POSITION SUMMARYThe Senior Chemist performs a wide variety of analytical tasks for formulation development and product release. These tasks include development of analytical test methods, testing of incoming materials, commercial products, research and development pharmaceutical dosage forms, and medical device combination products to support formulation and product release activities. This position operates under minimal guidance from management or senior staff. The Senior Chemist ensures ProMed's brand, philosophy, systems, policies, and procedures are properly implemented and observed.
ESSENTIAL DUTIES & RESPONSIBILITIESPosition duties and responsibilities include, but are not limited to the following:
- Lead the development and implementation of analytical test methods for the analyses of experimental and commercial products using high-performance liquid chromatography (HPLC) and related methods.
- Serves as the lead analyst for development projects
- Leads test method transfer activities
- Research and troubleshoot new test methods; improve and revise procedures
- Develops test methods for new pharmaceutical dosage forms
- Drafts test method validation, test method transfer, and instrument qualification protocols
- Records experiments in a laboratory notebook
- Reports experimental data to internal and external customers
- Writes development and validation reports
- Performs data analysis to support product development decisions
- Participates in project team meetings with internal and external customers
- Complies to the ProMed Quality Management System, as well as customer and regulatory requirements
- Troubleshoots, repairs, and calibrates laboratory instrumentation
- Participates in project planning
- Performs root cause investigations
- Performs peer review of analytical data
- Trains junior staff on test methods and instrumentation
- The employee is expected to develop acceptable work habits, skills, knowledge, and contributions consistent with the Associate Chemist position level
- This job also requires performing other duties as assigned
QUALIFICATION, EDUCATION & EXPERIENCETo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:- Bachelor's Degree in chemistry or related field, plus 6 to 10 years' experience in analytical chemistry or related field
- Expertise with HPLC and other common laboratory instrumentation
- Expertise with Waters Empower 3 chromatography data system
- Experience with analytical test method development and validation
- Demonstrated knowledge of current Good Manufacturing Practices and other regulatory requirements
- Problem-solving and critical thinking skills
- Experience with qualifying laboratory instrumentation
- Experience performing laboratory investigations
- Experience performing statistical analysis of analytical data
- Strong interpersonal, written, and verbal communication skills
Preferred:- Experience with LIMS and/or ELN
- Experience leading, supervising, and training junior staff
- Demonstrated interest in analytical chemistry, pharmaceuticals, and medical devices
- Experience with MS Office
- Clearly conveys ideas and receives information effectively
- Self-starter with a proven ability to successfully work with minimal supervision
- Professional, courteous, and friendly personality
- Working knowledge of English (verbal and written)
WORK ENVIRONMENTThe work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job.
- Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
- Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
- The noise level in the work environment is usually minor;
- Duties are performed indoors;
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDSWhile performing the duties of this job:
- The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
- Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
- The position requires the individual to meet multiple demands from several people and interact with internal and external people;
- Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
- Employee may have duties involving walking on even or uneven surfaces;
- Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
- Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment;
- It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently.
- Employee must see and hear on a continuous basis as well as speak frequently;
- Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.
1st Shift
