Standards & Stability Lead – Research & Development

CordenPharma Boulder
Boulder, Colorado (US)
Job #0419
Full-time

CordenPharma Boulder
Job #0419

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

Responsible for management of reference materials for analytical chemistry testing laboratories. Coordinates the procurement, characterization, qualification, and requalification of reference materials. Incumbent is responsible for ensuring reference materials are available for cGMP analytical testing that support Research and Development, Manufacturing, and external clients.

Responsible for management of the Stability Program. Coordinates study initiation, pull schedule, packaging, labeling, analytical testing, 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.

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

  • Develops a comprehensive understanding of internal, corporate, and ICH stability guidelines to provide support to the Corden Pharma stability program. Responsible for assuring that the Corden stability program and the reference standard program comply with cGMP and with internal procedures
  • Supervises a group of analysts that work a 24/7 schedule. Works flexible hours including weekends and nights to support the group
  • Practices good communication skills and maintains documentation such as protocols, reports, progress reports, and staff conferences in order to inform management of current status of all projects
  • Responsible for the management of reference standard material inventory, storage, tracking, control, procurement, retirement, distribution, and documentation
  • Coordinates the synthesis, characterization, qualification, labeling and issuance of new reference standard materials with Development and Quality Control
  • Collaborates with various departments and partners to ensure the timely delivery of reference standard materials
  • Responsible for determining reference standard purity assignment and retest intervals
  • Responsible for inclusion of client qualification requirements into protocols for reference standard characterization, qualification and requalification activities
  • Responsible for the management of stability sample procurement, storage, tracking,
  • pulls, testing, inventory, and documentation
  • Responsible for generating stability protocols and ensuring that study data are reviewed trended and reported either manually or through a LIMS system
  • Responsible for setting-up and adhering to a schedule for pulling stability samples from the environmental chambers
  • In coordination with Quality Control and Development, the incumbent is responsible for logging and labeling stability samples entering and exiting the environmental chambers.

LEADERSHIP & BUDGET RESPONSIBILITIES

Expected to work interactively and collaboratively in a project team environment. Demonstrates positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and analytical documents. Ability to respond to common inquiries or complaints from customers, and regulatory agencies. Ability to write speeches and documents that conform to prescribed style and format. Ability to effectively present information to management or customers. Extensive knowledge of cGMP documentation practices.

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.

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 and five years’ analytical laboratory experience and/or training; or equivalent combination of education and experience.

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). Capability 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.

Preferable interpretation skills associated with mass spectrometry and nuclear magnetic resonance.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw conclusions. Aptitude to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with abstract and concrete variables.

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 frequently required to sit; stand; walk; work with hands; and talk or hear. The employee must occasionally lift and/or move up to 25 pounds.

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 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.

  • Good computer, math, organizational, leadership, analytical, reading, and writing skills

SALARY

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

Application

Please refer to: Job #0419 – Standards & Stability Lead – Research & Development

APPLY HERE