Principal Analytical Chemist - Mass Spectrometry Specialist

Corden Pharma Colorado• Boulder, CO, US, CO

7d•$116,000 - $145,000•Onsite

About The Position

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. CordenPharma 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.

Requirements

Doctoral Degree (PhD) in Chemistry plus 3 years’ experience; or lower degree with 7 years related experience; or equivalent combination of education and experience.
Ability to read, analyze, and interpret common scientific and analytical journals, financial reports, and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to write speeches and articles for publication that conform to prescribed style and format.
Ability to effectively present information to top management, clients, public groups, and/or boards of directors.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply statistical concepts such as significant figures, frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
In-depth understanding of separation principles of LC, GC, and ion mobility
In-depth understanding of the principles of tandem mass spectrometry and state-of-the-art ion dissociation techniques
Familiarity with the operation of LC/MS Systems from multiple manufacturers
Familiarity with software assisting compound identification by LC/MS and GC/MS
Demonstrated ability to solve complex problems with advanced LC/MS techniques
Demonstrated expertise in chromatography method development and trouble shoots
Knowledge of QbD concepts, specification setting, and cGMP, with experience in contributing to regulatory submission
Communicates effectively in individual and group settings and collaborates effectively in a multi-disciplinary team environment
Demonstrated project management skills
Consistent record of collaboration with scientists and other stakeholders at external enterprises
Advanced scientific network in the industry and academia
Record of patents and publications
Record of adhering to and promoting lab safety practices
Developed written and verbal communication skills
Complete understanding of cGxP requirements

Responsibilities

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
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.
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.
Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

Benefits

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance