MS&T Analytical Group Leader
Job # 0118
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 providing group-level leadership in the support of manufacture of cGMP-compliant drug substances. Guides, directs and reviews work done by a group of analytical chemists to support the development of new and performance of existing analytical developmental methods. The Group Leader also ensures the reliability, accuracy and cGMP compliance in support of the validation of new and existing analytical methods. Also supports and troubleshoots investigations into the performance of all analytical methods.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Guides, directs and reviews work done by a group of analytical chemists to ensure relevancy, accuracy and cGMP compliance in support of the development of new and existing analytical methods.
  • Establishes specifications raw materials, intermediates and products that allow for the safe, efficient and compliant production of pharmaceutical APIs.
  • Supports the site compliance-related activities
  • Works with external labs in support of method transfers (transfers in and out).
  • Manages the work-flow of the group to achieve department and site goals.
  • Performs group-level management activities (reviews, etc.)
  • 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.
  • Other duties as required or assigned.
LEADERSHIP & BUDGET RESPONSIBILITIES
Supervises development staff directly or through group leaders and project managers. Responsible for department organization, roles and responsibilities. Responsible for effective communication within the department and externally to site and the company as appropriate.
 
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 10 years of practical work experience in API pharmaceutical analytical development, including broad understanding of API Regulatory approval processes.  Expert experience in the design and implementation of analytical techniques.  Ability to formulate and articulate cohesive strategy for method development, including regulatory aspects.  Advanced communication skills necessary to interrelate with external customers and other departments within the company structure.
 
EDUCATION and/or EXPERIENCE
Ph.D. in Analytical Chemistry or equivalent education and work 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
The candidate must be able to put into use the following core competencies:
  • Communication – oral and written communication
  • Administration - able to organize group to achieve group goals and objective
  • Analytical Methodologies – HPLC/UPLC, Mass spec, GC, HS-GC, IR, UV, IC, ICP-MS
  • Analytical Instrumentation – Use, maintenance, troubleshoot 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, comprehensive knowledge of industry quality standards for method development, validation and documentation
  • 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 #0118 – MS&T Analytical Group Leader
Submit resume to hr.boulder@cordenpharma.com

Read Full Job Posting Here