Analytical Chemistry Manager
Job # 1813
Corden Pharma Colorado


SUMMARY
Responsible for providing department-level leadership for the analytical chemistry department in accordance with all regulatory requirements. Guides, directs and reviews work done by group leaders and analytical chemists to support the development of new methods and the performance of existing analytical developmental methods. The Manager also ensures the reliability, accuracy and cGMP compliance in support of the validation of new and existing analytical methods. The Manager also supports and troubleshoots investigations into the performance of all analytical methods.
 
The Manager’s further responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.  The incumbent is responsible for creating an environment that encourages technical excellence, developing and coaching technical staff to improve skills, and ensuring high quality technical work.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Guides, directs and reviews work done by the analytical chemistry department to ensure relevancy, accuracy and cGMP compliance in support of the development of new and existing analytical methods
  • Ensures the proper technical resources and skills are in place and appropriately applied to meet and exceed development and manufacturing goals
  • Identifies technical, business, and interpersonal skill development needs of the members of the department and recommend appropriate training, either formal or on the job, and ensure training occurs
  • Appraises the performance, rewards, and disciplines members of the department.  Is responsible for recruiting, hiring and in making salary recommendations for the members of the department
  • Plans and formulates aspects of analytical process as well as HPLC purification research and development proposals such as objectives or purpose of project, applications that can be utilized from findings, cost of project, equipment and human resource requirements. Plans budgets, acquires and ensures maintenance of state of the art analytical equipment
  • Coordinates analytical reports to support regulatory requirements
  • Develops and approves analytical methods and specifications for development products (raw materials, intermediates, drug substances)
  • Ensures that improvements are constantly identified, prioritized and implemented in the primary areas such as process development as well as process improvements, technology transfers, and process robustness
  • Establishes, implements and maintains a system of work standards by developing guidelines and systems that ensure a consistently high level of technical work
  • As a member of the Technical Development and Process Support Management Team, assists in setting goals, milestones and completion dates, evaluates and determines resources (staffing, team makeup)
  • Serves as analytical chemistry SME for internal and external customers.  Ensures customer satisfaction and process improvements
  • Utilizes metrics and work plan to track and continually improve process performance
  • Properly manages the generation and accumulation of hazardous and non-hazardous waste
  • Identifies and provides development opportunities for team members
  • Observes compliant working practices including completion of all required 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
Supervises analytical development staff in coordination with group leaders and project management group. Responsible for department organization, roles and responsibilities. Responsible for effective communication within the department and externally to site and the company as appropriate. Responsible for developing the budget for the analytical chemistry department and ensuring expenses are within the budget.
 
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.
 
EDUCATION and/or EXPERIENCE
The successful candidate will have:
  • Ph.D. in Analytical Chemistry or equivalent education and work experience
  • Minimum of 5 years of supervisory 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
 
LANGUAGE SKILLS
Ability to write reports, proposals, contracts, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from the department, directors, managers, customers, contractors 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 regulatory and quality 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 #1813 - Analytical Chemistry Manager
Submit resume to cpc_hr@cordenpharma.com