Your next role as a Miracle Maker:
TriLink BioTechnologies is on the lookout for a dynamic Senior Process Engineer to drive innovation and excellence within our Nucleic Acid Products division. In this pivotal role, you'll serve as the technical lead, steering complex projects and ensuring seamless technology transfers within our Contract Development and Manufacturing Organization (CDMO) operations.
As a Senior Process Engineer, your expertise will be at the heart of our production operations. You'll mentor and coach Process Engineers I & II, while advancing and sustaining critical process knowledge. Key areas of focus include Process & Equipment Support, Optimization, and Continuous Improvement.
You'll thrive in a collaborative, multi-functional team environment, working closely with cross-disciplinary teams, including Research & Development, Manufacturing, Supply Chain, Commercial, Legal, IT, Engineering, and Quality. Together, we’ll support the successful introduction of new products (NPI) and ensure the continued success of our commercialized products.
Join us and be part of a team that's pushing the boundaries of biotech innovation!
How you will make an impact:
- Support process and technology transfers of NPIs from R&D to manufacturing.
- Provide technical oversight during technology transfer and manufacturing campaigns
- Provide support for tech transfer for commercialization of pharmaceutical and biotech products
- Collaborate on a cross functional team to define technical requirements for new products and processes
- Design and implement new process equipment as required by new processes
- Independently design and execute experimental protocols, interpreting data from different sources/formats, using statistical analysis, and preparing scientific/operations development reports
- Troubleshoot and resolve equipment issues on the production floor
- Review and develop technical information for the process such as but not limited to Hazard Information/data, P&IDs, Material of Const. Compatibility, PFDs (Process Flow Diagrams), Unit operation Sequence, Material (including consumables) & Energy Balances, and Equipment operating procedures.
- Develop and support implementation of process learning and qualification
- Monitor processes in production for trends in process parameters and deviations and support corrective actions as needed
- Lead or participate in root cause analysis of business critical, safety, or quality investigations
- Drive and lead projects that impact company’s revenue and business strategy
- Coach and mentor Process Engineers I & II in design, process understanding, problem solving, troubleshooting, and project management
- Stay current with industry trends on modern manufacturing technologies (process automation, novel processing equipment, and disposable technologies)
- Perform other functions and duties as required
- The skills and experience that you will bring:
BS in Chemistry, Chemical Engineering, Biochemical Engineering, Mechanical Engineering, or related field with at least 4 years of experience in cGMP industrial setting, or MS / PhD in Chemistry, Chemical Engineering, Biochemical Engineering, or related field with 2 or more years of experience in cGMP industrial setting.
- Verbal and communication skills, including ability to present complex information clearly and concisely, required.
- Experience in small and large molecule scale-up in pharmaceutical development
- Experience in Reaction kinetics, Crystallization, Tangential Flow Filtration (TFF), chromatography is strongly preferred.
- Strong understanding of Statistical Process Control (SPC) and statistical knowledge (DOEs, statistical analysis, statistical software, etc.) is strongly preferred.
- Experience with cGMP, ICH & PDA guidelines, process validation, project management, and control strategy development strongly preferred.
- Experience with automated equipment control systems (DCS / SCADA) highly desired.
- Familiarity with nucleoside/nucleotide chemistry, Oligo synthesis is desirable.
- Experience working in a self-motivated, performance/results oriented, fast paced environment, preferred.
- Proficiency in Excel, Word, PowerPoint is preferred.
- Experience with root-cause analysis tools such as DMAIC and leading process FMEA and risk management exercises is preferred and six sigma certified is a plus.
- Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus.
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