Principal Analytical Chemist - Mass Spectrometry Specialist

SUMMARY

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

LEADERSHIP & BUDGET RESPONSIBILITIES

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.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

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.

QUALITY RESPONSIBILITIES

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 required when performing operations across Corden Pharma Colorado.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Doctoral Degree (PhD) in Chemistry plus 3 years' experience; or lower degree with 7 years related experience; or equivalent combination of education and experience.

LANGUAGE SKILLS

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.

MATHEMATICAL SKILLS

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.

REASONING ABILITY

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.

CERTIFICATES, LICENSES, REGISTRATIONS

Domestic and international travel required.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee frequently uses toxic and/or caustic chemicals as well as high potent compounds, and there is a risk of exposure. The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• 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

SALARY

Actual pay will be based on your skills and experience.

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