Senior Chemical Process Enginner
Job # 0518
Corden Pharma Boulder

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.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
 
Knowledge of plant scale unit operations, scale-up, and plant design considerations, especially as they apply to the production of APIs
 
Broad understanding of chemical reactivity, potential exotherms, cross-reactivity, side products and waste streams.
 
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.  
 
Supporting manufacturing through authoring operating procedures, SOPs, guidelines, PSI packages, developing process models and assembling technology transfer packages.
 
Participating in or leading technology transfer from one manufacturing site to another; developing and implementing innovative process scale-up technologies.
 
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.
 
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.
 
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; Batch +, statistical analysis programs, and chemical engineering simulation software
 
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
 
Familiar with Corden PTC’s business goals and strategy; shows understanding of Corden’s role and contribution to overall business
 
Seeks opportunities to present work, for example, routinely makes progress reports to manufacturing management team, at times requires coaching or review for presentations to upper management.
 
Communicates effectively in writing and verbally within and across departments and to site management; updates are clear, selective and effective
 
Is aware of other projects and processes at Corden, and routinely offers assistance in areas where their expertise can be beneficial.
 
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
 
SALARY
This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.
 
APPLICATION
Please refer to: Job #0518 –  Senior Chemical Process Engineer
Submit resume to hr.boulder@cordenpharma.com