Standards and Stability Analytical Chemist

CordenPharma International; Boulder (CO); Presencial; USD 78.000 - 96.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) matching

Health insurance PPO/HSA

Tuition reimbursement

Paid parental leave

Wellness program

Vision insurance

Descripción de la vacante

Corden Pharma Colorado in Boulder, CO is seeking an intermediate-level Standards and Stability Analytical Chemist to join the Quality Team. The role supports the Stability Program, coordinating study initiation, packaging, labeling, analytical testing, and data compilation to ensure cGMP-compliant stability data for R&D, QC, manufacturing and external clients.

The position involves routine and non-routine testing, instrument troubleshooting (uPLC/HPLC, GC, FTIR, UV/Vis), SAP/LIMS data entry, and

Formación

• Bachelor's Degree from a 4-year college or university; 2 years of related experience and/or training; or equivalent combination of education and experience.
• Ability to read, write and communicate clearly; ability to work independently.
• Experience with analytical techniques such as HPLC/UPLC, GC, FTIR, UV/Vis.

Responsabilidades

• Support 24/7 stability monitoring and testing; weekends and/or nights may be required.
• Run routine and non-routine stability tests and standard characterization/qualification testing.
• Perform equipment calibration, titrant standardization, and stability chamber monitoring.
• Identify and troubleshoot instruments; communicate problems and solutions; perform basic investigations.
• Maintain lab cleanliness and safety per cGMP and regulatory policies; manage waste properly.

Conocimientos

Analytical chemistry

HPLC/UPLC

GMP knowledge

Troubleshooting

Laboratory data review

Educación

Bachelor's degree

Herramientas

SAP

LIMS

Titration equipment

Descripción del empleo

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Standards and Stability Analytical Chemist

Quality Control Regular Full-Time Professional Boulder, CO, US

2 days ago Requisition ID: 1874

Salary Range: $78,000.00 To $95,500.00 Annually

CordenPharmais a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical, and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

Our People Vision

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

SUMMARY

This is the intermediate level technical professional within the Quality Team. Performs analytical tasks accurately and efficiently without supervision to qualify standards and ensure reference materials are available for cGMP analytical testing that support Research and Development, Quality Control, Manufacturing, and external Clients.

Supports the Stability Program. Coordinates study initiation, pull schedule, packaging, labeling, analytical testing. Supports laboratory investigations and compilation of stability data and results. Accountable for confirming that stability samples are properly packaged, exposed to the appropriate conditions, tested, and reported as dictated by cGMP.

ESSENTIALDUTIESAND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• This position supports 24/7 stability monitoring/testing. The incumbent must be willing to work weekends and/or nights
• Run routine and non-routine tests on a variety of samples. Test regular and/or special stability study and standard characterization/qualification testing
• Perform equipment calibration, titrant standardization, and Stability chamber Monitoring and Preventative Maintenance
• Identify and perform basic troubleshooting with instruments in the QC Lab. Identify and communicate problems and solutions related to process, procedure, and materials to the group. Basic investigation and take corrective action on anomalous test results
• Maintain cleanliness and organization of lab by following safety, regulatory, and chemical hygiene policies including cGMPs
• Perform daily record keeping on SAP and LIMS, enter status changes for materials, initiate incident reports
• Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste
• Attend and participate in Quality and Cross Functional Team meetings which include team huddle. Develop team skills
• Understand the cGMP practices to perform stability testing and standards characterization/qualification testing
• Package stability samples and standard material with the appropriate verified materials
• Authors technical documents for the Standards and Stability Programs such as protocols and reports
• Responsible for critical and time sensitive testing, including high potent material and/or other difficult methods
• Capable of performing basic troubleshooting analytical techniques such as uPLC/HPLC, GC, FTIR, UV/Vis, KF titrations, and other wet chemistry techniques
• Ability to support laboratory investigations and assist investigators to determine root cause
• Provide thorough data review for good documentation practices
• Able to work independently without frequent supervisory oversight

LEADERSHIP & BUDGETRESPONSIBILITIES

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.

QUALITY RESPONSIBILITIES

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.

cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

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; 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 exist. 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 necessities.

• Analytical skills and knowledge of general or organic chemistry
• Good communication skills and computer skills

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
• Critical Illness Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Paternal Leave
• Tuition Reimbursement
• Wellness Program
• Vision Insurance

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.