• Analytical Chemistry Analyst I

    Cambrex High Point (Agawam, MA)


    Company Information

     

    You Matter to Cambrex.

     

    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.

     

    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

     

    Analytical Analysts are responsible for a variety of daily Analytical laboratory operations to meet established testing requirements and turnaround time commitments to our medical device, pharmaceutical and biotechnology customers.

    Responsibilities

    + Apply a variety of analytical techniques to testing as assigned; including but not limited to: 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 (i.e. TOC, conductivity, pH, osmolality, container closure integrity, subvisible particulate, FT-IR, Karl Fisher, GC, HPLC, and a vast array of compendial analyses, etc.)

    + Experienced analysts provide expertise in the design of custom analytical protocols and studies

    + Execute method validation / suitability / verification / transfer studies on a variety of tests and/or samples.

    + Adequately document all lab testing performed to GDP standards

    + Experienced analysts 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

    + Experienced analysts 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

    + Responsible for ensuring all testing is completed in a timely manner, following written procedures in a cGMP compliant environment, and managing quality events.

    + Ensure the laboratory is maintained in an audit ready state, review data for accuracy and completeness, and write technical documents (e.g. reports, protocols, test procedures, SOPs, etc.).

    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.

    + A bility to review, compile, and analyze information to prepare reports

     

    Education, Experience & Licensing Requirements

     

    + Bachelor’s Degree (or advanced degree) in Chemistry or 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

     

    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.

    #LI-SK1

    Supervision Received: Direct

     

    Works under direct supervision. Relies on experience and judgment to plan and accomplish goals within defined procedures and practices. Seeks management direction for problems of diverse scope.

     

    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.

     

    While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to 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. Specific vision abilities required by this job 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.

     

    While performing the duties of this job, 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 the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.