Job Description Summary
The Sustaining Engineering Senior Chemist / Engineer will serve as a technical leader and provide sustaining engineeringsupport for the manufacturing department. They will be tasked with leading projects related to the improvement, correction, scale-up, and automation of manufacturingprocesses for existing products. Additionally, they will contribute to cross-functional new product introduction teams to ensure thatprocesses and designs meet operational requirements. The successful candidate will haveexperience withpolymers, organic synthesis, macromolecule separations, and/or analytical characterization with excellent attention to detail as well as strong oral and written communication skills.
- Analyze existing manufacturing processes including in-process tests and carry out experimentation to define new (or improve existing) chemical and characterization methods.
- Recommend and lead the implementation of equipment modifications, process modifications, or automation to improve product quality, production efficiencies, manufacturing techniques and production yields for existing products.
- Lead or support CAPA investigations. Performs failure analysis and determines root cause. Designs and validates product enhancements to improve product reliability.
- Work with multi-functional teams including product design and development personnel to ensure that processes and designs meet operational requirements, regulatory requirements and are compatible with manufacturing capabilities.
- Lead or support the development of scale-up processes and equipment from prototype to pilot to full scale manufacturing.
- Synthesize conjugated polymers using standard air-sensitive techniques and perform subsequent characterization and analysis.
- Demonstrates initiative by seeking out new projects that can positively impact the organization by reducing scrap, increasing gross margins and improving productivity.
- Develops and conducts statistical analysis such as Design of Experiments (DOE) and Statistical Process Control (SPC) targeting physical cause of failure for yield loss and improving quality.
- Develops test plans, DOEs and validation IQ/OQ/PQ protocols. Executes protocols and writes reports to ensure equipment/processes meet specifications and regulatory requirements.
- Reviews and evaluates capacity models and anticipates when process scale-up, new equipment, or additional headcount will be required.
- Generates and maintains project timelines and provides updates and feedback to supervisor.
- Develop, write, and edit existing SOPs; ensure validity and accuracy of information
- Train and mentor junior associates on engineering and manufacturing teams.
- Promote a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
- Other responsibilities or projects as assigned byreporting manager.
Successful candidate will possess a PhD Degree in Chemistry (preferred), Engineering, or Life Science, minimum of 5+ years of relevant industry experience or a combination of equivalent education and experience.
In depth experience in polymer science/material science/organic synthesis
• Experience with FPLC/HPLC/GPC
• Experience with UV/Vis and/or fluorescence spectroscopy is preferred
• Experience with Antibody Conjugation and Flow Cytometry is preferred
• Demonstrated organizational and project planning skills
• Strong diagnostic, analytical and technical ability
• Strong technical writing skills
• Ability to translate an issue or problem statement into study strategy
• Experience working in an environment with quality systems and guidelines such as GLP and GMP processes is essential
• Experience with Six Sigma, MiniTab, or statistical analysis
• Demonstrated leadership within a team
• Demonstrated (internal) customer service excellence
• Ability to articulate and balance risk and reward when making complex decisions
• Ability to influence others without direct reporting ties
• Multi-task to cover a variety of job functions
• Comfortable working in a fast-paced environment