The Position
This position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. The successful candidate will support the Analytical development team with the development and implementation of process analytical technology for siRNA therapeutics production and will work in a multidisciplinary team of scientists and engineers. This position reports to AD Management.
Responsibilities
- Develops and validates online/at-line/in-line methodologies to monitor, analyze and control manufacturing processes and performance with various instruments
- Generates, analyses, fuses, mines, and models PAT data
- Performs kinetic modeling on various surfaces
- Drives automation projects to completion
- Performs routine testing independently with analytical instrumentation and works closely with team members to provide accurate analytical results in support of new and on-going projects
- Assists with the implementation and validation of new technologies in a manufacturing environment
- Trains and mentors in process analytical technology and data analysis
- Authors various different documentations (e.g. presentations, posters, publications, SOPs, protocols)
- Utilizes analytical technologies towards fostering the advancement of product development and process understanding
- Participates in the review of research papers, intellectual property, and current literature to propose novel technologies for process improvement
- Maintain laboratory notebook and documentation consistent with GLP and Enterprise expectations
- Communicates with internal and external partners on a routine basis
Requirements:
- Ph.D. in Chemistry (or related field)
- Skills and knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals and related organic molecules
- Able to conduct routine testing with analytical instrumentation (IR, HPLC, UV)
- Expertise with analytical instrumentation, and test methodology (e.g. Raman, IR, NMR)
- Knowledgeable with data acquisition systems, databases, chemometrics and machine learning
- Understanding of theories and principles of analytical chemistry
- An ability and desire to learn and advance existing skills with analytical and plant technologies.
- Proven track record of critical thinking/problem solving
- Self-motivated and strong work ethic
- Attention to detail
- Can independently perform tasks assigned
- Can be flexible with changing priorities
Preferred:
- Experience with chromatography processes and process development is preferred
- Programming, modeling, and automation experience preferred
- Programming and statistical data analysis experience preferred
- Computational modeling experience preferred
The base salary range for this position in the selected city is $100,000 – $140,000 annually.
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