Provides moderately complex analyses in a chemistry or microbiological environment within defined procedures and practices. Performs analytical methods for moderately complex testing on a variety of in process, stability, and release samples. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results; recommends solutions.
- Conducts testing of materials and products using a variety of equipment and test methods (Advance LC assays: Peptide Map, Glycan analysis as well as others: Reverse Phase, SEC, Titer concentration, CEX, etc.).
- Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions.
- Performs method validation and/or qualification testing as needed.
- Maintains and troubleshoots analytical instrumentation as needed. Cleans and organizes work space.
- 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. May interact with clients.
- Prepares and assists in filing regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients.
- Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
- Writes SOPs and other instructional documents. Authors, reviews and modifies test methods and other lab documents as necessary. Reviews departmental documentation (e.g., Standard Operating Procedures, TMs, and forms).
Bachelor’s degree in physical science, preferably in Chemistry, Biochemistry or Biology.
- Minimum of 2 years of HPLC experience in industry.
- Experience with advance LC assays: Peptide Map, Glycan analysis as well as others: Reverse Phase, SEC, Titer concentration, CEX, etc.
- Working knowledge of EMPOWER is a plus.
- Extensive knowledge of GMP regulations in cGMP manufacturing environment.
- Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred.
- Routine use of MS Excel, MS PowerPoint, MS Access, and MS Word is essential.
- Strong interpersonal and communications skills; written and oral.
- 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.
- 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.
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.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.