The Scientist is responsible for laboratory facilities and operations at the site. This includes scheduling and prioritization of workload in the chemistry laboratory, including qualification of instrumentation and processes.
Coordinate scheduling and prioritization of activities in the chemistry laboratory. This includes testing of raw materials, utilities, API, and drug products (release and stability). Utilize investigational tools to troubleshoot, identify root cause, and recommend corrective actions. Utilize LEAN tools such as standard work, load leveling, 5S, and value stream mapping.
Interprets and evaluates data in terms of accuracy, precision, trends and potential GMP impact and recommends appropriate corrective action where necessary.
Strong understanding of compendial sources.
Provide chemistry support of systems and processes at the site. Conduct and review non-conformance investigations. Writes evaluations to support change control. Helps troubleshoot and assists in determining appropriate corrective actions. Applies existing techniques and procedures, with recommendations, and implementation of modifications for improved efficiency.
Oversight of laboratory investigations and cleaning validation.
Interface with external partners, senior management, and regulatory agencies to discuss execution of laboratory programs at the site, as well as provide results and trends associated with the programs.
Provide subject matter expertise for standard operating procedures and quality standards content, as well as provide gap analysis to ensure that the programs are compliant with all regulatory requirements.
The primary technologies in this lab are HPLC and dissolution.
Recommends and executes process improvements to continually improve laboratory performance.
High productivity and the ability to multi-task and attention to detail are critical characteristics of this position.
Demonstrates flexibility/agility and engagement in a changing environment.
SHIFT HOURS: 8:00am-4:30pm.
EDUCATION AND EXPERIENCE
BA/BS, or MS in Chemistry, Biochemistry, or related science. BS degree in Chemistry or related science discipline with a minimum of 5 years' experience, or MS degree with a minimum of 3 years' experience.
Related experience in Quality Control, lab work specifically. OR experience in Quality Assurance or related experience is required.
Preferred experience includes HPLC, Dissolution, use of Empower3 software and prior experience with GMP documentation.
Key characteristics of a successful candidate in this position: willingness and ability to learn, ability to work in a team environment, and attention to detail.
Job duties involve occasional lifting (less than 35 lbs).
Candidate must not be Cephalosporin/Penicillin sensitive.
Good oral, written, and interpersonal communication skills are required. Candidate should possess basic computer skills such as data entry, and a high level of attention to detail is also required. The successful candidate will also demonstrate the ability to organize time independently and prioritized their workload to meet objectives in a flexible, team-oriented environment.
Full time
Regular
Colleague
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