Chemist III-PSG

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview Reporting to the QC Supervisor, the QC Chemist III is responsible for raw material, in-process, isolated intermediate, or finished good testing in a GMP laboratory environment. The QC Chemist III will provide technical knowledge to the role and assist junior staff with troubleshooting activities as necessary. Responsibilities Follow all FDA, ICH, cGMP, cGLP, DEA, and internal SOP requirements as they related to Phase III and commercial GMP laboratory operation. Adhere to all OSHA and company safety requirements and practices. Perform a wide variety of chemical analyses for release of raw materials, in-process, intermediates, finished goods, and stability. Support/maintain laboratory programs such as calibration/preventive maintenance, IQ/OQ/PQ. Perform in-depth out of specification or out of trend laboratory investigations of non-complying or aberrant results. Support the implementation and training efforts for new laboratory instrumentation or software. Perform data review of QC data as necessary. Independently perform troubleshooting of laboratory equipment. Strong working knowledge of HPLC, UPLC, GC, and GC-HS. Working knowledge of wet chemistry. Write controlled documents such as reports, test procedures, SOPs, etc. Evaluate validity of test results. May assist in training employees within the department. Topics may include, but are not limited to, instrumentation, analytical concepts, or equipment troubleshooting. Perform and document method transfer from Analytical Development. May perform method evaluation experiments as necessary. Handle, analyze and dispose of hazardous samples and waste. May need to provide off-shift coverage as required. Maintain laboratory solutions, inventory and notebooks utilizing a LIMS. Coordinate and communicate project status with a proven ability to handle various assignments and organize workload to meet timelines. May interact with outside vendors and other departments. Extensive knowledge and proven ability to use a wide assortment of the analytical instrumentation available at Cambrex Charles City. Proven ability to handle various assignments and organize workload to meet timelines. May act as departmental subject matter expert (SME). All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental objectives and assignments not specifically detailed in this section may be assigned. Qualifications/Skills Working knowledge of analytical instrumentation (GC, HPLC, and UPLC). Working knowledge of MS, NMR, XRPD, IC, and ICP-OES preferred. Strong chemistry theory. Proven ability to handle various project loads with strong attention to detail. Ability to work in a fast-paced, deadline-driven work environment. Effective communication skills (oral, written). Ability to work independently with little or no direct supervision. Education, Experience & Licensing Requirements BS/BA in Chemistry/Biology or related science field required Advanced degree (MS, PhD) in Chemistry/Biology or related science field preferred Minimum of 6-7 years (with a BS) or 5-6 years (with an advanced degree) of direct laboratory experience with chromatographic techniques in an industry related setting. Preferably in pharmaceutical manufacturing. Strong cGMP experience. Experience testing against USP and EP compendia Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.BS/BA in Chemistry/Biology or related science field required Advanced degree (MS, PhD) in Chemistry/Biology or related science field preferred Minimum of 6-7 years (with a BS) or 5-6 years (with an advanced degree) of direct laboratory experience with chromatographic techniques in an industry related setting. Preferably in pharmaceutical manufacturing. Strong cGMP experience. Experience testing against USP and EP compendiaFollow all FDA, ICH, cGMP, cGLP, DEA, and internal SOP requirements as they related to Phase III and commercial GMP laboratory operation. Adhere to all OSHA and company safety requirements and practices. Perform a wide variety of chemical analyses for release of raw materials, in-process, intermediates, finished goods, and stability. Support/maintain laboratory programs such as calibration/preventive maintenance, IQ/OQ/PQ. Perform in-depth out of specification or out of trend laboratory investigations of non-complying or aberrant results. Support the implementation and training efforts for new laboratory instrumentation or software. Perform data review of QC data as necessary. Independently perform troubleshooting of laboratory equipment. Strong working knowledge of HPLC, UPLC, GC, and GC-HS. Working knowledge of wet chemistry. Write controlled documents such as reports, test procedures, SOPs, etc. Evaluate validity of test results. May assist in training employees within the department. Topics may include, but are not limited to, instrumentation, analytical concepts, or equipment troubleshooting. Perform and document method transfer from Analytical Development. May perform method evaluation experiments as necessary. Handle, analyze and dispose of hazardous samples and waste. May need to provide off-shift coverage as required. Maintain laboratory solutions, inventory and notebooks utilizing a LIMS. Coordinate and communicate project status with a proven ability to handle various assignments and organize workload to meet timelines. May interact with outside vendors and other departments. Extensive knowledge and proven ability to use a wide assortment of the analytical instrumentation available at Cambrex Charles City. Proven ability to handle various assignments and organize workload to meet timelines. May act as departmental subject matter expert (SME). All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental objectives and assignments not specifically detailed in this section may be assigned.