Manufacturing Associate
3 weeks ago
Title: Downstream & Purification Scientist/Engineer
Location: Rensselaer, NY 12144
Duration: 6 months (contract to hire)
Top 3/Specific Skills: Nothing too specific, generally people with familiar with wet lab and good gXP standards , familiarity with general technologies, chromatography, IT systems (word, excel or JUMP), keeping an eye out on cultural fit.
Lab focused team – supporting manufacturing. Support through investigations, characteristics, raw material assessment, specifically focused on downstream purification, microbiology.
Entry level is fine, regionally they have a tough time getting talent coming out to area. Tend to have the most success looking for talented newcomers. Entry level – at least bachelors in science or related engineering fields.
Team work/transparency. Everything is team based and tasks will be specific to the person.
Company culture- idea of GXP, lab environment but very close to manufacturing GMP, GLP, GDP
Responding to updating information and challenges as they present through manufacturing. Ability to be flexible and deal with ambiguity.
Summary: Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. Process Characterization and Technology Scientists provide characterization of manufacturing operations and/or technology through prospectively defined laboratory experiments. Process Characterization and Technology Engineers may support all phases of projects from research and feasibility studies through implementation into commercial manufacturing processes.
Essential Duties and Responsibilities may include, but are not limited to, the following:
- Plan and execute experiments to generate data to increase process and material understanding, design control strategies, or determine root cause and impact of process non-conformities.
- Analyze information and data from multiple sources to build conclusions related to process capability and understanding.
- Author protocols, reports, and/or other technical documents with conclusions based on available process and product knowledge.
- Ensure alignment of SOPs, Policies, and other internal documentation with industry and regulatory expectations such as ICH guidelines.
- Maintain and improve labs, lab processes, and equipment.
- Work effectively and efficiently in a team-oriented environment. Expected to interact and collaborate cross-departmentally.
- Apply principles of biology, chemistry and other scientific fields to the development and execution of process characterization and investigation studies.
- Analyze data using a combination of statistics, scientific principles and other techniques to gain insights into manufacturing process performance and control.
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