Standards and Stability Senior Analytical Chemist

CordenPharma Boulder
Boulder, Colorado (US)
Job #1910
Full-time

CordenPharma Boulder
Job #1910

Boulder, Colorado (US)
Full-time

CordenPharma Boulder

Corden Pharma Boulder is focused on the manufacture of highly potent Active Pharmaceutical Ingredients (APIs). We have a proven track record of moving processes for complex APIs from development into commercial production. We have the facilities, infrastructure and workforce to ensure the best chemistry is applied to our projects in the most compliant manner. Ultimately, in partnership with our customers, Corden Pharma Boulder is focused on its health care mission, proudly producing medicines that help patients around the globe survive and enjoy more comfortable lives.

SUMMARY

This is a senior level position in a continuous progression. Performs laboratory tests to determine chemical and physical characteristics or composition of solid and liquid materials for such purposes as quality control, process control, a stability program or product development consistently and accurately. Provide expert technical advice to other development staff and customers.

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

  • >> This position supports a 24/7 manufacturing schedule. The incumbent must be willing to work weekends and/or night shift.
  • >> Run routine and advanced analysis on routine and non-routine samples. Works with the process chemists and QC chemists to reach solutions to unresolved problems and train new analysts.
  • >> Perform equipment calibration, titrant standardization and standard characterization/qualification as required.
  • >> Identify and correct problems with instruments in QC lab. Identify and communicate problems and solutions related to process, procedure and materials to customers. Researches and takes corrective action on anomalous test results. Maintain cleanliness and organization of lab by following safety, regulatory and chemical hygiene policies including GMPs.
  • >> Effectively troubleshoot QC lab instrumentation and methods.
  • >> Perform daily record keeping on SAP and LIMS, print labels, review certificates of analysis and approve final product. Gather and compile data for statistical process control and perform LIMS modification.
  • >> Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste.
  • >> Attend and participate in R&D and Cross Functional team meetings. Develop team skills.

LEADERSHIP & BUDGET RESPONSIBILITIES

Participates and contributes in R&D and Cross Functional team meetings.

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

Bachelor’s degree from four-year college or university in a related science area and 2 years of experience; or 3 to 5 years of related experience; or equivalent combination of education and experience.

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

MATHEMATICAL SKILLS

Ability to execute routine analytical chemistry calculations. Such as determinations of concentration: percent (weight/weight; weight/volume; volume/volume); Parts per million (ppm) and calculation of relative standard deviation (RSD). 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.

ANALYTICAL CHEMISTRY SKILLS

Ability to interpret information obtained from analytical testing techniques such as FTIR, HPLC, UPLC, GC, UV, and Titrations and conduct out-of-specification investigations when required.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of concrete variables in situations where both strict cGMP standards and limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

CERTIFICATES, LICENSES, REGISTRATIONS

None

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 work with hands; and talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to 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 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color 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 is occasionally exposed to fumes or airborne particles, low levels of toxic or caustic chemicals, and outside weather conditions. 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.

  • >> Highly developed analytical skills and knowledge of general or organic chemistry
  • >> Good communication and presentation skills
  • >> Demonstrated research and problem solving skills
  • >> Commitment to QEH&S principles
  • >> Strong computer skills to include word processing, spreadsheets, e-mail and database applications

SALARY

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

Application

Please refer to: Job #1910 – Standards and Stability Senior Analytical Chemist

APPLY HERE