Description

Thank you for considering a future opportunity with Cambrex! If you are interested in joining our team but don't see a current role that fits your background, please submit your resume here. If we have future opportunities that match your skillset, we will contact you.

While we are not currently hiring for a role linked to this specific posting, we would love to connect with talented individuals who are interested in potential future positions. By joining this talent pipeline, you will be the first to be notified when suitable opportunities arise within our Analytical R&D function.

Cambrex's Analytical R&D positions will be on-site at one of our 14 locations. Locations include: Agawam, Massachusetts, Charles City, Iowa, Durham, North Carolina, East Rutherford, New Jersey (HQ), Edinburgh, UK, High Point, North Carolina, Karlskoga, Sweden, Liege, Belgium, Longmont, Colorado, Paullo, Milan, Italy, Tallinn, Estonia, Waltham, Massachusetts, Waterford, Ireland, and Wiesbaden, Germany.

Sample Job Description:

• Job Summary

  Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles.

   

  Routinely and effectively interacts with clients to discuss data and methods.

   

  Works on problems of moderate and sometimes advance scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.

   

   

   

  Duties and Responsibilities

  • Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines
  • Independently develop and evaluate methodologies, design and implement experiments.
  • Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability.
  • Maintains compliant records with little or no supervision
  • Able to write technical documents with assistance
  • Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks
  • Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions
  • Sets up various instrumentation for testing according to written test methods and with little to no supervision.
  • As needed, troubleshoots laboratory instrumentation
  • Leads a sample project with assistance
  • May participate in client level meetings, with approval
  • May lead and develop other team members.
  • May advise clients on site procedures.
  • May act as a team /project lead supporting scheduling of project tasks and deliverables
  • Responsible for ensuring compliance with cGMP and other regulatory guidelines.
  • Analyze information for technical correctness and accuracy
  • Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor
  • Perform routine laboratory procedures in a timely and efficient manner
  • Gain familiarization with analytical techniques
  • Participate cGMP activities
  • Provides input on SOPs and client questions
  • Maintain laboratory equipment and supplies as directed
  • May support peer-led laboratory investigations process with assistance
  • Maintain a clean and safe work-space
  • Maintain laboratory notebook and/or computer files (i.e. LIMS) according to standard, accepted practices
  • Participate in group and project meetings as required
  • Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems
  • Attend seminars as required
  • Participate in and comply with all current safety, health and environmental programs
  • Shows initiative and interest in learning new techniques and tests
  • Participates in technical discussions and brainstorming sessions
  • Communicates issues or challenges to senior staff and/or management
  • May review test data acquired by others and witness others' notebooks
  • Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs
  • Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed
  • Provides input on SOPs and client questions
  • Effectively and routinely provides training.
  • With guidance, prepares well written and organized development reports
  • Performs other related duties as assigned.

   

  Skills and Competencies

  • Working knowledge of experimental design, including chemistry supporting method development
  • Working knowledge of advanced laboratory techniques
  • Working exposure to cross functional techniques including organic chemistry.
  • Subject matter expert in one or more instruments (i.e. GC, LC, dissolution, TGA/DSC)
  • Able to comply to SOPs and have understanding of regulatory compliance
  • Working knowledge of scientific concepts, principles and procedures
  • Actively and positively engages with team and supports process improvements
  • Ability to read and execute compendial methodologies
  • Strong understanding of current FDA and cGMP regulations
  • General knowledge of chemistry and scientific calculations
  • Hands on experience in analytical techniques such as HPLC, GC, etc
  • Strong computer skills
  • Ability to operate laboratory equipment and computers
  • Ability to take direction from experienced scientists and contributes in a team
  • Environment
  • Ability to effectively train and mentor others
  • Good problem-solving skills
  • Good attention to details
  • Can repeat and follow detailed scientific procedures
  • Able to clearly present results verbally in group meetings and in written progress reports
  • Routinely and effectively presenting findings to clients
  • Good interpersonal skills and is willing to ask questions about procedures and concepts
  • Aptitude and willingness to gain more skills and knowledge in support of GMP regulations
  • Good written and verbal communication skills
  • Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel.
  • Aptitude and willingness to gain more skills & knowledge.
  • Good attention to detail and good problem-solving skills.

   

   

  Education, Experience, and Other Qualifications

  • B.S./B.A. Chemistry with 8+ years of experience in related industry or MS with 4+ years related experience or PhD with 0+ years related experience

   

  Supervision Received: 

  Works under limited supervision.

   

  Physical Demands, Work Environment, and Travel

  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 is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.  Specific vision abilities required.

   

  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 is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.

  Travel:  

  Little to no expected travel time.

   

  LIMITATIONS AND DISCLAIMER

   

  The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position.

   

  All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities.  Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

   

  This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position.  Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.

   

  Requirements are representative of minimum levels of knowledge, skills, and/or abilities.  To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.

   

  All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.

  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.

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