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13 days old

Diagnostics Scientist/Tech Transfer (SME), Camarillo, CA

Kelly Services
Camarillo, CA 93010
**Kelly Science** is looking for a Subject Matter Expert (SME) to work on microbiology/molecular biology diagnostic tests. Responsible for the technology transfer and process optimization of products.


**Diagnostics Scientist/Technology Transfer (SME), Camarillo, CA**


**Direct Hire**


**Responsibilities:**


+ Responsible for the technology transfer and process optimization of products.

+ Create consistent standards and best practices for the transfer process and ensure success for future transfers.

+ Maintain oversight of product life cycle through execution of continued process verification reports.

+ Working with R&D and other departments within the organization to move away from **external suppliers/manufacturers to bring in-house and implement cost** savings.

+ Obtaining **second source suppliers where needed/available.**

+ Troubleshoot technology issues when quality problems arise.

+ Provide technical expertise for manufacturing changes, deviations, root cause analysis and troubleshooting.

+ Work collaboratively with internal teams as needed.

+ **Oversee all molecular manufacturing steps and lead the development and implementation of strategic improvements to processes required for ensuring manufacturability, scale-up, cost effectiveness, and improvement of product quality.**

+ Participate in preparation of the manufacturing site for the manufacture of new products.

+ Communicates as necessary with required departments, project team members, and other internal customers.

+ Regularly perform process analysis to determine key risks and implements steps that would mitigate negative impacts to process performance and to design robust manufacturing processes.

+ Forecast potential failure points and provide options to reduce or potentially eliminate those failure points.

+ Partner with Validations/Certifications team to push through certification bodies on new assays and any future developments.

+ Provide information and documentation for regulatory submissions as needed.


**Qualifications:**


+ PhD in Molecular Biology or MS in Molecular Biology with 10 years of relevant experience in industry required

+ 4-6 years of relevant experience in PCR technology/product transfer, preferably in a general laboratory or manufacturing environment required

+ 3-5 years of prior experience in Biotechnology, Food Safety or similar industry required

+ Prior leadership experience preferred

+ Knowledge and understanding of scientific and engineering principals

+ Knowledge of downstream bioprocessing unit operations preferred

+ Experience with regulatory agencies and quality management systems highly preferred

+ Six Sigma Green Belt certification or higher a plus

+ Strong knowledge of Microsoft Office suite Excel, Outlook, PowerPoint, SharePoint, etc.


**Skills/Abilities** :


+ Excellent verbal and written communication with the ability to communicate technical/scientific data succinctly and clearly

+ Can work independently as well as within a team environment

+ Ability to optimally balance multiple projects

+ Strong sense of purpose and confidence to address inconsistences and challenge the status quo

+ Excellent analytical, quantitative skills


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-13 Expires: 2022-06-13

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Diagnostics Scientist/Tech Transfer (SME), Camarillo, CA

Kelly Services
Camarillo, CA 93010

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