SIGA Technologies, Inc. (www.siga.com) is seeking an experienced to join the team at our location in Corvallis, Oregon. This position will report directly to the SVP of Operations.
The successful candidate will be responsible for the day-to-day management of an expanding Contract Manufacturing Organization (CMO) supply chain and therefore must have experience with external vendor management.
The External Manufacturing Manager will provide Man-in-plant coverage at vendor locations and will work closely with the CMC, Regulatory, Project Management and Business Operation teams.
This position will be expected to travel to vendor locations both domestically and internationally up to 70% of the time.
Description of Duties :
Provides technical expertise in management of a pharmaceutical manufacturing supply chain from drug substance to drug product to packaging and delivery to customer.
Identifies project risks and gaps and works to mitigate those risks.
Communicates effectively and transparently with functional heads within Pharmaceutical Development, Quality, Regulatory, Project Management and Operations.
Communicates effectively and productively with responsible team members from manufacturing partners (CMOs).
Provides on-site support during active manufacturing at vendor locations
Addresses problems and deviations as they arise at the manufacturing sites and assists in implementing corrective and preventative actions.
Prepares and presents documentation for BARDA communications and internal management reviews.
Works closely with SIGA’s Project Management Team in the reporting of supply chain status.
Evaluates CMO performance, reviews batch manufacturing records, deviations and investigations.
Maintains understanding of current trends in drug product manufacturing and engineering research.
Maintains understanding of current FDA guidance related to CMC activities.
Attends regularly scheduled meetings with SIGA’s Customer(s), upper management and internal project teams.
Job Qualifications :
A minimum of five years of pharmaceutical supply chain experience including commercial production
Advanced Degree in pharmaceutics, chemical engineering, chemistry or a relevant field.
Broad knowledge and experience with regulatory requirements including ICH, FDA and compendia USP, JP, EP.
Experience in preparing data for presentations and publications.
Management experience in a pharmaceutical / biotech industry setting.
The ability to function in a fast-paced, high-growth, entrepreneurial environment.
Strong regulatory knowledge of drug development, CMC, preclinical and clinical requirements.
Experience with antiviral or anti-infective drugs a plus.
Travel domestically and internationally will likely be required.
About SIGA :
SIGA designs and develops novel countermeasures to prevent and treat serious infectious diseases, with an emphasis on biological warfare defense.
SIGA is now considered a leading drug development company in the biodefense arena. Its portfolio of existing drug candidates and its platform for developing additional countermeasures against potential agents of biological warfare are intended to fill a critical need for safe and effective treatments.
SIGA offers a challenging, dynamic environment with growth opportunity, competitive compensation, and a full benefits program.
SIGA is an Equal Opportunity Employer.
Interested applicants should submit their resume for consideration to humanresources siga.com.