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Lead Process Chemist
2 months ago
Corden Pharma Boulder Inc is an esteemed contract development and manufacturing organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, and drug products. With a workforce exceeding 2,600 globally, we are dedicated to empowering pharmaceutical and biotech firms in their mission to produce life-enhancing medications.
Our operational network spans Europe and the U.S., offering tailored solutions across five distinct technology platforms: Peptides, Lipids & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We are committed to excellence in supporting this network and ensuring the highest quality products for patient welfare.
Position SummaryThe role involves spearheading the technology for the planning, execution, and development of chemical processes. You will ensure that the chemistry aligns with objectives regarding process yields, throughput, and quality, environmental, health, and safety (QEH&S) standards. Responsibilities include the sampling, labeling, and storage of raw materials and intermediates.
Key Responsibilities- Conduct experiments and synthesize small molecules and peptides within a project team.
- Perform peptide synthesis utilizing commercial peptide synthesizers.
- Analyze samples using established methodologies.
- Provide technical support for laboratory or production processes.
- Collaborate effectively in a team-oriented environment.
- Present findings both orally and in written development reports.
- Adhere to Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
- Independently plan and execute experiments aimed at developing viable commercial processes.
- Demonstrate a comprehensive understanding of technical challenges and the requirements for a successful manufacturing process.
- Implement procedures and methods to resolve chemical and technical issues on both laboratory and production scales.
- Ensure that the chemistry meets cost, yield, throughput, and QEH&S targets for assigned processes.
- Lead teams in the development, transfer, or implementation of technology at both laboratory and production scales.
- Develop and support scalable processes while providing technical expertise during laboratory or production operations.
To excel in this role, candidates must possess:
- A Bachelor's degree (BS) in Organic Chemistry and a minimum of 5 years of relevant experience or an equivalent combination of education and experience. Experience in peptide synthesis is preferred.
- Strong analytical skills to interpret scientific and technical documentation.
- Proficiency in advanced mathematical concepts and statistical analysis.
- Ability to apply logical reasoning to complex problems and communicate effectively across various levels of the organization.
- Hands-on experience in organic chemistry laboratory settings.
- Positive attitude and strong background in chemistry or related scientific fields.
- Knowledge of regulatory standards in pharmaceutical manufacturing, including cGMPs and FDA requirements.
- Effective communication skills, both written and verbal.
- Computer proficiency in Microsoft Office and relevant scientific software.
- Ability to work collaboratively in a multi-functional team environment.
The work environment may involve exposure to fumes or airborne particles and low levels of toxic or caustic chemicals. Employees are expected to perform their duties safely and responsibly, utilizing their knowledge and training.