The Team Lead, Analytical performs analytical chemistry assignments requiring a wide application of advanced principles, theories, and concepts. With little to no guidance, this position coordinates the short term and long-term activities across a variety of challenging analytical projects to support both business and production operations. Directly supervises individual contributors.
Duties and Responsibilities:
Will be directly responsible for all aspects of analytical development, validation, methods and specifications for multiple projects. Will be involved in direct customer interactions. May require customer visits to discuss analytical methods transfer and validation.
Will be responsible for leading a team of 3-6 chemists and assign work to them and direct projects as required.
Will be responsible for creating time lines to assure completion of transfer, development, and validation of methods to meet customer requested date.
Drafts method validation and transfer protocols for execution in the analytical team. 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.
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.
Participate in integrated product team (IPT) meetings, providing updates on status of methods, specifications, and other analytical activities.
With little to no guidance, leads projects of significant scope and/or impact to AMPAC.
Lead investigations of laboratory samples and development samples and help determine appropriate corrective and preventive actions (CAPA) to address mitigation of investigation assignable cause.
Suggests and leads continuous improvement initiatives that impact the larger AMPAC quality organization.
EDUCATION AND EXPERIENCE
Bachelor's degree in chemistry or an appropriate science.
3-5 years directly related technical experience or equivalent combination of education and experience.
3+ years of supervisory experience.
Requires knowledge of cGMP/GLP regulations.
COMPETENCIES/SKILLS
Ability to communicate clearly and concisely both orally and in writing.
Good understanding and experience of chemical laboratory process and equipment, specialized analytical equipment, and various computer systems.
May be recognized as the subject matter expert (SME) in an advanced analytical technique.
Must be proficient with the use of general laboratory software and CDS systems.
Must be proficient with the use of LC, GC, NMR, HSGC (including various applications of these techniques), in addition to other simpler analytical procedures.
Must have knowledge of cGMP related to the analytical testing for an API manufacturer.
Understand and use of process and analytical equipment pertinent to the appropriate application of skills.
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
