Scientist II - Analytical R&D

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

Job Description

How will you make an impact?

The Scientist II 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. Uses judgment in making adaptation and modifications on all assignments. Provides routine and non-routine analyses in an analytical chemistry laboratory following standard practices. Performs analytical methods as assigned for testing on raw materials, samples, stability, production intermediates, and active pharmaceutical ingredients, including method development and qualification activities. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results internally and externally to clients.

Location: Florence, SC

Hours: Mon-Fri 8am-5pm (must be flexible)

Key Responsibilities:

• Consistently aligns with housekeeping standards.
• 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.
• Performs cGMP procedures, lab procedures, BOPs and SOPs.
• Performs daily instrument calibrations / verifications as required.
• Responsible for weekly/monthly inspection of safety equipment.
• Assembles and operates laboratory (bench scale) equipment and carries out experiments independently.
• Conducts routine and non-routine chemical testing and method development/qualification for pharmaceutical raw materials, in-process samples, and active pharmaceutical ingredient samples by internally developed and compendial test methods.
• Performs 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.
• Recognizes and reports/investigates out-of-specification or unexpected results and non-routine analytical and product problems.
• Clearly and accurately communicates the results of work by documenting the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
• Writes and reviews Analytical Methods, validation protocols, validation reports, and SOPs if needed.
• Solves problems related to the processing of chemical procedures.
• 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.
• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

How will you get here?

*Must be able to pass a comprehensive background check to include drug screening.

Education

• Bachelor’s degree in chemistry or related field required.

Experience

• 5+ years of experience working in a laboratory preferred, (GLP or GMP/cGMP environment preferred)
• 5+ years of experience working with analytical instrumentation, such as HPLC, GC, CE, ICP and dissolution apparatus preferred

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

Knowledge, Skills, Abilities

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. …