Principal Analytical Chemist - Mass Spectrometry Specialist

About the role

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.

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.
• Carry 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 processes.
• Participate in multi-discipline site activities, such as troubleshooting and problem-solving.
• Develop thorough understanding of QSHE principles and regulatory affairs.
• Compliantly manage the generation and accumulation of hazardous and non-hazardous waste.
• Demonstrate a positive attitude and support a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons.
• Lead team in the development, troubleshooting, transfer, and improvement of chemical processes.
• Work interactively and collaboratively in a project team environment both internally and with clients.

Safety, Environmental & Quality Responsibilities

• Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace; perform job duties in a safe manner utilizing all available knowledge, training, ability, and experience.
• Corden Pharma Colorado is a manufacturer of a variety of pharmaceutical products operating in accordance with Current Good Manufacturing Practices (cGMP), US FDA, ICH Q7, and other global regulations as applicable.
• Adhere to clearly defined procedures in compliance with the principles of cGMP when performing operations across Corden Pharma Colorado.

Qualifications

• 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.

Domestic and international travel required.

Skills

• 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 troubleshooting.
• Knowledge of QbD concepts, specification setting, and cGMP, with experience in contributing to regulatory submissions.
• 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.

Physical Demands

• Regularly required to talk or hear.
• Frequently required to stand, walk, and sit.
• Occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell.
• Occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required: close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Work Environment

• Frequently uses toxic and/or caustic chemicals as well as high potent compounds, with a risk of exposure.
• Occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock.
• Noise level is usually moderate.

Benefits

• 401(k) matching – Corden Pharma contributes 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.