Principal Analytical Chemist

CordenPharma Colorado
Colorado (US)
Job #1913
Full-time

CordenPharma Colorado
Job #1913

Colorado (US)
Full-time

CordenPharma Colorado

CordenPharma Colorado is a highly sophisticated and entrepreneurial mid-sized pharmaceutical manufacturing company located in Boulder, Colorado. Our chemists and engineers are widely recognized for their history of innovation, having developed efficient manufacturing processes for some of the world’s most complex pharmaceutical compounds. CordenPharma Colorado also is acclaimed for its flexible manufacturing facilities and experienced workforce that can handle a wide range of production techniques and volumes. Ultimately, in partnership with our customers, CordenPharma Colorado is focused on its health care mission, proudly producing medicines that help patients around the globe survive and enjoy more comfortable lives.

SUMMARY

Performs analytical research and development activities for the purpose of designing/improving an analytical or manufacturing process or technology by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
Other duties may be assigned.

  • >> Leads large and/or multiple teams to accomplish technology transfers and/or development projects.
  • >> Applies analytical and organic chemistry skills to the improvement of processes.
  • >> Responsible for participating in the budget process of research projects and/or technology transfers.
  • >> Initiates and executes the development of new and innovative analytical chemistry and methodology. Provides written analytical procedures and reports to support manufacturing and regulatory needs. Lead analytical technology transfer activities associated with a method or project.
  • >> Develops a comprehensive understanding of internal, corporate, and ICH stability guidelines to provide support to the Corden stability program.
  • >> Develops and applies analytical techniques at a process scale (e.g., process chromatography)
  • >> Responsible for the analytical sections of process procedures.
  • >> Develops key technologies and transfer strategies that function well in a manufacturing environment.
  • >> Plans and formulates aspects of analytical research and development proposals such as objectives or purpose of project, applications that can be utilized from findings, cost of project, equipment and human resource requirements.
  • >> Identifies analysis points and develops methods and procedures for monitoring projects. Devises and completes method validation studies.
  • >> Practices excellence in verbal and written communication skills in order to inform management of current status of each project. Maintains documentation such as analysis data and procedures and progress reports in accordance with GLP and company policies.
  • >> Submits patents, presents at scientific conferences and publishes in scientific journals.
  • >> Investigates new analytical technologies and equipment with the aim of practical utilization in new and existing manufacturing processes.
  • >> Develops expertise in key advanced analytical techniques.
  • >> Analyzes and releases batches of drug substance and/or intermediates to be used in clinical registration program.
  • >> Propose analytical specifications for control of raw materials, intermediates, in-process testing and drug substances for in-house use and regulatory filings.
  • >> Participates in manufacturing site activities, such as troubleshooting and analytical problem solving.
  • >> Develops thorough understanding of QEH&S principles and regulatory affairs. Impacts analytical process development in at least two areas.
  • >> Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste.

LEADERSHIP & BUDGET RESPONSIBILITIES

Demonstrates 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.

May directly lead one to five employees. Carries out leadership responsibilities in accordance with Corden policies and applicable laws. Responsibilities include interviewing, hiring and training employees, planning, assigning and directing work, appraise performance, reward and discipline employees, address complaints and resolve problems.

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 of their knowledge, training, ability and experience.

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 (Ph.D.) in chemistry plus three years’ experience or lower degree with seven to ten 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, 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 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.

  • >> Presentation and persuasion skills
  • >> Training and facilitation skills
  • >> Developed written and verbal communication skills
  • >> Complete understanding of cGMP and GLP requirements

SALARY

This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.

Application

To apply, please click on the “Apply Here” button. An email box will open to forward a copy of your resume to our Human Resources department for review. Please include the job number and title in the subject line:

Job #1913 – Principal Analytical Chemist

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