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Standards and Stability Analytical Chemist

4 months ago


Boulder, United States CORDEN PHARMA BOULDER INC Full time
Job DescriptionJob Description


EQUAL 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

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
  • 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 to 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 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 (BA) from a 4-year college or university; or 2 years of related experience and/or training; or equivalent combination of education and experience.

LANGUAGE SKILLS

Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the 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

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

Posting will expire on September 14, 2024