SIGA Technologies, Inc. (www.siga.com) is seeking an experienced Director, Analytical Science to lead the analytical function within our expanding Chemistry, Manufacturing and Control (CMC) team in Corvallis, Oregon. As the leader of this functional area, this position reports directly to the Chief Technical Officer and plays a critical role in shaping analytical chemistry strategies to meet company needs. This position oversees the scientific, technical and administrative activities related to analytical sciences of drug development and manufacturing. This full-time (40 hours/week) position is eligible for SIGA's full benefits package including company paid medical, dental, and visions benefits, short and long-term disability, life and AD&D insurance and paid time off. This position is eligible for remote employment within the United States and requires domestic and international travel up to 20% of the time.
Responsibilities for this position include:- Plan, develop, and oversee analytical chemistry projects, Contract Manufacturing Organization (CMOs) and Contract Research Organization (CRO).
- Develop, review and approve analytical method validation protocols, method transfer, reports, stability protocols, stability data, process validation protocol, specifications and test methods.
- Collaborate with other team members from Chemistry, Manufacturing and Control (CMC), QA, regulatory, non-clinical, and clinical functions on analytical matters as necessary.
- Prepare and review analytical related documents for FDA submissions, BARDA communications, internal management reviews, drug substance and drug product production
- Work closely with SIGA's Project Management Team in the reporting of data, study progression, determining and implementing activities for next steps.
- Identify, recommend, qualify CROs, and audit CROs as needed.
- Manage the conduct of analytical chemistry studies carried out by CROs, including review of protocols, reports and data presentations.
- Request and evaluate statements of work for projects including stability studies and analytical development from CROs.
- Compile and present data to internal and external audiences.
- Assist in the preparation of IND, IND amendments, NDA and other types of regulatory filings.
- Review scientific literature to understand current trends in analytical chemistry research, drug discovery, and vaccine development.
- Review FDA guidance to stay current in the expectations and requirements associated with IND and NDA filings.
- Attend regularly scheduled meetings with SIGA's Customer(s), upper management and internal project teams.
- Interface with regulatory agencies, as required.
- Other responsibilities as assigned.
Minimum Qualifications include:- An advanced Degree (Ph.D. or equivalent) in Chemistry or a relevant field with a minimum of 8 years of pharmaceutical industry background in Analytical Chemistry.
- Demonstrated ability to manage the output of Contract Research Organizations including the quality and completeness of data and timely receipt of deliverables according to a pre-determined schedule.
- Expertise with a broad range of commonly used analytical chemistry and microbiological test methods.
- Broad knowledge and experience with regulatory requirements including ICH, FDA and compendia USP, JP, EP.
- Significant experience authoring CMC sections for IND and NDA submission experiences.
- Experience in preparing data for presentations and publications
- Regulatory interaction and government contract experience preferred.
- Familiarity with government-funded projects is a plus
The successful candidate will possess the following knowledge and abilities:- Must be detail oriented and comfortable in a fast-paced, rapidly changing work environment requiring the ability to prioritize and multi-task.
- Able to work independently as well as in groups, and must have excellent oral and written communication skills.
- Must have a thorough understanding of good laboratory practices and their application.
- Knowledgeable of FDA/ICH/EMA guidance in the areas of Analytical Chemistry, cGMP and cGLP.
- Demonstrated ability for critical thinking and innovation
