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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Scientist
Posted: 09/18/2024
2024-09-18
2024-11-02
Employment Type:
Contract
Job Category: Scientific
Job Number: 4010
Job Description
Our client is currently seeking an Analytical Chemist in our Pivotal Attribute Sciences Department in Cambridge, MA. This team plays a crucial role in pivotal phase analytical support, including product development support, testing of drug substances and drug products.
The role will work closely with a team of analysts and scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic small molecule, synthetic peptide and/or antibody peptide conjugates.
The Scientist will integrate and optimally utilize platform and in-depth product attribute knowledge to advance the company products and ensure success through pivotal clinical phases to marketing authorization application.
Responsibilities:
The role will work closely with a team of analysts and scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic small molecule, synthetic peptide and/or antibody peptide conjugates.
The Scientist will integrate and optimally utilize platform and in-depth product attribute knowledge to advance the company products and ensure success through pivotal clinical phases to marketing authorization application.
Responsibilities:
- Regularly perform and adequately document routine maintenance of the HPLC instrument.
- Ensure consumables and supplies are properly maintained and readily available
- Hand-on experience in sample preparation and analysis of synthetic in-process samples, lot release samples, and drug product formulations using primarily chromatographic and spectroscopic techniques.
- Organize and document analytical data under Good Documentation Practice using electronic laboratory notebook system.
- Perform all duties in accordance with established quality protocols and standard operating procedures (SOPs)
- Provide general laboratory support and other responsibilities as assigned by the Supervisor.
- 0+ Years w/ Relevant PhD OR equivalent (where applicable)
- 2+ Years w/ Relevant MS OR equivalent
- 4+ Years w/ Relevant BS OR equivalent
- Advanced and proficient understanding and use of technical principles, theories, and concepts to perform expansive range of work in a role.
- Basic knowledge of related and adjacent disciplinary areas.
- Master’s degree in Analytical Chemistry, Organic Chemistry, Physical, Pharmaceutical, Life Sciences or Engineering
- Hands on experience in chromatographic techniques such as: CEX, SEC and RPLC
- Experience in synthetic peptide and/or peptide antibody conjugates including theoretical knowledge, research, and hands-on experience to support process development/scale up activities and formulation development.
- Experience with operation, maintenance, and troubleshooting of laboratory equipment and instrumentation, especially chromatographic (e.g. liquid chromatography) and spectroscopic instruments (e.g. mass spectrometry).
- Experience in laboratory settings within the pharmaceutical or biotech industry
- Technical aptitude for identification, development, and implementation of novel analytical technologies
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