Scientist-3

Job title: Scientist-3

Location: Florence, SC

Duration: 12 months on W2 High possibilities of extension (Temp to hire)

Shift: Mon-Friday, day shift (8-5).

Job Description:

Summary:

· The Scientist 3 develops, investigates, creates, transfers, and validates new scientific methodologies used to analyze raw materials, production intermediates, and final products.

· Conducts laboratory work as necessary to assure that products are tested per operating procedures. Ensure that work is carried out in an efficient and safe manner.

· Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results internally and externally to clients.

· May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development. Works on significant technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations.

· Participates in technical discussions with clients. Contributes to the design of methods and supports problem solving as necessary with leadership and independent judgment. Makes decisions that frequently require developing new options to solve problems.

Key Responsibilities:

· Develop feasible QC-friendly analytical methods for drug intermediates and APIs that meet or exceed the quality requirements from clients.

· Collect reliable data through designed laboratory experiments with accurate, detailed documentation for evaluation, development and troubleshooting.

· Record and analyze scientific data/observations in detail. Summarize and interpret data to draw logical conclusions.

· Write technical updates/reports. Participate in technical discussions with internal teams and clients.

· Analytical knowledge across many techniques is required including at least NMR, IR, KF, HPLC, GC, and MS.

· Draft, review Methods, Protocol, Reports, Deviations, Change Controls, and Investigative documentation.

· Execute procedures under SOP/cGMP guidelines.

· Evaluate technical package and successfully lead analytical technology transfer.

· Provide timely technical support for Process R&D, Quality Control and other inter-departmental needs.

· Lead projects with minimal supervision; may lead projects, including but not limited to managing process development timelines and deliverables, coordinating analytical development activities.

· Fit in a multidisciplinary team with flexibility to carry out fast-turnaround projects.

· Maintains a clean and safe work environment including work area, instrumentation, and testing materials.

· Understands and works in compliance with all cGMP, OSHA, and safety regulations, BOPs and SOPs.

· Executes cGMP procedures, lab procedures, BOPs and SOPs.

· Executes developmental and validated test methods using HPLC, GC, spectroscopy, GC/MS, LC/MS, and/or traditional wet chemical testing, and trains other employees on these techniques.

· Provides thoughtful technical review of data collected by other employees.

· Investigates out-of-specification or unexpected results and non-routine analytical and product problems.

· Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems.

· Ability to drive functional, technical and operational excellence. Ability to inspire and drive team effectiveness.

· Good knowledge of medical terminology, clinical data, and Good Manufacturing Practices (GMP). Strong proficiency in

· Microsoft Office Suite (Word, Excel, and PowerPoint. Effective written, interpersonal, and presentation skills. Ability to work on multiple projects simultaneously.

Qualifications:

· Master’s degree in chemistry or related field required, or equivalent experience.

· 10-15 years of experience working in a laboratory preferred, (GLP or GMP/cGMP environment preferred)

· 10-15 years of experience working with analytical instrumentation, such as HPLC, GC, and MS.

· Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

· Extensive knowledge and understanding of chemistry and analytical instrumental technologies.

· Extensive knowledge of qualitative and quantitative chemical analysis.

· Extensive knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.

· Good problem solving skills and logical approach to solving scientific problems.

· Proficiency with HPLC, GC, LC/MS. Good interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees.

· Ability to read, analyze, and interpret technical procedures and governmental regulations.

· Ability to write standard operating procedures, simple protocols, and reports.

· Ability to respond to common inquiries or complaints from customers or regulatory agencies.

· Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.

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Job Type: Contract

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In person