Senior Chemist / Engineer - Sustaining Engineering

Becton, Dickinson and Company   •  

San Diego, CA

Industry: Healthcare

  •  

5 - 7 years

Posted 43 days ago

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.

Job Description

  • 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.

Qualifications:

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

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