substance.
• Design of Experiments (DOE).
• Process Analytical Technology (PAT).
• Viral clearance.
• Protein characterization.

Qualification And Education:

• Bachelor s degree or higher in a scientific discipline.

==

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities