Provides theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area. Independently plans and executes most unit operation characterization and optimization experiments within expertise and develops an awareness of unit operations in other areas. Responsible for significant or sole technical leadership within project or complex study. Prepares technology transfer documentation and regulatory documents or coordinates with team members to ensure execution. Represents line functions on GCT teams as appropriate/necessary. Proactively identifies process or study issues/challenges and proposes potential resolutions.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Line Function Specific Qualifications:
Biologics - Purification:
- Hands-on experience with the development and scale-up of purification processes and the use of bioseparation equipment;
- Familiarity with large-scale protein purification;
- Knowledge of design of experiments principles and statistical analysis techniques;
- Familiarity with regulatory expectations relevant for protein purification processes;
- Experience with standard analytical assays.
- Detailed knowledge of writing and editing Unicorn programs
- Experience in packing and evaluating chromatography columns
- Skill with Protein A capture, depth filtration and continuous centrifugation
Education and Experience:
- Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience
- Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience
- PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ years relevant industry experience
- Bachelors or Masters: Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP s
- Sound knowledge of current Good Manufacturing Practices (cGMP)
- Previous experience with the use of contract facilities
- Experience in working in a multi-disciplinary team environment
- PhD: Demonstrated mastery of subject or area related to field
Knowledge and Skills:
- Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions
- Teamwork -- Ability to work well in highly cross functional team environment and across global line functions.
- Communication Skills -Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of internal technical documents
- Organization Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously
- Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
- Resource Management -Ability to manage one s time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
- External Involvement Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events
- Technical - Subject matter expertise and knowledge of applicable lab equipment and operations
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