Group Leader, Analytical Chemistry

CordenPharma Colorado
Colorado (US)
Job #1936
Full-time

CordenPharma Colorado
Job #1936

Boulder, Colorado (US)
Full-time

CordenPharma Colorado

CordenPharma Colorado is a highly sophisticated and entrepreneurial mid-sized pharmaceutical manufacturing company located in Boulder, Colorado. Our chemists and engineers are widely recognized for their history of innovation, having developed efficient manufacturing processes for some of the world’s most complex pharmaceutical compounds. CordenPharma Colorado also is acclaimed for its flexible manufacturing facilities and experienced workforce that can handle a wide range of production techniques and volumes. Ultimately, in partnership with our customers, CordenPharma Colorado is focused on its health care mission, proudly producing medicines that help patients around the globe survive and enjoy more comfortable lives.

OUR MISSION

Support our customers, leading pharmaceutical and biotechnology companies, in full and on time (DIFOT) with products and services. Our ultimate stakeholders and beneficiaries are naturally the patients in critical need of the sophisticated medications we manufacture.

We should never forget that the work we all do as an organization is critical to patients and ultimately improves peoples’ lives. There lies our right for existence, challenge, opportunity and motivation that should drive each of us individually at your respective sites and us together company-wide across the entire network.

SUMMARY

Responsible for providing group-level leadership for the analytical chemistry department in accordance with all regulatory requirements. Guides, directs and reviews work done by analytical chemists to support the development of new methods and the 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. The Group Leader also supports and troubleshoots investigations into the performance of all analytical methods.

The Group Leader’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 the group 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
  • >>  Participates in development of new processes by applying analytical skills and training.
  • >>  Initiates and executes development of new and innovative analytical chemistry and methodology.
  • >>  Provides written analytical procedures and reports supporting clinical manufacturing, commercial manufacturing and regulatory needs. Facilitates and supports analytical technology transfers.
  • >>  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. 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
  • >>  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

LEADERSHIP & BUDGET RESPONSIBILITIES

Supervises and directs group directly in cooperation with department manager and project managers. 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 5 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

To apply, please click on the “Apply Here” button. An email box will open to forward a copy of your resume to our Human Resources department for review. Please include the job number and title in the subject line:

Job #1936 – Group Leader, Analytical Chemistry

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