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 a Senior Analytical Scientist, 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. Work is highly independent and requires an on-site presence in the office.

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.
• Conduct review of peer data.
• 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) in the field on one or more complex analytical techniques used at AMPAC. Speaks at conferences on analytical technologies on behalf of 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.
• Takes on leadership activities for small and large teams with minimal guidance from Team Leads and Management

EDUCATION AND EXPERIENCE

• PhD, M.S. or B.S. in biochemistry, analytical chemistry, biotechnology, pharmaceutical sciences, or related areas
• PhD (3+ years)/M.S (5+ years)/B.S. (8+ 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 method development, optimization, and validation for pharmaceuticals
• 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
• 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.

• 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.
• Conduct review of peer data.
• 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) in the field on one or more complex analytical techniques used at AMPAC. Speaks at conferences on analytical technologies on behalf of 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.
• Takes on leadership activities for small and large teams with minimal guidance from Team Leads and Managemen