Job Title: Process Development Associate
Location: New Albany, Ohio (Fully Onsite)
Hours: 8:00 AM – 5:00 PM
Are you eager to apply your lab skills in a dynamic biotech environment? Do you have a passion for process development and a desire to contribute to cutting-edge projects? Join our team as a Process Development Associate, where you will play a key role in supporting the development and optimization of our products.
Key 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.
Experience & Qualifications:
- 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.
If you are passionate about process development and ready to contribute to groundbreaking projects, we want to hear from you! Apply today to become our next Process Development Associate and lead the way in innovation and excellence.
About SSi People:
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.