GENERAL PURPOSE OF JOB
This positions key function is to provide Process Research and Development as part of the Scientific Affairs Organization by conducting research in assigned areas using established methodology or by developing new methodologies where required. Specific responsibilities include: Performing scientific experiments according to existing, approved methods, troubleshooting plant processes to resolve problems, utilize complex analytical techniques to guide research, serve as a technical resource. Incumbents will partner with Analytical Services, New Product Development, Regulatory Affairs, Quality Control, Process Support and Operations groups.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Performs synthetic and process chemistry in support of core department efforts (such as process development, production support, impurity synthesis) by following established processes and procedures, as well as recommending and utilizing published organic methodologies where required. Have full working knowledge of chemical processes, development, scale-up and manufacturing as they pertain to Noramco products and capabilities.
Effectively and accurately operates standard laboratory equipment required to conduct synthetic experiments (such as temperature control units, vacuum pump, drying oven, rotovap, etc). Advanced knowledge of synthetic/organic techniques (such as reflux, distillations, crystallizations, purifications, synthetic methodologies). Familiar with pilot/production chemical processing and equipment. Can train others on basic synthetic/organic techniques and support equipment.
Understand theory and application of complex analytical techniques (such as HPLC, GC, IR, NMR). Ability to perform routine tests following established procedures and interpret output data.
Assists in the evaluation and implementation of new technologies and instrumentation.
Manages process elements of projects such as new product development and introductions, as well as technical transfer to pilot/production scale.
Conducts troubleshooting of plant processes to resolve production or quality problems. Conducts experiments and applies trouble shooting techniques to ensure adequate resolution and recommend path forward. Evaluates new raw material sources to ensure adequate performance in production, and makes appropriate recommendation. Serves as consultant/technical resource to production/engineering/quality control in areas of expertise.
Develops new and maintains existing laboratory procedures, technical report and standard operating procedures. Technical reports must include recommendations that are data based and technically-sound, requiring minimal corrections. Lead criticality assessment and write regulatory documentation with general understanding of impacts to the company. Working knowledge of Noramco documentation and associated systems (such as EDMS, Trackwise, eCoC, eLIMS, SAP).
Maintains and provides notebooks, records, reports, action/check lists and documentation which are current, legible, readily understood, complete and accurate to insure compliance with established procedures and specifications, and are verifiable as required or requested. Reviews fellow scientist's work, including complex records of experimentation, to ensure completeness and accuracy.
Provides advice and consultation on routine and non-routine process and organic chemistry technical issues in areas of expertise. Consults with more senior scientists and management where appropriate.
Coordinates and collaborates with internal business partners to execute technical transfers and implement new processes within area of expertise.
Plans, designs, and conducts research within area of expertise. Analyzes and interprets the results, and summarizes findings for presentation. Collaborates and consults with more senior scientists and managements as needed.
Provides solutions to problems of limited to moderate scope and complexity. Exercises judgment within generally defined policies and procedures to determine appropriate action. Consults senior fellow scientist and management as appropriate.
Routinely interacts with internal laboratory personnel and vendors. May interact with external customer or business partners and contract labs as necessary.
On a project basis may assist with the procurement, installation and calibration of laboratory instruments, equipment and supplies to ensure reliable, prompt, precise and accurate data. May assist with the setup, IQ, OQ and PQ of new equipment.
Trains new laboratory personnel in Noramco procedures/processes and equipment. May train others in new processes/technology or equipment depending on area of expertise in accordance to internal procedures and guidelines.
Practices continuous improvement in the development of new or refined materials, processes, products and/or scientific/business procedures and processes.
Makes decisions regarding analyzing and interpreting data, drawing conclusions, and arriving at timely technical decisions.
Performs other appropriate duties as assigned by the Process R&D Manager.
ADDITIONAL POSITION REQUIREMENTS
Interfaces with multiple departments on a routine basis.
Requires thorough understanding and advanced knowledge of all test methods, procedures, instruments and apparatus for the receipt, labeling, sampling, testing, documentation, release and distribution of all chemical substances associated with NORAMCO, Inc.
Complete understanding and working knowledge of computerized data acquisition, analysis and handling techniques to ensure reliable, prompt, precise and accurate data generation using established methods and procedures.
Maintains an adequately supplied, properly cleaned and safe laboratory to minimize delays, errors and mishaps by using good laboratory and housekeeping practices.
Ability to make independent decisions within general guidelines and to work under minimum supervision.
Maintain and comply with all regulatory programs and guidelines to ensure that all current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) requirements are met.
Observes and promotes all regulatory requirements as defined per applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority.
Follows all applicable aspects of the site Environmental Management System as it pertains to normal job duties. Assumes responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise.
Complies with all regulatory and job training requirements to perform duties of the job.
Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), plus all other relevant job requirements.
Must be available for overtime work on a scheduled or emergency basis.
Remains current in skills and industry trends.
EDUCATION and/or EXPERIENCE
B.S. in Chemistry or related science; Masters or Ph.D is highly preferred.
6 years experience in synthetic/organic chemistry required. Direct experience in process development and/or scale up preferred.
Advanced knowledge of cGMP/cGLP regulations is required. Basic knowledge of pharmaceutical manufacturing and chemical practices/processes is required.