Provides theoretical/conceptual input to the design, development and execution of assignments for a specific project or projects within the functional area. Independently plans and executes most unit operation 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 technical documentation and regulatory documents or coordinates with team members to ensure execution. Represents line functions on CMC teams as appropriate/necessary. Proactively identifies process or study issues/challenges and proposes potential resolutions.
The ideal candidate must have strong technical knowledge and experience in Biologics QC requirements, including, but not limited to the following, Cation-Exchange Chromatography (CEX), Capillary Isoelectric Focusing (iCEF), SDS-PAGE, Capillary electrophoresis- SDS (CE-SDS), Size Exclusion Chromatography (SEC), Binding Efficacy, cell-based bioassays, ELISA, Residual CHO DNA by qPCR, RP-HPLC, Gas Chromatography, Karl Fischer titration, UV Spectrophotometry, FTIR, Protein concentration by UV spectrometry, sub-visible particles testing by light obscuration/microscopy, Endotoxin LAL, Sterility, and Bioburden. The candidate must also have a solid understanding of Quality Control CMC requirements for Biologics IND, BLA, and other global regulatory filings. A Strong working knowledge of QC and GMP compliance. Proficiency with electronic documentation (such as LIMS, learning management system, excursions management system). Proficiency in stability data trending using statistical tools. The candidate must have a solid understanding of Quality Control CMC requirements for Biologics IND, BLA, and other global regulatory filings.
- Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
- Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks.
- Contributes significantly and independently to project work which may include multiple projects within functional area.
- Reviews, interprets and communicates data cross-functionally within CMC and project teams.
- Plans and implements resolutions to technical problems/issues
- Represents functional area on CMC project teams by communicating activities from designated functional area to project team
- Supports local and global initiatives which may include leading initiatives or work streams
- Serves as a technical resource for junior staff and leverages expertise as a functional resource/trainer.
- Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
- Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations
- Proactively identifies and analyses issues and coordinates potential resolution with the CMC or cross functional team.
- Responsible for integrating GMP/scientific/technical efforts around cross-functional issues
- Support vendor audits
- BS or equivalent and 6+ years or Masters level degree
- Minimum 4 years laboratory experience in biotech industry
- Minimum of 3 years in Quality Control and/or Analytical Development.
- Biologics QC experience and technical knowledge including expertise with CMC representation and project management skills.
- Test Management and Controls (Quality Control) - Biologics
- 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 or external 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)
- Technical - Subject matter expertise and knowledge of applicable methods and assays, QC compliance, GMPs and applicable regulations and guidance
- Auditing experience
May require approximately 5% - 10% travel.