Sr. Chemical Process Engineer
About The Position
CordenPharma 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. SUMMARY Chemical 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.
Requirements
- A BS in Chemical Engineering and 7 years of demonstrated success in process engineering in a Pharmaceutical or Fine Chemicals Manufacturing environment.
- 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.
- 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.
- 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.
- 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 PTCs 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, troubleshooting, and improvement of chemical processes; leads teams to implement capital projects of medium to large size
- Demonstrates skills in negotiation and influencing others
Responsibilities
- 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, and 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
Benefits
- 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
- Accident Plan
- Critical Illness
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Flexible Spending Account
- Health Insurance PPO/HSA
- Hospital Indemnity Plan
- ID Theft
- Life Insurance
- Paid Maternity/Paternity Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
