Manager, Regulatory CMC
Orca BioFull Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Candidates must possess a B.S. in Chemical Engineering, Biochemistry, Biology, or a related field with over 10 years of experience, a Master's degree with over 8 years of experience, or a Ph.D. with over 5 years of experience. A minimum of 10 years of related experience in the Pharmaceutical Industry or an equivalent life science field is required, along with experience in the biopharmaceutical industry, service industry, bioprocess development and/or manufacturing, or other science-based industries in biologics, and downstream process development. Strong customer-facing experience, comprehensive expertise in pharmaceutical development, manufacturing, and outsourcing with an emphasis on Good Manufacturing Practices, proficiency in Microsoft Office applications, strong leadership and conflict resolution skills, in-depth knowledge of functional area, business strategy, and company goals, decision-making capabilities, and the ability to act as an agent of change are essential. Excellent interpersonal and engagement skills, talent management, team building capabilities, and the ability to collaborate with internal and external senior-level executives and across Business Units are also required.
The Manager, Scientific and Technical Affairs will serve as a Biologics Subject Matter Expert for proposal development, timelines, and customer technical discussions. They will work closely with the commercial sales team to provide scientific support on sales calls and present technical capabilities at meetings, conferences, seminars, and roadshows. This role involves supporting business management as a technical point of contact and customer service representative for Biologics business projects, and collaborating on the development and commercialization of new business offerings. The position also requires supporting Marketing in the development of technical content such as whitepapers and presentations, and collaborating with Biologics GMP sites to align process and analytical platforms with manufacturing capabilities and business strategy. The role is responsible for driving annual revenue for the Bio division within the Biologics Business Unit, supporting the optimization of the production process to increase project savings while maintaining cGMP compliance, and developing and completing technology development initiatives and strategies with a focus on process development.
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.