Education and Experience:
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Bachelor’s degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
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ARS: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+years’)
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OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years’)
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OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years’)
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
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Excellent verbal and written communication skills are essential
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Experience and/or working knowledge of control strategy development.
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Good understanding of cGMP, ICH, FDA, and USP guidelines, including ICH guidelines on the control of impurities (organic, residual solvents, and elemental, DNA reactive (including ICH M7 option 4 / in silico control), and nitrosamines)
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Skilled in modern analyses for small molecule pharmaceuticals, particularly chromatography (HPLC/UPLC), KF, qNMR etc.
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The ability to work successfully in both a team/matrix environment as well as independently
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The ability to work in a fast-paced environment, manage priorities, communicate outcomes and maintain timelines for multiple projects
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.