Process Development Associate (ADX-43-20)
Process Development Associate (ADX-43-20)
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 enhances 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.
POSITION SUMMARY:
The Process Development Associate position is responsible for creating, improving and maintaining commercial operations processes. This position will work closely with Operations, Research and Development (R&D) and Quality Control/Assurance (QC/QA) teams to ensure compliance and efficient processing of the manufactured products.
RESPONSIBILITIES:
Maintain compliance with QA and Current Good Manufacturing Processes (cGMP) requirements in all facets of job responsibilities:
- Technical Transfers from R&D into Operations
- Investigate and troubleshoot equipment, product testing and process abnormalities
- Creation and development of commercial Operations processes
- Author, revise and review standard operation procedures, test methods, work instructions and travelers (batch records)
- Accurately document all necessary relevant information in a clear and concise manner per cGxP
- Collaborate with, assist and advise various functional groups:
- Validation of equipment and processes
- Manufacturing
- R&D
- Logistics
- Labeling
- Receiving and Shipping
- Supply chain, purchasing and inventory
- Sub-contractor management (lyophilization and packaging vendors)
- Facilities
- Equipment sourcing, purchasing and installation
- Equipment calibrations and/or maintenance
- Quality Control
- Test methods and specifications
- Quality Assurance
- NCRs, CAPAs and Deviations
- 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.
EXPERIENCE:
- 3-5+ years of laboratory experience
- 3+ years in an industry setting
- Experience in cGMP and ISO9001 environments
- Process development experience to help improve and scale-up current manufacturing processes
- Must have demonstrated expertise in authoring SOPs or similar process directed documentation
- Familiarity with statistical data analysis, Next Generation Sequencing, qPCR/PCR and general molecular biology techniques and equipment
- Microsoft Office (Word, Excel and Outlook) and flow charting software (preferred)
EDUCATION:
- MS degree with 0-3 years of experience, or
- BS degree with 3-5 years experience, in biology, molecular biology, biochemistry or a related field and/or equivalent combination of education and experience.