Cambrex Corporation

Cambrex Corporation

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Locations

Cambrex Corporation Website
3501 Tricenter Blvd
Durham, NC 27713
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Cambrex Corporation
4180 Mendenhall Oaks Parkway
High Point, NC 27265
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Jobs and Careers

Cambrex Durham

Jobs

Cambrex High Point

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About

Cambrex is a leading global contract development and manufacturing organization that provides drug substance, drug product and analytical services across the entire drug lifecycle. Enjoy working with our experts to accelerate your therapeutics into the market.

Drug Product | Analytical Services | Cambrex Careers | Why Join Cambrex

Position Descriptions

Biopharma Lab Technician

RESPONSIBILITIES:

  • Maintain Inventory and supply of Reagents for Biopharmaceutical Labs
  • Clean Laboratory Incubators on a weekly basis
  • Complete the Cleaning Safety Checklist for Biopharmaceutical Labs
  • Collect and pack Biohazard Waste from Labs - Waste management
  • Ordering and stocking laboratory consumable supplies
  • Maintain cleanliness and organization of Laboratories by participating in 6-Sigma activities
  • Prepare Media for testing
  • Log Reagents into LIMS upon receipt
  • Collect, clean, and organize Glassware
  • Wear appropriate PPE
  • Comply with GLP, GMP and safety regulations
  • Perform other related duties as required

QUALIFICATIONS:

  • Maintain Inventory and supply of Reagents for Biopharmaceutical Labs
  • Clean Laboratory Incubators on a weekly basis
  • Complete the Cleaning Safety Checklist for Biopharmaceutical Labs
  • Collect and pack Biohazard Waste from Labs - Waste management
  • Ordering and stocking laboratory consumable supplies
  • Maintain cleanliness and organization of Laboratories by participating in 6-Sigma activities
  • Prepare Media for testing
  • Log Reagents into LIMS upon receipt
  • Collect, clean, and organize Glassware
  • Wear appropriate PPE
  • Comply with GLP, GMP and safety regulations
  • Perform other related duties as required
  • BioWork Certificate preferred
Glassware Technician

RESPONSIBILITIES:

  • As Glassware Washer, you will remove dirty and or broken glassware from the labs areas.
  • You will wash and dry glassware and distribute to appropriate locations within the labs.
  • Additionally, you will maintain glass washing facility by keeping it clean and swept.
  • You will be responsible for sterilizing glassware and other items using glass washers.
  • As Glassware Washer, you will comply with GLP or GMP and safety regulations.
  • You will also perform other related duties as required.

QUALIFICATIONS:

  • High School Diploma and 1+ years of experience or BioWork Certificate required.
  • Ability to coordinate multiple tasks and interact with lab staff.
  • Ability to work independently.
  • Good organizational and time management skills.
  • Must be able to lift 25 lbs.
  • Must wear protective eyewear and lab coat.
Associate Scientist

RESPONSIBILITIES:

  • Strong operational knowledge of analytical instrumentation including HPLC, GC, cKF, LC/MS, FTIR, UV-VIS, NMR
  • Experience with Water Empower 3 and Agilent Masshunter for chromatographic data analysis.
  • Demonstrated success in developing and validating analytical methods to support release and stability testing for drug substances and drug products
  • Participate in routine client meetings to drive project deliverables and timelines
  • Assist in writing new SOPs and optimizing processes to support standalone analytical workflows
  • Work effectively in a team environment to grow capabilities and add value to the customer
  • Draft and release certificates of analyses, reports, protocols, and methods per cGMP and ICH practices

QUALIFICATIONS:

  • Strong operational knowledge of analytical instrumentation including HPLC, GC, cKF, LC/MS, FTIR, UV-VIS, NMR
  • Experience with Water Empower 3 and Agilent Masshunter for chromatographic data analysis.
  • Demonstrated success in developing and validating analytical methods to support release and stability testing for drug substances and drug products
  • Participate in routine client meetings to drive project deliverables and timelines
  • Assist in writing new SOPs and optimizing processes to support standalone analytical workflows
  • Work effectively in a team environment to grow capabilities and add value to the customer
  • Draft and release certificates of analyses, reports, protocols, and methods per cGMP and ICH practices
Associate Scientist (Biopharma)

RESPONSIBILITIES:

