Be an early applicantLess than 25 applicantsPosted by Agency
SSi People ยท 3 days ago
Process Development Associate
Thousand Oaks, CA
Full-time
Onsite
Entry Level
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Responsibilities
Quality Leadership: Provide effective cross-functional quality leadership, managing multiple complex long-term product development tasks (PDT) for late-phase and commercial programs.
Data Evaluation: Conduct science and risk-based evaluations of complex process and product quality data, developing patient-oriented strategies that balance business needs with innovative solutions.
Communication: Clearly communicate complex information to leadership, peers, and regulatory agencies, including during inspectional activities.
Regulatory Compliance: Demonstrate proficiency in cGMP and international regulatory expectations, ensuring compliance and adapting to emerging scientific/technical trends.
Mentorship: Actively mentor new and existing team members to develop core skills in product quality.
Change Control Management: Oversee change control processes and ensure successful initiation, execution, and implementation of change records.
Project Management: Utilize project management tools like Smartsheet to manage multiple projects, ensuring efficient workflow and productivity.
Qualification
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Required
Recent Graduates: Open to candidates with basic lab experience.
Technical Skills: Experience with cell culture, PCR, biological assays, bioreactors, AKTA chromatography, and data analytics/visualization is nice to have.
Educational Background: Degree in chemistry, biochemistry, biology, or related biotechnology sciences field preferred.
Industry Experience: Experience in biotech, medical devices, pharmaceuticals, or GMP manufacturing environments is a plus.
Regulatory Knowledge: Understanding of cGMP and international regulatory expectations.
Communication Skills: Proficiency in oral and written communication of complex information.
Problem-Solving Skills: Strong problem-solving capabilities with a proactive approach to issue resolution.
Preferred
Technical Skills: Experience with cell culture, PCR, biological assays, bioreactors, AKTA chromatography, and data analytics/visualization is nice to have.
Company
SSi People
Founded in 1998 and located in Cranberry Twp., PA.
Founded in 1998
51-200 employees
H1B Sponsorship
SSi People has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Ron Seibert
President and CEO
Company data provided by crunchbase
