This position is responsible for the procurement of custom synthesis of APIs for preclinical and clinical development of new pharmaceutical products and commercial products.
Responsibilities will include, but are not limited to, the following:
Manages outsourced manufacturing activities for manufacturing of active pharmaceutical ingredient (API).
Ensures suitable quality, optimal economics, and adequate supply chain security for API for commercial and clinical products.
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Ability to study and apply API physical and chemical characteristics in formulation development.
Identifies and purchases custom raw materials, and supplies necessary for the operation of a pharmaceutical and chemical manufacturing organization.
Confers with contract vendors and analyzes vendors' operations to determined factors that affect prices and determines lowest cost consistent with quality, reliability, and ability to meet required schedules.
Reviews proposals, negotiates prices, selects or recommends suppliers, analyzes trends, follows up orders placed, verifies delivery, approves payment, and maintains necessary records.
Ensures all regulatory requirements are met in the Technical Operations and Contract Manufacturing Facilities
Assists and/or lead transfer of new technology from Process R&D to Manufacturing Facilities for commercial and development compounds
Coordinates production schedules based on clinical requirements.
Works on process and chemistry problems of moderate complexity where analysis of situations or data requires an evaluation of intangible variables.
Assure timely delivery of adequate supplies of APIs and precursors to meet project needs and
identify and qualify sources of starting materials, intermediates, and APIs
Coordinate the establishment of suitable agreements covering confidentiality, supply terms & conditions, and quality agreements
Collaborate with other functions in performing effective inter- and intra-company technology transfers
Monitor and troubleshoot key manufacturing activities via teleconferences and site visits
Timely communicate risks and delays to project teams
12 years relevant experience in a related field, including 4 years of leading role in manufacturing, planning, or outsourcing in the pharmaceutical industry.
BS/MS degree in science, engineering (chemistry or chemical engineering degree preferred) or business
A PhD degree may be substituted for 3 years of related experience.
In depth understanding and application of principles, concepts, practices, and standards along with an in depth knowledge of industry practices.
Able to develop solutions to moderately complex problems, which require the regular use of ingenuity and innovation
Solid understanding of physical and chemical interactions of API in dosage forms development.
Strong negotiation skills
Exceptional verbal and written communication skills
Sound organizational and time management skills
Ability to effectively manage multiple priorities and projects.
Strong knowledge of GMPs API manufacturing and associated regulations
Ability to interact effectively with senior management