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AQC Group Leader/ Scientist II *LOCATED IN GENEVA, SWITZERLAND*
Durham, NC
Job Description
IMPORTANT: This position is located in GENEVA, Switzerland
Job Summary
This position will act as AQC group leader, responsible for independent problem solving. Execute components of a project. Focus on meeting deliverables
Job Responsibilities
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Job Summary
This position will act as AQC group leader, responsible for independent problem solving. Execute components of a project. Focus on meeting deliverables
Job Responsibilities
- Supports product development efforts in the process, formulations, and analytical development areas. Conceptualizes and proposes process development, formulations
- development and analytical development strategies based on biopharmaceutical data.
- Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements.
- Works toward developing a broad knowledge of state-of-the-art principles and theory; may
- provide technical leadership in the group, may serve as in-house advisor on key scientific discipline areas.
- Hands-on cGMP manufacturing and provide technical support for clinical manufacturing and product testing.
- May be called upon (as a development assignment) to be a project team leader of a development program that includes the following duties:
- Direction and administrative duties including the coordination of efforts of team members and across departments;
- Acting as spokesperson on development programs and interact positively and productively with clients·
- Advising, management of program status
- Responsible for the management and professional development of lower level Scientists and associates; orient new employees as to the organization and department policies, and what results are expected of them. Review their position responsibilities with them.
- Communicate and administer procedures for the area in accordance with approved policies.
- Responsible for producing publications and for presenting selected papers at conferences.
- Identify potential inventions arising from work and support development of patent applications.
- Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements.
- Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
- Able to react to change productively and handle other essential tasks as assigned.
Minimum Requirements
- B.S. degree and 9 years of related experience; M.S. and 7 years of related experience or Ph.D. and 2 years related experience in a scientific discipline.
- Records (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, GCP, and/or by co-workers to understand situations and to perform their assignments.
- Prepares documents using own and others' data; organizes, clarifies, and presents information for internal and external audiences using commonly available software such as MS Office.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.
- Understands and applies mathematical concepts and methods; interprets data and results using quantitative measures and statistical analysis.
- Performs and documents calculations and conversions as part of standard processes; develops tests and methods to assure accuracy of processes and measures.
- Learns and applies new quantitative concepts; performs calculations to diagnose or trouble-shoot.
- Fluent in English, French desirable
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Job Summary
Company
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
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