  • Develop biopharmaceutical assays, bioassays, and validate the methods for GMP use
  • Techniques include but are not limited to: qPCR, virus titer by plaque assay, ELISAs, Endotoxin, total DNA, total RNA, HPLC-(QQQ, UV, CAD, ELSD, RI, FLD, MS), SDS PAGE, Western blots, HIAC particle counting, and more
  • May assist DMPK-ADME (Tox) group in HPLC-QQQ testing and conduct similar tests on complex biopharmaceutical products
  • Cell culture, viral plaque assays, and other bio-assays (xCelligence)
  • Assist in writing new SOPs, implementing efficient and effective workflows, and onboarding new methods and instruments in a growing group in a fast-paced work environment.
  • May spend 60-80% of time in the lab and 40-20% writing methods, reports, protocols, and SOPs
  • ICH validation and stability testing for a variety of molecularly diverse biomolecules and viral active pharmaceutical ingredients
  • Execution of analytical testing as per approved protocols, current Pharmacopoeia, and test methods etc.
  • Work effectively in a team environment to grow capabilities and add value to the customer
  • Draft and release certificates of analyses, reports, protocols, and methods per cGMP and ICH practices
  • May interact with clients to report on method development activities/results
  • Assist sample management in receiving biological materials and manage samples in LIMS

QUALIFICATIONS:

  • Life Science degree preferably in biochemistry, molecular biology, or analytical chemistry
  • 2-5+ years of cGMP biopharmaceutical method development and QC testing
  • Experience with SoftMax Pro (Plate reader), Quant Studio 5 (qPCR), Image Lab Secure (Bio-RAD ChemiDoc MP), Empower, Mass Hunter
  • Experience with DMPK-ADME bioanalytical techniques: HPLC-MSMSMS
  • Prospective analysts should demonstrate the following important “soft” skills
  • Attention to detail
  • Ability to prioritize
  • Efficient worker
  • Customer focus
  • Driven (we prefer to foster growth and promote internally)
  • Ability to troubleshoot and develop a variety of methods to perform to a high degree of reproducibility
Scientist

RESPONSIBILITIES:

  • Strong operational knowledge of analytical instrumentation including HPLC, GC, cKF, LC/MS, FTIR, UV-VIS, NMR
  • Experience with Water Empower 3 and Agilent Masshunter for chromatographic data analysis.
  • Demonstrated success in developing and validating analytical methods to support release and stability testing for drug substances and drug products
  • Participate in routine client meetings to drive project deliverables and timelines
  • Assist in writing new SOPs and optimizing processes to support standalone analytical workflows
  • Work effectively in a team environment to grow capabilities and add value to the customer
  • Draft and release certificates of analyses, reports, protocols, and methods per cGMP and ICH practices

QUALIFICATIONS:

  • Strong operational knowledge of analytical instrumentation including HPLC, GC, cKF, LC/MS, FTIR, UV-VIS, NMR
  • Experience with Water Empower 3 and Agilent Masshunter for chromatographic data analysis.
  • Demonstrated success in developing and validating analytical methods to support release and stability testing for drug substances and drug products
  • Participate in routine client meetings to drive project deliverables and timelines
  • Assist in writing new SOPs and optimizing processes to support standalone analytical workflows
  • Work effectively in a team environment to grow capabilities and add value to the customer
  • Draft and release certificates of analyses, reports, protocols, and methods per cGMP and ICH practices
Scientist (Biopharma)

RESPONSIBILITIES:

  • Works independently and as part of the group to develop, validate, and execute biopharmaceutical tests in support of viral/cell based and large molecule therapeutics. 
  • The Scientist 1 will demonstrate strong knowledge in viral/cell-based assays and or large molecule assays and may support development and testing for infectious titer, host cell DNA, Host cell protein, ELISAs, Capillary Electrophoresis, SEC-MALS, HPLC/UPLC, mass spectrometry, particulate analysis, aggregation, purity and potency, activity assays, next generation sequencing, etc.  
  • Work effectively in a team environment to grow capabilities and add value to the customer
  • Ensures proper creation of test methods, validation protocols, validation reports, stability protocols and reports, and development reports in accordance with SOPs and ICH and FDA guidelines.
  • May interact with clients to report on method development activities/results.
  • Assist in writing new SOPs, implementing efficient and effective workflows, and onboarding new methods and instruments in a growing group in a fast-paced work environment
  • Supports troubleshooting and problem-solving activities for biopharmaceutical tests

