Process Engineer/Chemist

  • Full-time

Company Description

NanoComposix is a privately-held R&D, and manufacturing company that develops innovative nanomaterials for research and commercial markets supporting medical devices, and pharmaceuticals.  We manufacture hundreds of different variants of metal and metal-oxide core/shell nanocomposites for a wide range of applications including biosensors, medical devices, clinical diagnostics, and optical effects.  Our mission is to help our clients bring nano-enabled products to market.  We’re passionate about what we do and are looking for smart, energetic, and self-motivated individuals who take pride in their work to join our fun and innovative team in this exciting industry.  

Benefits include medical and dental insurance, paid vacation and personal days, and retirement plan with company-match.

Job Description

The Process Chemist or Engineer works cross-functionally with Development, Manufacturing, and Quality to support process development of nanomaterials from external and internal R&D sources through design control, process validation, to release to manufacturing /commercialization, and post-release product support /continuous improvement. The Process Chemist responsibilities encompass Quality and Process Engineering functions.                                      

 

 

II.        Principal Duties and Responsibilities

  • Owning, writing, and executing Process Validations, IQ/OQ of equipment, and cleaning validations in a GMP environment
  • Support nanomaterial product development from R&D through commercialization
  • Support analytical method development and validation.
  • Leading technical and operations expert for new product introductions, manufacturing and production process development, improvement, and sustaining efforts
  • Independently and collaboratively design, executes, and directs controlled experiments and projects to optimize processes, address yield and quality issues, drive implementation of solutions in controlled manufacturing and production environment
  • Batch Record, SOP development and training
  • Validation Protocol development through execution and reporting
  • Collaborates with other engineers, scientists, product managers, and staff to review the projects design, manufacturing, and test documentation; ensures that program or contract quality requirements are met
  • Identifies root causes of problems in the manufacturing and production process; recommends and/or implements corrective measures.

 

 

 

 

 

Qualifications

 Education

  •   B.Sc., or M.Sc. with synthetic research and development experience preferred

  Experience

  • At least five years prior lab experience preferable as part of a PSET or MSAT group.
  • At least eight years prior biotech, medical device, diagnostic, pharmaceutical, or nanotechnology industry experience specifically focused on optimization, scale-up, and technology transfer
  • Experience owning, writing, and executing Process Validations, IQ/OQ of equipment, and cleaning validations.
  • Experience in identifying, onboarding, and validating complex new equipment and production lines in a pharmaceutical or biotech setting is required
  • Experience in production support, process development, and project management skills
  • Experience in aseptic processes desired

  Knowledge/Skill

  • Detail-oriented
  • Strong analytical and problem-solving skills
  • Laboratory skills
  • Excellent verbal and written communication skills
  • Extensive knowledge of or the ability to quickly learn manufacturing and production processes
  • Proficient with Microsoft Office Suite, laboratory analytical and statistical software, and other related software

Additional Information

APPLICATION PROCESS

Qualified candidates should submit a resume.

Candidates must be eligible to work in the United States. 

nanoComposix is an EEOC employer. Military highly encouraged to apply.