Doctorate degree and 2 years of directly related experience or master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience
- Proficient in the preparation of Deviation / Investigation
- Knowledge in Inspection / Packaging / Devices Process including In-Process Testing preferred Auto-Injectors.
- Computer Skills (Word, Excel)
- Knowledge Statistical Analysis (Minitab)
- Provides advanced data analysis and interpretation.
- Fully Bilingual
To develop projects/programs and contribute to novel experimental strategies and scientific vision. Functions as a lead scientific resource with cross-functional impact. Capable of managing and leading scientific projects which may involve cross functional areas. Guides the successful completion of major programs by either functioning in a project leadership role or as the lead scientific/technical resource. Decisions or recommendations impact the ability to achieve functional /departmental objectives. Provides guidance in the resolution of scientific/technical issues within the function/department. Works independently and integrates activities with other function/department. Exercises considerable latitude in determining objectives or assignments within the function /department. Evaluates progress toward goals and achievement of milestones for work group, with limited additional oversight, may translate evaluation into appropriate action. Anticipates complex technical problems and develops practical an innovative solution.
Frequently develops novel processes or approaches to solve problems within a broad discipline within the work group. Identifies and analyzes factors and trends outside immediate area that impact project or function/department. Frequently introduces or creates new technologies and concepts. Leads teams that contribute to the achievement of department/project/product team objectives. Coaches, motivates and provides career and scientific/technical, advice to colleagues within the function/department. Communicates and/or presents scientific/technical information formally and informally within area of expertise to a diverse set of audiences, including senior management and external scientific community. Applies knowledge of drug discovery and development process to guide functions/departments
Act as scientific/technical expert within the function /department Leads the development of key scientific/technical comments.
Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience or Associate’s degree and 10 years of directly related experience.
COMPETENCIES/SKILLS Working knowledge of pharmaceutical/biotech processes. Familiarity with documentation in a highly regulated environment. Ability to operate specialized laboratory equipment and computers as appropriate. Ability to interpret and apply GLPs and GMPs. Able to develop solutions to routine technical problems of limited scope. Demonstrated skills in the following areas: Problem solving and applied engineering, Basic technical report writing, Verbal communication, Demonstrated Skills in the following areas:
Basic technical presentations, Personal Organization, dealing with and managing change, Technical (Equipment Specific), Analytical Problem Solving, Computer Literacy, Specialized equipment/process expertise, interacts effectively with variety of communication and working styles, Ability to independently determine when additional internal resources are required to solve problems, Ability to handle multiple projects at one time. Demonstrated Skills in the following areas: Schedule development, Facilitation, Collaboration. Completion and follow-up. Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope. Problem solving skills requiring the application of scientific and theory and calculations and creative skills in the development of hypotheses and approach. Working knowledge of financial analysis tools. Ability to delegate and manage the project work of others. Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation, Collaboration, Project cost development, Conflict Resolution, Leadership and teambuilding, Management of contractors and vendors, Knowledge of theories and principles related to leading edge technologies. Advanced (industry level) technical expert in at least one specialty area. Ability to motivate and communicate visions/missions. Demonstrated Skills in the following areas:
Advanced project management. Presentations to large groups. External networking. Personnel coaching and development.