The Application Scientist will be a key member of the Commercial Organization and Customer Success team. The Customer Success teams mission is to make customers successful in adopting the technologies, retaining our customers, and reinforcing a positive brand and customer experience. You’ll accomplish this by acting as a trusted expert to our customers, offering prompt technical advice, troubleshooting assistance and generating high quality customer training material. What’s unique about this role is it’s a junction of science and business. You’ll have the opportunity to work cross-functionally to support product launches and serve as a technical expert on the inner workings of our products. Your role will directly increase customer satisfaction and loyalty contributing to the overall success of the business. If you want to use your scientific skills in a business focused role; and have a passion for helping customers, this could be the right opportunity for you.
typical roles and responsibilities for Application Scientist
- Design, implement and maintain (GxP) QA and QC programs, and the compliance infrastructure. This includes the SOP system, training programs, and performing internal and external audits.
- Lead and manage inspections by FDA, other regulatory agencies and commercial partners.
- Coordinate with regulatory agencies and other external auditors to build trust and confidence in company quality systems.
- Lead quality input on contracts and serve as the primary contact for the negotiation of quality agreements.
- Work with the company’s external suppliers including clinical research organizations (CROs) and contract labs to ensure consistent quality and compliance.
- Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GXP regulations.
- Oversee compliance (GMP and GCP) auditing program to fulfill regulatory requirements.
- Develop, manage and monitor adherence to the overall Quality and Compliance budget.
- Develop, analyze and report business metrics and highlights.
Requirements for Application Scientist – Life Sciences
- Bachelor’s Degree in Science or a related field; advanced degree strongly preferred
- 12+ years’ experience in the pharmaceutical or biotechnology industry in a quality or compliance
- 2+ years experience as a functional head of a quality department
- Strong GxP knowledge in the pharmaceutical industry
- Hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)
- Proven record of developing and maintaining successful working relationships with regulatory agencies