DCN Dx is seeking a highly motivated Manufacturing Specialist to join our team in Carlsbad, CA. This role is ideal for someone who thrives in a structured, quality
‑focused environment and has hands-on experience working in a regulated medical device manufacturing operation. The successful candidate must have a good mechanical background as they will be required to operate and maintain production equipment; experience with Biodot and/or Kinematic reel-to-reel systems is a strong plus.
Key Responsibilities
- Perform manufacturing activities in compliance with GMP and ISO 13485 quality standards.
- Prepare and formulate buffers, reagents, and solutions according to approved procedures and specifications.
- Follow Standard Operating Procedures (SOPs) and Work Instructions (WI) with strong attention to detail.
- Maintain excellent Good Documentation Practices (GDP), ensuring all records are accurate, complete, and audit‑ready.
- Support in-process checks, and quality control activities as required.
- Collaborate with Quality, R&D, and Engineering to troubleshoot processes and support continuous improvement initiatives.
- Uphold a controlled manufacturing environment per internal and regulatory expectations.
Qualifications
- 2+ years of experience in a GMP or ISO 13485 regulated manufacturing environment.
- Hands-on experience preparing buffers and handling chemical and biological materials.
- Strong understanding of GDP and controlled documentation processes.
- Experience with manufacturing instrumentation; Biodot reel-to-reel experience is highly desirable.
- Ability to follow detailed instructions, maintain consistency, and deliver high-quality work.
- Strong communication, organization, and problem‑solving skills.
- Ability to work effectively in a fast-paced, team-oriented setting.
Supports a variety of custom/manufacturing tasks under general guidance and in accordance with current GMPs. Supports product scale-up and technology transfer projects under guidance from R&D and MTS into manufacturing. Interface with other teams, including Quality, R&D, and Supply Chain. May supports conversion of R&D documents into controlled Manufacturing SOPs. Manufactures reagents and formulations, performs conjugations, coats materials, assembles devices, kitting, and QC on devices.
31 To 34 (USD) Hourly
