Manufacturing Supervisor - PSP (ADX-223-20) at ArcherDX
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
- Completes production schedule and assigns daily tasks for the team based on business priorities and delivery needs
- Coordinates with cross-functional teams to resolve manufacturing challenges
- Reports and drives process improvements to workflow with the PSP team to create an efficient and lean process flow
- Maintains compliant manufacturing space to support ISO 13485 and other regulatory requirements, to include monitoring of equipment calibration on production floor, cleaning log completion, and appropriate stocking levels of necessary non-stock inventory
- Monitors and provides guidance to support Training Plans, execution of instructor-led training, and updates to all training needs to provide quality products
- Leads the PSP Manufacturing Associates and Technicians by communicating clear expectations, empowering professional development, coaching to seek improvements, upholding Archer’s policies and business procedures
- Support capacity planning activities and maintain appropriate staffing levels for business needs. Propose efficiency gains and automation solutions to increase overall production needs
- Ensures operation of equipment by facilitating repairs and evaluating new equipment and techniques.
- Provides manufacturing information by compiling, initiating, sorting, and analyzing production performance records and data. Answer internal questions regarding PSP process flow and respond to requests within the Archer team.
- Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
- Minimum of 1 year as a Lead or Supervisor in a cGMP manufacturing organization
- 3 years of experience in a Biotechnology, or related environment
- 2 years of experience working in an FDA or ISO regulated environment
- Self-starter: Ability to think on their feet and make decisions quickly, with little to no guidance
- Demonstrated ability to lead a team through mentorship and accountability while maintaining a positive work environment
- Ability to communicate with many levels in the organization
- Ability to translate high level planning and strategy into an effective tactical execution plan through delegation and appropriate organization of tasks
- Professional drive and determination
- Ability to work in a fast-paced and dynamic environment
- Ability to participate with others as a member of the larger team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company
- Bachelor’s Degree preferred or equivalent experience
- Must possess the minimum of a high school diploma or general education degree (GED),
- This position will have 6-10 direct reports, primarily Manufacturing Associates and Technicians.