Standards and Stability Analytical Chemist

CordenPharma Boulder
Boulder, Colorado (US)
Job #1909
Full-time

CordenPharma Boulder
Job #1909

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 the intermediate level technical professional within the R&D Team. Performs analytical tasks accurately and efficiently without supervision, to qualify standards, support the stability program and support on-going development projects.

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 nights and at both sites.
  • >> Run routine and non-routine tests on a variety of samples. Test special request samples from plants, tech center or process chemists.
  • >> 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 the customer. 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.
  • >> Perform daily record keeping on SAP and LIMS, enter status changes for materials, initiate incident reports and issue approval-for-use tags.
  • >> 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 (B. A.) from four-year college or university; or one to two years related experience and/or training; 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).

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 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 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.

  • >> Analytical skills and knowledge of general or organic chemistry
  • >> Good communication skills and computer skills
  • >> Attention to detail

SALARY

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

Application

Please refer to: Job #1909 – Standards and Stability Analytical Chemist

APPLY HERE