Description
- On extremely unique and complicated projects, the Staff Scientist explores, develops, and verifies new scientific approaches used to manage raw materials, production intermediates, and final products, with a bioanalytical focus.
- Staff Scientist will work on protein and large molecule drug development in the pre-clinical, clinical, and/or post-marketing stages.
- Through wide knowledge, the Staff Scientist works on major technical/scientific project activities to execute strategies and technical solutions that satisfy client goals and expectations.
- Participates in technical talks with clients, which necessitates a high level of technical expertise in large molecule pharmaceutical development.
- Creates procedures and equipment designs for clinical, scale-up, and/or registration batches, as well as transferring project technology to and from clients.
- With leadership and independent judgement, evaluates and contributes to the design of manufacturing processes, and supports problem solving as needed.
- Working in a specialized scientific domain, such as bioanalytical development, cell culture, protein purification and characterisation, process validation, formulations, and/or manufacturing technical support is typical.
- Makes decisions that frequently require developing new options to solve complex problems.
- Develops scientific strategy in collaboration with top department and division executives.
- Leads strategic initiatives and solutions.
- Works closely with site management to ensure that client and site criteria are met for a portfolio of projects.
- Responsible for the creation and coordination of realistic proposals and timetables. Leads client meetings and teleconferences.
- Leads the creation of procedures and processes that meet or exceed customer expectations, as well as providing critical innovation.
- Conducts industry research and applies findings to creative medicine development both internally and for client products.
- Leads a team on several projects; supervises project timetables and deliverables for the team; and may analyze the financials of the group.
- During the introduction of new procedures and processes, provides guidance and advice.
- To accomplish project and team objectives, communicates with internal scientific, analytical, and laboratory functional domains.
- All duties are carried out in strict accordance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety regulations.
Qualifications
- Bachelor's of Science in Chemistry, Biochemistry, Biology, or related life sciences field. PhD preferred
- Typically requires 12 years of progressive scientific experience, including 9 years in a related life sciences field. If related Master's degree, typically requires 10 years of related experience. If related PhD, typically requires 6 experience. Experience working directly with clients.
- Advanced understanding of different aspects of a discipline's principles, concepts, and practices, as well as expanding knowledge of principles and concepts in other related fields. Expert understanding of scientific methods and advancement in the pharmaceutical sector.
- Good Manufacturing Practices (GMP) expertise.
- Strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills, as well as statistical analysis.
- Superior ability to think critically and logically.
- Management of technical discussions with internal and external clients, as well as effective written, interpersonal, and presenting abilities.
- Ability to manage numerous projects at the same time.
- Ability to learn and practice pharmaceutical processes, equipment, instrumentation, and procedures.
- Ability to keep up to date on scientific literature and industry trends relevant to process technologies and retain specialist knowledge.
- Technical problem-solving ability.