Sr. Chemical Process Engineer

CordenPharmaCordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals drug products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives.Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.SummaryChemical process engineer targeting complex small molecules, peptides, and highly actives for active pharmaceutical ingredients. Performs research and development activities for the purpose of designing/improving a process or technology. And provides process engineering support for manufacturing processes in assigned group, or plant, through proactive problem prevention and troubleshooting, as well as identifying and implementing process improvements. Provides leadership and project management to work groups on large scale projects and technology transfers.Essential Duties And ResponsibilitiesInclude 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 APIsBroad understanding of chemical reactivity, potential exotherms, cross-reactivity, side products, and waste streamsEvaluating new process fits into manufacturing, having good understanding of process fit issues – safety factors, standard cost, equipment, chemistry, and unit operationsPerforming process development at the lab scale, concentrating on key scale-up parameters to scale up from kilo-scale to full production scaleSupporting manufacturing through authoring operating procedures, SOPs, guidelines, PSI packages, developing process models, and assembling technology transfer packagesParticipating 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 requirementsPosition 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 investigationsIdentifying, 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 robustnessDeveloping and implementing detailed plans for projects, including successful technology transfers, and implementing processes into pilot and commercial-scale facilities, providing leadership and technical project managementLeadership & Budget ResponsibilitiesThis 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 ResponsibilitiesEvery 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 their knowledge, training, ability, and experience.QualificationsTo 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 ExperienceA BS in Chemical Engineering and 7 years of demonstrated success in process engineering in a Pharmaceutical or Fine Chemicals Manufacturing environment.Language SkillsAbility 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 SkillsAbility 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 AbilityAbility 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, RegistrationsNone.Physical DemandsThe 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 EnvironmentThe 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 CompetenciesThese 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 improvementsComputer skills, In the areas of: Microsoft Office Products – Word, Excel, PowerPoint; Batch +, statistical analysis programs; and chemical engineering simulation softwareRegularly seeks out new learning opportunities beyond basic skills that can result in innovative approaches to technical issuesDemonstrates clear understanding of technical issues and the requirements of a viable manufacturing process; has demonstrated independent support on multiple (not necessarily simultaneous) processesIdentifies areas where change/continuous improvement is beneficial to the business, and successfully defends and implements projectsAssumes reasonable risk in trying out new, self-generated ideasTakes initiative in setting own goals and work planGenerates and advocates new ideas and concepts and initiatives that are sometimes innovative and cutting edge; and understands their importance to the success of the businessEvaluates projects using sound technical and business judgment, understanding the effects of assumptionsFamiliar with Corden PTCs business goals and strategy; shows understanding of Corden's role and contribution to overall businessSeeks opportunities to present work, for example, routinely makes progress reports to manufacturing management team, at times requires coaching or review for presentations to upper managementCommunicates effectively in writing and verbally within and across departments and to site management; updates are clear, selective, and effectiveIs aware of other projects and processes at Corden, and routinely offers assistance in areas where their expertise can be beneficialLeads teams in the development, transfer, troubleshooting, and improvement of chemical processes; leads teams to implement capital projects of medium to large sizeDemonstrates skills in negotiation and influencing othersSalaryActual pay will be based on your skills and experience.Benefits401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of serviceAccident PlanCritical IllnessDental Insurance