QUALIFICATIONS:

  • Doctoral degree in Biochemistry, Molecular Biology or similar with 0-2+ years of related experience, MS degree with 5+ years, or BS degree with 10+ years related experience, or equivalent combination of education and experience.
  • Must demonstrate a positive attitude and have strong communication skills.
Research Scientist – Process Chemistry

RESPONSIBILITIES:

  • Carry out multistep organic syntheses, isolation, and purification of targeted products under direct supervision of a senior member of the team.
  • Conduct routine analysis of starting materials, reaction mixtures, intermediates and products using appropriate instrumentation.
  • Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource usage.
  • Routinely generate summaries and reports on completed experimental work for internal and external use.
  • Work to ensure teamwork and cooperation exists within the group at all times.
  • Conduct laboratory operations in a safe manner.  Maintain familiarity with the company’s chemical hygiene plan.  Exhibit safety awareness and safe work practices.
  • Follow responsible actions regarding chemical disposal.  Maintain compliance with all regulations at the federal, state, and local levels.
  • Address routine administrative requirements in a timely fashion.
  • Demonstrate effective communication skills (both written and oral).  Participate in project team meetings with customers.
  • Work closely with manufacturing and GMP operations to coordinate project-related equipment and activities. Assist in the transfer of processes to the manufacturing team.
  • Performs other related duties as assigned.

QUALIFICATIONS:

  • Carry out multistep organic syntheses, isolation, and purification of targeted products under direct supervision of a senior member of the team.
  • Conduct routine analysis of starting materials, reaction mixtures, intermediates and products using appropriate instrumentation.
  • Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource usage.
  • Routinely generate summaries and reports on completed experimental work for internal and external use.
  • Work to ensure teamwork and cooperation exists within the group at all times.
  • Conduct laboratory operations in a safe manner.  Maintain familiarity with the company’s chemical hygiene plan.  Exhibit safety awareness and safe work practices.
  • Follow responsible actions regarding chemical disposal.  Maintain compliance with all regulations at the federal, state, and local levels.
  • Address routine administrative requirements in a timely fashion.
  • Demonstrate effective communication skills (both written and oral).  Participate in project team meetings with customers.
  • Work closely with manufacturing and GMP operations to coordinate project-related equipment and activities. Assist in the transfer of processes to the manufacturing team.
  • Performs other related duties as assigned.
Metrologist

RESPONSIBILITIES:

  • Carry out multistep organic syntheses, isolation, and purification of targeted products under direct supervision of a senior member of the team.
  • Conduct routine analysis of starting materials, reaction mixtures, intermediates and products using appropriate instrumentation.
  • Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource usage.
  • Routinely generate summaries and reports on completed experimental work for internal and external use.
  • Work to ensure teamwork and cooperation exists within the group at all times.
  • Conduct laboratory operations in a safe manner.  Maintain familiarity with the company’s chemical hygiene plan.  Exhibit safety awareness and safe work practices.
  • Follow responsible actions regarding chemical disposal.  Maintain compliance with all regulations at the federal, state, and local levels.
  • Address routine administrative requirements in a timely fashion.
  • Demonstrate effective communication skills (both written and oral).  Participate in project team meetings with customers.
  • Work closely with manufacturing and GMP operations to coordinate project-related equipment and activities. Assist in the transfer of processes to the manufacturing team.
  • Performs other related duties as assigned.

QUALIFICATIONS:

  • Carry out multistep organic syntheses, isolation, and purification of targeted products under direct supervision of a senior member of the team.
  • Conduct routine analysis of starting materials, reaction mixtures, intermediates and products using appropriate instrumentation.
  • Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource usage.
  • Routinely generate summaries and reports on completed experimental work for internal and external use.
  • Work to ensure teamwork and cooperation exists within the group at all times.
  • Conduct laboratory operations in a safe manner.  Maintain familiarity with the company’s chemical hygiene plan.  Exhibit safety awareness and safe work practices.
  • Follow responsible actions regarding chemical disposal.  Maintain compliance with all regulations at the federal, state, and local levels.
  • Address routine administrative requirements in a timely fashion.
  • Demonstrate effective communication skills (both written and oral).  Participate in project team meetings with customers.
  • Work closely with manufacturing and GMP operations to coordinate project-related equipment and activities. Assist in the transfer of processes to the manufacturing team.
  • Performs other related duties as assigned.

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