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Principal Analytical Chemist

3 months ago

Boulder, Colorado, United States CORDEN PHARMA BOULDER INC Full time
Job DescriptionJob DescriptionEQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

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 > 2,600 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.

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.

  • 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 to update management and clients on the current statuses 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 company -wide forums, 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 batches of drug substance intermediates and raw materials to be used in clinical registration program.
  • Proposes 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. Expected to work interactively and collaboratively in a project team environment both internally and with clients.

May directly lead 1 – 5 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 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 (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.

  • Scientific leadership in analytical chemistry for API synthesis
  • Presentation and persuasion skills
  • Training and facilitation skills
  • Developed written and verbal communication skills
  • Complete understanding of cGMP and GLP 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 Maternity/Paternity Leave
  • Tuition Reimbursement
  • Wellness Program
  • Vacation – Three Weeks 1st Year
  • Vision Insurance

Job Expires on