Principal Analytical Chemist - Mass Spectrometry Specialist

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Regular Full-Time Professional Boulder, CO, US

Salary Range: $ To $ Annually

Corden Pharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 3,000 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms:
Peptides, Lipids, & Carbohydrates;
Injectables;
Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

Performs and leads analytical research and development activities for the purpose of designing/improving a manufacturing process or technology, as well as producing clinical trial batches by performing the following duties.

Include the following. Other duties may be assigned.

• Provide identification and structural characterization of unknown impurities and degradants of small molecules – particularly peptides
• Develop LC/MS and GC/MS based methods for peptide impurity identification and/or quantitation. Carries the methods through to validation when necessary
• Develop effective collaborations with other analytical chemists within the group and other scientists in project teams. Interact with internal and external customers to explain and defend results
• Introduce innovative analytical approaches to facilitate optimal decision-making
• Generate technical reports independently
• Share knowledge and experience of analytical method development with team and clients
• Propose specifications for control of raw materials, intermediates, in-process testing, and drug substances, based on scientific justification that provides robustness to our processes
• Participates in multi-discipline site activities, such as troubleshooting and problem-solving
• Develop thorough understanding of QSHE principles and regulatory affairs
• Responsible for compliantly managing the generation and accumulation of hazardous and non-hazardous waste

Demonstrates a positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons. Leads team in the development, troubleshooting, transfer, and improvement of chemical processes. Expected to work interactively and collaboratively in a project team environment both internally and with clients.

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy.

CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.

cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is…