Senior Process Engineer, Oligonucleotides - Job 1719
CordenPharma Colorado




Corden Pharma 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. Corden Pharma 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, Corden Pharma Colorado 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 the design and implementation of processes to enable meeting customer deliverables for Oligonucleotide processes.  Performs research and development activities for the purpose of designing/improving a process or technology and provides process engineering support for manufacturing processes in the Oligonucleotides department and plant through proactive problem prevention and troubleshooting as well as identifying and implementing process improvements.  Provides leadership and technical project management to work groups on large scale projects and technology transfers.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
 
DESIRED SKILLS
  • Knowledge of plant scale unit operations, scale-up, and plant design considerations, especially as they apply to the production of APIs and Oligonucleotides.
  • Evaluating new process fits into manufacturing; having good understanding of process fit issues – safety factors, standard cost, equipment, chemistry, unit operations.
  • Performing process development at the lab scale, concentrating on key scale-up parameters to scale up from kilo-scale to full production scale.  Developing and implementing innovative process scale-up technologies.
  • Supporting manufacturing through authoring operating procedures, SOPs, guidelines, PSI packages, developing process models and assembling technology transfer packages.
  • Performing process validation on an API process.
  • Knowledge and application of QEH&S regulatory compliance principles related to chemical and pharmaceutical manufacturing including FDA, cGMPs, EPA, OSHA and PSM requirements.
  • Position may require day-to-day support to manufacturing and process development, at times requiring attention outside of the normal work hours.  Support includes troubleshooting and continuous improvement of equipment and processes as well as participation in change control, deviations, and investigations.
  • Identifying, evaluating, developing and implementing process improvements and optimization that: reduce costs; improve yield, cycle times and product quality; resolve or prevent environmental, health and safety impacts; reduce down time; improve process consistency; and improve process robustness.
  • Developing and implementing detailed plans for projects, including successful technology transfers and implementing processes into pilot and commercial-scale facilities, providing leadership and technical project management.
LEADERSHIP & BUDGET RESPONSIBILITIES
This position has no direct reports but is responsible for providing leadership for continuous improvement of processes.  Periodic assignments of significant responsibility levels for large projects and technology transfers. Expected to work interactively and collaboratively in a project team environment.
 
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 BS in Chemical Engineering and 7 years of demonstrated success in process engineering in a pharmaceutical or fine chemicals manufacturing environment.  Oligonucleotide experience a plus.
 
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 define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
 
CERTIFICATES, LICENSES, REGISTRATIONS
Not mandatory for this position.
 
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 frequently required to stand, sit, and talk or hear.  The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; 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, depth perception, and ability to adjust focus.
 
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 moving mechanical parts, fumes or airborne particles, low levels of toxic or caustic chemicals, outside weather conditions, and vibration.  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.
  • Ability to understand and apply statistical design of experiments and draw sound conclusions from the results; uses results when solving problems, or proposing improvements.
  • Computer skills, In the areas of: Microsoft Office Products – Word, Excel, PowerPoint; statistical analysis programs
  • 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
  • Takes initiative in setting own goals and work plan
  • Generates and advocates new ideas and concepts and initiatives that are sometimes innovative and cutting edge, and understands their importance to the success of the business
  • Evaluates projects using sound technical and business judgment, understanding the effects of assumptions
  • Communicates effectively in writing and verbally within and across departments and to site management; updates are clear, selective and effective
  • Leads teams in the development, transfer, trouble-shooting, and improvement of chemical processes; leads teams to implement capital projects of medium to large size.
  • Demonstrates skills in negotiation and influencing others
  • Complete understanding of cGMP principles
SALARY
This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.
 
APPLICATION
Please refer to: Job #1719 – Senior Process Engineer, Oligonucleotides. 
Submit resume to cpc_hr@cordenpharma.com.
 
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