Technical Process Scientist II at Invitae (Formerly ArcherDx)
Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life. We are passionate about what we do!
The Technical Process Scientist position is responsible for process development, process engineering, and maintenance of commercial operations. 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.
Job performance will involve a variety of activities including:
- Maintain compliance with QA and Current Good Manufacturing Processes (cGMP) requirements.
- Analyze and develop processes to support manufacture and testing of product lines in cGMP or RUO settings.
- Investigate and troubleshoot equipment, product testing and process abnormalities to improve measurable process outputs.
- Identify, drive, and document cross-functional communication for process improvement projects
- Create and engineer commercial operations processes capable of meeting or exceeding determined key performance indicators.
- Author, revise and review standard operating 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 various functional groups such as QC, Manufacturing, Logistics and Engineering to assist in technical transfer or improvement of the processes and test methods
- Understand the scientific principles required for manufacturing products, including the interaction of the chemistry, equipment, aseptic processes, and ISO systems
- Ensure that an accurate instruction set and process flow document, describe the process as performed and adhere to the control strategy for the discrete manufacturing steps.
- Prepare, review, approve, or provide technical support for preparation of relevant technical documents as required, such as change controls, regulatory submissions, deviation investigations, validations, processing records, procedures, process flow documents, control plans, annual product reviews, etc.
- Support and/or lead the development and implementation of process improvements to improve process control, and/or productivity.
- Participate in development and implementation of process improvements including capital expansions and technical projects.
- Work within or lead cross-functional teams to implement functional objectives and deliver on business plan and quality objectives.
- Review, understanding, and compliance with Invitae 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 Invitae for purposes of personalized molecular pathology.
- Drive and determination
- Ability to work in a fast paced and dynamic environment
- Ability to participate with others as a member of the 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.
- Strong communication and presentation skills
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
- MS degree with 3+ years of experience OR BS degree with 8+ years’ experience, in biology, molecular biology, biochemistry or a related field and/or equivalent combination of education and experience.
- 2 years of experience is with laboratory and industry settings operating in a regulated environment.
- Experience in regulated environment such as ISO13485, ISO90001, cGMP
- 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, qPCR/PCR and general molecular biology techniques, root cause analysis, and equipment.
- Next Generation Sequencing operating, and analysis experience preferred.
- Microsoft Office (Word, Excel and Outlook) and flow-charting software (preferred)
- Lean Six Sigma or other continuous improvement technique experience/certification a plus
In Colorado, our competitive compensation package includes a base salary starting from $75,280 per year. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.