Cambrex
Analytical Chemistry Analyst I
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Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Job Overview Analytical Analysts are responsible for a variety of daily analytical laboratory operations to meet established testing requirements and turnaround time commitments for medical device, pharmaceutical and biotechnology customers.
Responsibilities
Apply a variety of analytical techniques to testing as assigned, including instrumental analysis, gravimetric analysis, titration, appearance, identification, and a wide variety of wet chemistry techniques.
Perform testing per written instruction on a variety of internal and client sample types for a variety of tests (TOC, conductivity, pH, osmolality, container‑closure integrity, subvisible particulate, FT‑IR, Karl Fisher, GC, HPLC, and a vast array of compendial analyses).
Design custom analytical protocols and studies as an experienced analyst.
Execute method validation, suitability, verification, and transfer studies on a variety of tests and/or samples.
Document all lab testing performed to GDP standards.
Draft protocols, test methods, reports, SOPs, and other technical documents.
Communicate and interact appropriately and effectively with clients.
Assist the quality department with investigations and audits.
Stay abreast of industry trends and current technology, design and implement process improvements, recommend strategic investments in equipment, and train other analysts to current standards.
Maintain an orderly and safe working environment.
Ensure all testing is completed in a timely manner, following written procedures in a cGMP compliant environment, and manage quality events.
Ensure the laboratory is maintained in an audit‑ready state, review data for accuracy and completeness, and write technical documents (reports, protocols, test procedures, SOPs).
Qualifications / Skills
Communicate clearly and effectively both orally and in writing with clients and other employees.
Goal‑oriented, with ability to prioritize and manage multiple tasks and numerous projects in a fast‑paced environment.
Strong problem‑solving abilities.
Ability to review, compile, and analyze information to prepare reports.
Education, Experience & Licensing Requirements
Bachelor’s Degree (or advanced degree) in Chemistry or a related science field required.
1+ years of experience in a GMP analytical chemistry testing laboratory.
Experience supporting compendial testing (USP, EP, JP, ACS, FCC, etc.) for wet chemistry, chromatographic, and spectrophotometric analyses.
Experience performing root‑cause analysis for quality events.
Equal Opportunity Statement Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Supervision Received Direct. Works under direct supervision, relying on experience and judgment to plan and accomplish goals within defined procedures and practices.
Travel Not applicable.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee may be required to use hands to finger, handle, or feel and to reach with hands and arms, talk and hear, stand, walk and sit, climb or balance, and regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds. Required vision abilities include close vision, distance vision, and peripheral vision.
Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear appropriate personal protective equipment to perform the job duties, including safety eyewear, respirators, lab coats, gloves, and other items as necessary.
Seniority Level Entry level.
Employment Type Full‑time.
Job Function Research, Analyst, and Information Technology; Pharmaceutical Manufacturing.
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Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Job Overview Analytical Analysts are responsible for a variety of daily analytical laboratory operations to meet established testing requirements and turnaround time commitments for medical device, pharmaceutical and biotechnology customers.
Responsibilities
Apply a variety of analytical techniques to testing as assigned, including instrumental analysis, gravimetric analysis, titration, appearance, identification, and a wide variety of wet chemistry techniques.
Perform testing per written instruction on a variety of internal and client sample types for a variety of tests (TOC, conductivity, pH, osmolality, container‑closure integrity, subvisible particulate, FT‑IR, Karl Fisher, GC, HPLC, and a vast array of compendial analyses).
Design custom analytical protocols and studies as an experienced analyst.
Execute method validation, suitability, verification, and transfer studies on a variety of tests and/or samples.
Document all lab testing performed to GDP standards.
Draft protocols, test methods, reports, SOPs, and other technical documents.
Communicate and interact appropriately and effectively with clients.
Assist the quality department with investigations and audits.
Stay abreast of industry trends and current technology, design and implement process improvements, recommend strategic investments in equipment, and train other analysts to current standards.
Maintain an orderly and safe working environment.
Ensure all testing is completed in a timely manner, following written procedures in a cGMP compliant environment, and manage quality events.
Ensure the laboratory is maintained in an audit‑ready state, review data for accuracy and completeness, and write technical documents (reports, protocols, test procedures, SOPs).
Qualifications / Skills
Communicate clearly and effectively both orally and in writing with clients and other employees.
Goal‑oriented, with ability to prioritize and manage multiple tasks and numerous projects in a fast‑paced environment.
Strong problem‑solving abilities.
Ability to review, compile, and analyze information to prepare reports.
Education, Experience & Licensing Requirements
Bachelor’s Degree (or advanced degree) in Chemistry or a related science field required.
1+ years of experience in a GMP analytical chemistry testing laboratory.
Experience supporting compendial testing (USP, EP, JP, ACS, FCC, etc.) for wet chemistry, chromatographic, and spectrophotometric analyses.
Experience performing root‑cause analysis for quality events.
Equal Opportunity Statement Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Supervision Received Direct. Works under direct supervision, relying on experience and judgment to plan and accomplish goals within defined procedures and practices.
Travel Not applicable.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee may be required to use hands to finger, handle, or feel and to reach with hands and arms, talk and hear, stand, walk and sit, climb or balance, and regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds. Required vision abilities include close vision, distance vision, and peripheral vision.
Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear appropriate personal protective equipment to perform the job duties, including safety eyewear, respirators, lab coats, gloves, and other items as necessary.
Seniority Level Entry level.
Employment Type Full‑time.
Job Function Research, Analyst, and Information Technology; Pharmaceutical Manufacturing.
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