Production Chemist – Lateral Flow
- Full-time
Company Description
NanoComposix is a privately-held R&D and manufacturing company that develops innovative nanomaterials for research and commercial markets. 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.
We are an established high technology company with a track record of steady and substantial growth. If you thrive in a brilliant, fast-paced, dynamic, and mission-driven environment, join us!
Benefits include medical and dental insurance, paid vacation and personal days, retirement plan with company-match, and an annual bonus program with opportunity for stock ownership in this employee-owned business. Salary is commensurate with experience.
Job Description
A Production Chemist position is available at nanoComposix. This is a highly collaborative and hands on opportunity. Responsibilities include working with the team to ensure that the lateral flow production schedule is maintained, all quality control measures are in place and followed, all reagents and cards are manufactured, processed and characterized as specified under a formal quality system, all team members are trained and have all of the tools necessary for success. See full list of responsibilities below.
For more information, please visit our career page at nanoComposix.com/pages/careers.
Responsibilities/Duties:
- Execute lab activities including bioconjugation to surfaces or particles.
- Supervise and assist with production on BioDot reel to reel dispense system.
- Meticulously document production into batch records and forms associated with NCX quality system.
- Collaborate with lateral flow development team to transfer multiple assays to manufacturing.
- Participates in Lean Initiatives and Activities.
- Assist in nonconforming and customer complaint investigation.
- Ensuring that the manufacturing area is compliant with all required FDA, ISO and other applicable regulatory agency standards and documentation.
- Ensuring that the manufacturing area is compliant with the requirements associated with EHS, HR, Facilities, Housekeeping, etc.
- Maintains appropriate inventory levels of raw materials and supply items used in manufacturing.
- Develop and initiate policies and/or procedures for continual metric improvement.
- Assist when needed in both external and internal inventory audits.
- Review manufacturing records for accuracy and completeness in accordance with GMP.
- Coordinate lab shutdown activities to prevent production disruption.
- Actively contribute to team discussion, project planning and project execution.
- Maintain an organized, safe and efficient work area at all times.
- Resolve routine issues and escalate non-standard or critical issues.
- Support new product transfer and validation and implementation of process improvements.
- Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per ISO, FDA and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Qualifications
Requirements:
- BS in Chemistry or Biological Sciences.
- 3-10 years’ experience in cGMP chemistry manufacturing for lateral flow applications.
- Experience performing bioconjugations and other wet chemistry techniques.
- Knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485
- Ability to perform laboratory operations with a high degree of skill, efficiency and professionalism
- Basic understanding of manufacturing systems (documentation, compliance, inventory control, production scheduling/controls, etc.)
- Must be very detail oriented
- Must work well in a fast-paced, start-up environment
- Solid understanding of the product and manufacturing processes
- Excellent written and verbal communication skills
- Occasional safe lifting of up to 45 pounds
- US citizenship or green card
Desired Skills:
- Experience working in a cGMP manufacturing environment.
- Experience documenting production activities in batch records in compliance with a quality management system.
- Experience fabricating, functionalizing, and processing nanomaterials.
- Experience with reel to reel dispense systems for lateral flow applications.
- Experience with QC testing of lateral flow cards.
Additional Information
APPLICATION PROCESS:
Qualified candidates should submit a resume and cover letter. The cover letter should include information on how your previous experience relates to the job requirements and your availability. Specific examples are of interest. You will not be considered without a cover letter. Candidate should be prepared to discuss and explain the technical details of their past experiences during the interview process.
All your information will be kept confidential according to EEO guidelines.