Specific Job Responsibilities:
- Applies advanced level of understanding of analytical methods.
- Selects appropriate methods and techniques in performing methods development.
- Independently plans and executes experiments that support routine & non-routine development activities and project goals.
- May design new experiments to support development of drug substances and drug products or techniques to test such substances.
- May create API or drug product specifications.
- Generation, review and approval of development & validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
- Collation of data and technical writing for submissions for regulatory filings.
- Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols
- Operates as part of a global sub team as an AO lead
- Recommends alternatives, researches new methods and techniques and may proactively seek out senior personnel to discuss potential solutions to problems.
- Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
- Works independently and determines methods and techniques on new or difficult assignments.
- Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors.
- Acts as a resource for other employees within the department.
- Task management of junior employees may be required
- Manage group with multiple areas of responsibility and may lead a component of a project within the job family.
- Identifies and introduces new technology and/or methods to the organization and trains junior staff.
Skills & Expertise:
- Develops skills in data analysis and ability to evaluate quality of data.
- Maintains high level of expertise through familiarity with scientific literature and applies appropriately to development projects.
- Uses strong communication skills (both verbal and technical) and interpersonal skills to communicate objectives and results.
- Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
- Has scientific expertise and ability to think ahead to the next step in drug development process.
- Working knowledge of GMPs, pharmacopoeial, regulatory requirements for analytical testing, phase appropriate standards for method validation.
- Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
- Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & HPLC proficient in LIMS & Empower etc.
Typical Education & Experience
- 11+ years of experience with BA or BS degree in Chemistry or Biology.
- 9+ years of experience with MS degree in Chemistry or Biology
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