Manager, Tech Transfer (ADX-343-20)
Manager, Tech Transfer (ADX-343-20)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
POSITION SUMMARY:
The Tech Transfer Manager position is responsible for transferring methods and processes from IVD technical team or R&D team to cGMP Manufacturing. This position will lead the technical discussions on troubleshooting internal and external manufacturing processes and work closely with cross-functional teams on process improvements. This position will work closely with Engineering, Operations, Research and Development (R&D) and Quality Control/Assurance (QC/QA) teams to ensure compliant and efficient processing of manufactured products.
RESPONSIBILITIES:
- Maintain compliance with QA and Current Good Manufacturing Processes (cGMP) requirements in all facets of job responsibilities:
- Manage Technical Transfers from IVD AD team and R&D into Operations
- Collaborate cross functionally to manufacture engineering builds and pilot builds of assay components
- Investigate and troubleshoot product testing and process abnormalities
- Lead the development and technical transfer of commercial Operations processes
- Lead the revisions and review of Manufacturing procedures, test methods, work instructions and travelers (batch records)
- Manage and supervise tech transfer associates
- Collaborate with various functional groups on: validation of equipment and cleaning validation; provide technical inputs to process validation plans and protocols; and manufacturing
- Assist and advise various functional group as a technical lead for: Logistics, to include Labeling, Receiving and Shipping, Supply chain, purchasing and inventory, and Sub-contractor management (lyophilization and packaging at vendors); equipment specifications; Quality Control test methods and specifications; and Quality Assurance
- Review, understand, and comply with company HIPAA Security policies and procedures
- Safeguard the privacy and security of protected health information and European Union personal data
- Process and handle European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
EXPERIENCE:
- 5-7+ years of laboratory experience
- 4+ 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
- Technical transfer experience
- Microsoft Office (Word, Excel and Outlook) and flow charting software (preferred)
KEY ATTRIBUTES:
- Drive and determination
- Self Starter driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize and delegate tasks to efficiently move projects forward
- Strong writing and communication skills
- Strong science acumen
- Good interdepartmental communication and documentation skills
EDUCATION:
- MS degree with 1-2 years of industry experience preferably in cGMP and ISO9001 environments
- BS degree with 5-7 years experience, in biology, molecular biology, biochemistry or a related field and/or equivalent combination of education and experience.