Associate Director / Director, Technical Operations Cytokinetics
THIS JOB HAS EXPIRED Description:
Cytokinetics, Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Working collaboratively, Cytokinetics? devoted and passionate personnel are focused on advancing novel therapeutics to dramatically improve the lives of patients. With purpose and passion, we have committed to make an important impact on serious medical illnesses.
Responsibilities will include management of all drug manufacturing activities by working with contract manufacturers. Serve as a focal point for manufacturing operations with management, and with all internal and external customers and stakeholders to assure that manufacturing issues and project timelines within a project are addressed in a timely, superior and consistent manner, which meets all customer requirements and business needs. Assure all outcomes are in compliance with established regulatory and corporate requirements. Assure/secure appropriate resources and systems for effective coordination within the Supply Chain to demonstrate excellence, in quality, cost and customer service. Maintain a sense of urgency to ensure continuity of product supply. Extend manufacturing capabilities, strategies and technology. Establish metrics to measure supplier performance. Manage contract manufacturing audits via partnerships with the Quality Assurance organization. Meet regularly with contractors and suppliers to develop communication and understanding between parties. Manage changes related to contract manufacturing domestically and internationally facilitating and maintaining quality agreements from initial proposal to successful implementation. Contributes to a motivating work environment, where superior performance is defined, supported, rewarded and recognized. Ensures on-going performance dialogue, relationship building and contractor mentoring. Establishes objectives and specific action plans that support performance metrics. Communicates quality and business activities, trends, and decisions in a timely manner. Recommends meaningful rewards for superior contributions to our quality and business operations.
o PhD, MS or BS in chemistry, pharmaceutics or a related discipline; advanced degree preferred.
o 10+ years manufacturing experience in biotech/pharmaceutical industry.
o 5+ years Operations Management experience in a drug product manufacturing.
o Expertise in various aspects of pharmaceutical operations e.g. CMC, QA/QC, validation, engineering, logistics, drug process development, submission docs, IND, API, product specs, pre-clinical development, sterile manufacturing.
o Understanding and management of the clinical supply chain process, including packaging and labeling functions.
o Experience working with CMOs throughout the globe.
o Demonstrated working knowledge of cGMP and applicable regulatory requirements.
o Demonstrated organizational and leadership skills; advanced computer knowledge and skills, written and oral communication skills
o Expertise managing cross-functional teams, project facilitation
o Demonstrated ability to complete projects on time with expected benefits.
o Demonstrated ability to forecast and manage budgets
o Ability to analyze resource commitments, project success criteria and other key indicators to provide interventions/adjustments as needed.
o Builds constructive, trusting, and respectful relationships with people at all levels within and outside the organization.
o Demonstrates a commitment to excellence by delivering measurable results that equal or exceed stretch targets.
o People management and development experience required.
||South San Francisco, CA |
THIS JOB HAS EXPIRED