Job Description

Job Title: Scientist 1/Process Development

Summary:

The Scientist I conducts laboratory work as vital to assure that products are prepared as instructed by their manager per operating procedures. Ensure that work is carried out in an efficient and safe manner. Applies judgment in making adaptation and modifications on all assignments. Performs chemical experiments as assigned for preparation and purification of process intermediates and active pharmaceutical ingredients in a process chemistry laboratory following standard practices. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates experimental results

Key Responsibilities:

• Assembles and operates laboratory (bench scale) equipment and carries out experiments under guidance of a scientist.
• Accurately records and reports experiments and scientific findings per assigned departmental standards in a timely manner to meet project objectives.
• Prepares, edits, and reviews documentation for client updates and pilot plant operations.
• Consistently follows 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.
• Responsible for weekly/monthly inspection of safety equipment.
• Solves problems related to chemical processes.
• Handles chemicals, equipment, and maintains required PPE under protocols established by EHS
• 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.

Education:

• BA or BS in chemistry or related field

Experience:

• Experience working in Pharmaceutical Industry preferred.

• New Graduates are considered

Competencies:

Good knowledge and understanding of chemistry and analytical instrumental technologies. Good knowledge of qualitative and quantitative chemical or microbiological analysis. Good 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 and Dissolution techniques. 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.

Physical Requirements:

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. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.