R&D Scientist I
GENERAL SUMMARY OF POSITION:
The R&D Scientist I is responsible to design and implement purification process development activities, optimize purification process and define process parameters, limits and ranges. The Scientist I is also responsible to implement strategies for optimizing liquid MAb formulation. The Scientist I provides technical guidance and leadership to process development staff.
- Designs,optimizes and characterizes MAb purification processes. Defines purification procedures and operation specifications. Utilizes techniques such as protein A affinity, ion exchange and HIC chromatography and other appropriate unit processes.
- Supports product discovery, upstream process development and other groups within the organization as necessary.
- Implement MAb formulation development, using state-of-art biophysical techniques, such as DLS and DSC.
- Ensures that all work is properly documented and suitable for regulatory submission.
- Drafts technical reports to support technology transfer, regulatory and intellectual property submissions.
- Maintains substantial knowledge of state-of-the-art principles in antibody purification, formulation and validation.
- May manage process development projects and supervise junior process development personnel
- Works on problems of moderate scope where analysis of situation or data requires a review of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solution. Normally receives general instructions on routine work, detailed instructions on new assignments.
- Perform additional job related duties as required.
- Requires a PhD in a relevant scientific discipline such as Chemical Engineering, Biochemistry, Molecular Biology, or other relevant field and 0-2 years of relevant experience in protein purification and characterization.
- Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts.
- Must be detailed orientated with the ability to maintain accurate records and excellent proofreading skills.
- Must have excellent time management and organizational skills, to meet deadlines with minimal supervision.
- Experience with typical column and membrane chromatography, such as affinity, anion/cation exchange, hydrophobic interaction, and/or mixed mode is required
- Experience with FPLC system such as AKTA or Duo-flow is preferred Knowledgeable in the principles of biochemical and biophysical analytical techniques such as SDS-PAGE, HPLC, western blotting, IEF, ELISA, differential scanning calorimetry (DSC), and dynamic light scattering (DLS) is preferred.
- Occasional travel is required.
- Willingness to work extended and, at times unusual hours to meet business needs.