Director CMC Operations
Abarca Health- Full Time
- Senior (5 to 8 years)
Candidates should possess proven leadership in applied qualitative research, COA development, and COA validation, demonstrating a passion for quality and continuous scientific innovation. They should have a robust understanding of the global regulatory landscape and associated requirements, with the ability to navigate regulatory complexity, and extensive experience in consulting, focusing on understanding and addressing client needs with carefully selected scientific solutions. Strong interpersonal, organizational, communication, and staff management skills are also required.
The Qualitative COA Lead will manage and grow an established team of scientists, defining the COA qualitative offering, championing thought leadership, driving process innovations, collaborating with the commercial team on business development strategies, serving as a point of contact for clients, planning team capacity, staffing opportunities, offering development opportunities for team members, leading recruitment activities, managing the team pipeline, driving financial success, and ensuring operational excellence. The lead will also support client projects as a scientific advisor and/or principal investigator, working with PCR leadership and other stakeholders to develop a vision for thought leadership, innovation, marketing, and business development strategy, coordinating responses to client RFPs, identifying business risks and developing mitigation plans, and providing clients with advice on COA strategy and appropriate scientific solutions.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.