Scientist, Biologics Analytical Development
Involved in analytical method transfer and qualification/validation at CROs/CMOs. Oversees analytical results to support GMP production. Reviews and/or authors the CMC sections of regulatory filing documents. Oversees the activities at CROs for advanced characterization. May perform analytical method development/optimization and phase appropriate qualification. May conduct product characterization of recombinant proteins and conjugated proteins derived from microbial and/or mammalian expression systems. May characterize protein molecule and complex protein conjugates using various analytical methods, i.e. HPLC, CE, mass spectrometry, Biacore, etc. Provides analytical support for upstream and downstream process development. May participate in the development of patent applications. This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
Essential Duties and Responsibilities:
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments. Synthesizes multiple data sources and draws general, non-obvious conclusions. Defines problems, develops approaches and develops experiments with sound judgment with minimal supervision. Uses professional concepts and scientific knowledge to contribute to the development of company concepts and principles to achieve objectives in creative and effective ways. Interfaces with various departments and partners. Plans and coordinates activities with other team members. Writes and/or approves complex reports and protocols. Maintains knowledge of regulatory compliance requirements. May assist with implementing organizational systems, identifying capital equipment, and projecting resource requirements. May lead staff or a group, provides training as needed, and ensures adherence to company policies and quality requirements.
Minimum Qualification Requirements:
A PhD in a scientific or engineering discipline is required. Equivalent experience may be accepted. A minimum of 2 years work experience in a biotechnology/pharmaceutical industry, preferably in a process development, is required. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought. Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment. Excellent written and verbal communications and teamwork skills are essential. Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work. Must possess good oral and written communication skills. Ability to present technical information to both technical and non-technical audiences is required. Must be able to demonstrate sound judgment. Must be able to demonstrate problem solving capabilities. Strong organizational skills are required. Good computer skills are required. Working knowledge of MS word, Excel, Power point is required. Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are a plus. Experience with regulatory filings is a plus. Previous management skills are a plus. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills.
Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function.