Oligonucleotides Synthesis Chemist
Job # 1724
CordenPharma Colorado

 


POSITION SUMMARY
 
Responsible for the design and implementation of synthesis as well as participating in downstream processes to enable meeting customer deliverables for oligonucleotide processes.  Performs Oligonucleotide synthesis for the purpose of designing/improving an oligonucleotide manufacturing process or technology, as well as producing clinical trial batches. 
 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Main focus is in the development and refinement of oligonucleotide synthetic processes such as detritylation, coupling, oxidation, and deprotection.
  • Assists in the development of downstream oligonucleotide processes such as HPLC purification, lyophilization, membrane technologies, and ion exchange chromatography.
  • Initiates and executes development of new and innovative synthesis as well as downstream methodology in the field of Oligonucleotides.
  • Optimizes process parameters during small scale development for large scale production considerations.
  • Provides written procedures and reports supporting clinical manufacturing, commercial manufacturing and regulatory needs.
  • Facilitates and supports technology transfers.
  • Assists with the synthesis of process procedures.
  • Conducts analyses of samples using established or routine methods.
  • Provides technical support to lab or plant processes.
  • Works effectively in a team-oriented environment
  • Presents work orally and in form of written development reports
  • Adheres to cGMP and SOPs in all aspects of work
  • Independently plans and executes experiments, while working in a project team, toward development of viable commercial processes.
  • Demonstrates a clear understanding of technical issues and the requirements of a viable manufacturing process.
  • Executes procedures, processes and methods for solutions to chemical and technical problems on a lab or plant scale.

LEADERSHIP & BUDGET RESPONSIBILITIES
This position has no supervisory responsibilities.  Provides technical expertise to manufacturing.
 
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
Minimum of Bachelor's degree in chemistry from four-year college or university; or equivalent combination of education and experience.
 
LANGUAGE SKILLS
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to write speeches and articles for publication that conform to prescribed style and format.  Ability to effectively present information to top management, public groups, and/or boards of directors.
 
MATHEMATICAL SKILLS
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.  Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
 
REASONING ABILITY
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.  Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases.  Ability to deal with a variety of abstract and concrete variables.
 
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 
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.

  • Demonstrates a positive attitude.
  • Strong background in chemistry or a related scientific field.
  • Working knowledge of regulatory issues in pharmaceutical manufacturing including cGMPs, PSM, OSHA and EPA requirements.
  • Communicates effectively in writing and verbally within the department.
  • Computer skills, in the areas of: Microsoft Office Products – Word, Excel, PowerPoint.
  • Ability to work interactively within a multi-functional team-oriented environment
  • Takes initiative in setting own goals and work plan
  • Hands on organic chemistry laboratory experience
  • Has broad technical knowledge in organic chemistry and process improvement methodology
  • Maintain a well-documented record of work performed in a laboratory notebook, laboratory reports, and campaign reports
  • Experience in the synthesis of oligonucleotides and GE brand synthesizers
  • Has working knowledge of all plant-scale unit operations, scale-up, and plant design considerations
  • Understanding of chemical reactivity, potential exotherms, cross reactivity, side products and waste streams, especially for processes he/she support
  • Regularly seeks out new learning opportunities beyond basic skills that can result in innovative approaches to technical issues
  • Demonstrates clear understanding of technical issues and the requirements of a viable manufacturing process; has demonstrated independent support on multiple (not necessarily simultaneous) processes
  • Identifies areas where change /continuous improvement is beneficial to the business, and successfully defends and implements projects
  • Assumes reasonable risk in trying out new, self-generated ideas
  • Proactive approach to problem identification and resolution.
  • Communicates effectively in writing and verbally within and across departments and to site management; updates are clear, selective and effective

SALARY
This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.
 
APPLICATION
Please refer to: Job #1724 – Oligonucleotides Synthesis Chemist
Submit resume to cpc_hr@cordenpharma.com
 

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