Purisys is a trusted CDMO partner for custom pharmaceutical API and other chemical synthesis projects with capabilities unique in the industry. Built over a 40-year history, our expertise allows us to support a diverse range of custom API development projects from proof of concept, bench chemistry to full-scale product commercialization – with particular strengths in full-service clinical Phase I/II and small volume, orphan drug commercial API GMP synthesis. Our broad ranging, and often specialized, chemistry capabilities make us the partner of choice for technically intensive and complex projects. Purisys also has an industry-leading track record in compliance with US FDA cGMPs and other global regulatory bodies. For more information on the company please visit https://purisys.com GENERAL PURPOSE OF JOB This position’s key function is to provide AR&D support as part of the Research and Development Organization by conducting research in assigned areas under general supervision using established and new methodology. Specific responsibilities include: analysis of routine research samples; validation and maintenance of existing methods; and supporting the development of new analytical methods for existing, transferred and new products. Incumbents will partner with Process Development, Regulatory, Technical Services, Quality Control, Quality Assurance, and Operations groups. ESSENTIAL DUTIES AND RESPONSIBILITIES Performs analytical chemistry work necessary to ensure the identity, purity, quality and strength of materials, by following established test methods and procedures. Effectively and accurately performs general analytical techniques and operates analytical equipment (such as HPLC, GC, HPLC/MS, GC/MS, X-Ray Diffraction, Particle Size Laser Diffraction), troubleshoots common equipment issues and interprets spectra and data results. May support routine quality investigations, plant process troubleshooting, process development activities and assessment of unusual process/testing occurrences by performing analytical testing and problem solving activities. Maintains existing analytical methods, and may assist with the development, validation and transfer of new, routine analytical test methods. Assist with writing and updating protocols, procedures and reports. Working knowledge with 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 basic documentation for completeness and accuracy. Provides analytical advice and consultation on common technical analytical chemistry issues. Consults with more senior scientists and management where appropriate. Executes experiments under direct guidance in support of research efforts. Provides solutions to problems of limited scope and complexity. Exercises judgment within defined policies and procedures to determine appropriate action. Consults more senior scientist and management as appropriate. Interact with other internal laboratory personnel and support vendors as necessary. May assist with the procurement, installation and calibration of laboratory instruments, equipment and supplies to ensure reliable, prompt, precise and accurate test data. May assist with the setup, IQ, OQ and PQ of new equipment. May train new laboratory personnel in existing procedures/processes and lab equipment. Performs other appropriate duties as assigned by the Analytical Services Manager. ADDITIONAL POSITION REQUIREMENTS Interfaces routinely with operations and technical personnel. Requires general understanding and working knowledge of most frequently used test methods, procedures, instruments and apparatus for the receipt, labeling, sampling, testing, documentation, release and distribution of all chemical substances. General understanding and knowledge of computerized data acquisition, analysis and handling techniques to ensure reliable, prompt, precise and accurate test data using established methods and procedures. Maintains an adequately supplied, properly cleaned and safe laboratory to minimize test delays, test errors and mishaps by using good laboratory and housekeeping practices. Ability to make independent decisions within standard guidelines and to work under general 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. SUPERVISORY RESPONSIBILITIES None. May provide work or task direction to new employees, temporary assignees or co-op students. QUALIFICATIONS EDUCATION and/or EXPERIENCE B.S. in Chemistry or related science. Masters or Ph.D preferred. Senior level -Minimum of 4-6 years of related experience in instrumental and wet chemical techniques required. Analytical level - Minimum of 2-4 years of related experience in instrumental and wet chemical techniques required. Working knowledge of cGMP/cGLP regulations and practices is highly preferred. LANGUAGE SKILLS Ability to read, analyze and interpret common scientific and technical journals, technical procedures or government regulations. Occasionally responds to basic inquiries or complaints from internal and external customers. Ability to write common analytical reports, routine business correspondence and technical procedural instructions/manuals. Creates presentations and articles using combination of template formatting and original or innovative techniques or style. Ability to effectively present information and respond to questions from groups of internal managers and employees. Makes effective and persuasive presentations on common to moderately complex topics. MATHEMATICAL SKILLS Apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. REASONING ABILITY Ability to deal with problems involving several concrete variables where limited standardization exists. Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in moderately complex phases. OTHER SKILLS ABILITIES OR QUALIFICATIONS Working knowledge of analytical instrumentation use and routine preventative maintenance. Ability to trouble-shoot common or routine instrumentation malfunctions following ICMS investigation protocols. Use computer software and customize programs to meet business needs, including word processing and mathematical applications. Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production. Must be able to work with people, influencing their output and work behavior. Must be able to work in situations where speed and sustained attention are essential, performing a variety of tasks without loss of production. Ability to perform under stress in cases of emergency, critical or hazardous situations. Hands-on working experience in a number of the following techniques: HPLC, HPLC Mass Spectrometry, GC, Particle Size Analysis, XRPD. PHYSICAL DEMANDS While performing the duties of this job, the employee is frequently required to stand; walk; sit; reach with hands and arms, use hands to finger, handle, or feel. Must have fine motor skills to perform precise laboratory manipulations. The employee is occasionally required to: climb or balance; stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds; occasionally lift and/or move up 40 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, color vision, and ability to adjust focus. Must be able to qualify for respiratory protective equipment use, and must be able to smell surrounding environments. Purisys provides opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Job Type: Full-time Pay: $80,000.00 - $120,000.00 per year Benefits: 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance Work Location: In person
Salary: $80,000 - $120,000 a year
Employment Type: ["Full-time"]
Qualifications
[]