Analytical Scientist III

In this role you will apply your expertise in a range of small molecule analytical techniques to provide technical design, leadership and execution of method development and validation activities for various drug substances and drug products. As an Analytical Scientist III, you will ensure analytical tasks and methods are suitably qualified/validated for use in GxP laboratories, support filing activities, as well as being heavily involved in the company's overall commercial strategy. Works under only general direction. This position is not remote.

DUTIES and RESPONSIBILITIES:

• Executes method development, implementation, validation, and transfer protocols and procedures to support the analytical team using HPLC, GC, KF, and a variety of other instruments and techniques
• Drafts method validation and transfer protocols for execution in the analytical team
• Analysis of bulk chemicals and pharmaceutical compounds which require a comprehensive knowledge of chemistry and laboratory techniques, in a quality GMP environment. This may also include qualification of primary and secondary reference material to be used as analytical standards.
• Compilation of data obtained from analytical tests and validation, analysis of the data, and drafting reports summarizing results
• Conducts peer review of data including laboratory notebooks, forms and through various laboratory software systems
• Conducts peer review of reports before issuance to customers and stakeholders
• Drafts and reviews methods used for testing in analytical and QC laboratories.
• Write Quality Control Reports (QCRs) documenting deviations and laboratory events and assessing corrective and preventative actions.
• General housekeeping including maintaining general cleanliness of laboratories and restocking reagents and laboratory consumables.
• Develop methods for routine and novel analytical techniques using prior knowledge and literature
• Demonstrates strong Good Documentation Practices (GDP)
• Draft specifications for testing raw materials, in-process control, intermediate and final product compounds
• Leads changes in documentation and systems via the change control process, including revision of documentation, justification for change, risk assessments, and tracking approvals
• Responsible for leadership of analytical project(s) including tracking scope for analytical team and cross-functional coordination with other teams including Research and Development, Quality Control, Operations, and Project Management.
• Is a subject matter expert (SME) on one or more complex analytical techniques used at AMPAC
• Serve as a mentor for quality control and analytical team members, providing technical guidance on analytical technologies and troubleshooting
• Involved in interfacing with customer at times, including communicating results and status, providing technical guidance and strategy for projects
• Participate in integrated product team (IPT) meetings, providing updates on status of methods, specifications, and other analytical activities.
• Lead investigations of laboratory samples and development samples and help determine appropriate corrective and preventive actions (CAPA) to address mitigation of investigation assignable cause.
• May take on leadership activities for small teams with guidance from Team Leads and Management

May perform other duties as assigned

EDUCATION AND EXPERIENCE:

• PhD, M.S. or B.S. in biochemistry, analytical chemistry, biotechnology, pharmaceutical sciences, or related areas
• PhD (1+ years)/M.S (3+ years)/B.S. (5+ years) in a GxP pharmaceutical environment, primarily focused on analytical method development and validation.

COMPETENCIES / SKILLS:

• The successful candidate will have in-depth knowledge and experience of a range of analytical techniques acquired in pharma or CRO/CMO industries for small molecules. Experience with other platforms including oligonucelotides, peptides, and gene therapy is advantageous.
• Experience in mass spectrometry, including ESI,EI, and MALDI ionization with a range of mass spectrometer designs (Q-TOF, Orbitrap, QQQ etc.), and standard chromatographic techniques (HPLC/UHPLC/IEC) and detector
• Experience in method development, optimization, and validation for pharmaceuticals
• Strong background in GxP laboratory environment and regulations
• Good judgement and an understanding of chemistry theories and concepts.
• Must have a high consciousness for personal and laboratory safety.
• Strong attention to detail.
• Strong interpersonal and verbal communication skills.
• Team Oriented.

CERTIFICATIONS and LICENSES

• Not Applicable

This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time