Analytical Scientist II – Method Development & Testing

Location: Málaga

Job Description
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 2,000 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.
Job Overview
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 our Durham, NC site.

Responsibilities
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 with supervision and to evaluate and interpret generated data.

Works on problems of moderate 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.

Qualifications/Skills
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

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

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

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 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

With guidance, prepares well written and organized development reports

Performs other related duties as assigned.

Education, Experience & Licensing Requirements
Skills and Competencies

Working knowledge of experimental design, including chemistry supporting method development

Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC.

Working exposure to cross functional techniques including organic chemistry.

Able to comply to SOPs and basic 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…