Sr. Scientist II (BIO)

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

Execute biopharmaceutical methods and provide general laboratory support for analytical research studies, method development, validation, and cGMP testing services for client projects focused in viral/cellular based therapies and large molecules (clinical through commercial stages). 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.

Responsibilities

• Execute biopharmaceutical methods for in-process control, release testing and stability monitoring of raw materials, 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
• Lead a 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
• Be proficient with molecular biology, biochemistry, and biopharmaceutical analytical techniques
• Good familiarization with analytical techniques
• Participate in 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 (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
• With guidance, prepares well written and organized development reports

• Performs other related duties as assigned.

Qualifications/Skills

• Good understanding of sterile and aseptic techniques
• Good understanding of general laboratory techniques and math principals.
• Working knowledge of experimental design, including chemistry supporting method development
• Working knowledge of scientific method, and experience in Biochemistry or Molecular Biology or Bioassays.
• Good skill using balances, pH meters and pipetting.
• Working understanding of plate-based asses, cell-based assays and separation principles for large molecules.
• Working understanding of analytical techniques and instrumentation such as qPCR, DDPCR, SDS-PAGE, HPLC and titer assays.
• Able to work with BSL1 and BSL2 organisms using aseptic technique
• 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
• Good understanding of chemistry and scientific calculations.
• Ability to read and execute compendial methodologies
• Strong understanding of current FDA and cGMP regulations and good documentation practices
• Good computer skills such as MSWord, MSPowerPoint and MSExcel
• Ability to operate laboratory equipment and computers
• Ability to take direction from experienced scientists and contributes in a team environment
• Good problem-solving skills
• Good attention to details
• Can repeat and follow detailed scientific procedures with supervision
• Able to clearly present results verbally in group meetings and in written progress reports
• 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, SoftMax, Image Lab, Microsoft Word, PowerPoint, and Excel.
• Aptitude, a positive attitude and willingness to gain more skills & knowledge.
• Good attention to detail and good problem-solving skills.

Education, Experience & Licensing Requirements

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

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