Analytical Chemist III
Job # 0117
CordenPharma Colorado



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 designing, developing and validating analytical methods in support of the analysis of APIs, associated impurities, intermediates and raw materials. This methodology would also include the analysis of product quality, identification and purity, and must be able to withstand the scrutiny of regulatory agency inspection.  Works independently and will supervise other analytical staff and act as an analytical project manager. Alternately, will be seen as a subject matter expert in some aspect of analytical development.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Applies thorough knowledge of analytical chemistry and instrumental analysis to the development of adequate and robust methods for the analysis of APIs, intermediates, raw materials and associated impurities.
  • Demonstrates proficiency in experimental design in order to be able to design and plan method development and in-depth method validation studies.
  • Designs meaningful statistical analysis matrices for method validation data.
  • Incorporates a thorough knowledge of cGMP into the documentation of data in laboratory notebooks.
  • Applies strong technical writing skills in the drafting of development protocols/reports, validation protocols/reports, SOPs, methods, regulatory filings, etc.
  • Performs technical reviews of reports and data generated by colleagues.
  • Run day to day samples in support of Process Development, Technical Services Group, and Manufacturing.
  • Utilizes project management skills in order to design and carry out several projects simultaneously.
  • Maintain the proprietary nature of the Company’s technology, trade secret information and know how in compliance with the Confidentiality Agreement signed upon employment of the employee.
  • Observe safe working practices including completion of required safety training, attendance at scheduled safety meetings, and performance of safe operating techniques in the labs, production areas, and office areas.  Comply with all Quality, Environmental and Occupational Health and Safety policies and procedures and governmental regulations.
LEADERSHIP & BUDGET RESPONSIBILITIES
Directs the work of analytical/QC staff; is competent in soliciting the participation of technical experts from other departments or outside consultants; develops training scenarios and materials to train QC staff on all aspects of analytical methods during tech transfers, either internally or externally.
 
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
Minimum of 8 years’ experience performing analytical chemistry in a pharmaceutical or related environment. Performance at this level assumes an in-depth knowledge of analytical chemistry sufficient to show independent method development capability.  Knowledge of HPLC and specific instrumental techniques such as GC, LC/MS and IR are a requirement. Knowledge of current state of the art of cGMPs and validation requirements is also required. Must have a good understanding of method robustness. Must have a complete understanding of quality systems, regulatory environments, and compendia procedures.
 
EDUCATION and/or EXPERIENCE
Doctoral degree (Ph.D.) in chemistry plus 8 years’ experience or lower degree with 10 years related experience; or equivalent combination of education and experience.
 
LANGUAGE SKILLS
Ability to write reports, proposals, contracts, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
 
REASONING ABILITY
Ability to solve practical problems and deal with a variety of concrete variables in situations where only 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 talk or hear.  The employee frequently is required to stand, walk, and sit.  The employee is occasionally required to work with hands; reach above shoulder height; 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, and color vision.
 
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 and low levels of toxic or caustic chemicals.  The noise level in the work environment is usually moderate.
 
CORE COMPETENCIES   - Please add Core Competencies
The candidate must be able to put into use the following core competencies:
  • Communication – oral and written communication
  • Analytical Methodologies – HPLC/UPLC, Mass spec, GC, HS-GC, IR, UV, IC, ICP-MS
  • Analytical Instrumentation – Use, maintenance, troubleshooting and repair
  • Regulatory Compliance – Excellent working knowledge of ICH guidelines/USP/EP/JP, SME for inspections
  • Quality Compliance – Performing and supporting investigations, determination of root cause
  • Validation & Stability – Experienced in writing protocols, justifications, reports, etc.
SALARY
This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.
 
APPLICATION
Please refer to: Job #0117 – Analytical Scientist III
Submit resume to HR.Boulder@cordenpharma.com

Read full resume here