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Manager, Supply Chain and LogisticsTechnical Operations | South San Francisco, CA, United States
The purpose of this role to provide leadership and management of staff in the planning and execution of Supply Chain activities. The position is also expected to lead Supply Chain related projects teams. The candidate must be accomplished and experienced with the applications of supply chain operations and as an expert in the field. The candidate will lead the Supply Chain staff in the innovation and development of Onyx business processes. The position is also expected to lead Supply Chain related projects teams and actively participate and support clinical study execution teams in all matters related to drug supply. This position will oversee clinical contract manufacturing, clinical packaging, labeling and distribution operations as needed. Responsible for developing business processes supporting the creation of an effective distribution and logistics structure for Onyx.
Essential/Primary Duties, Functions and Responsibilities:
* Leads Supply Chain group to execute supply to patient including: Develop and maintain transportation structure for Onyx’s products. Manage distribution networks and logistics and transportation activities for all material types – raw and starting materials, drug substance and drug product, finished product. Manage execution of global clinical studies, from forecasting through drug packaging, labeling, distribution, returns and destruction. Interface with Clinical Operations and Regulatory Affairs on all information required for Health Authority Submissions and study set up and maintenance.
* Develop and maintain formal process to manage temperature excursions and manage Quality Systems required documentation, including Deviations and Investigations, Change Controls, Label and Product Specifications, and others as required.
* Manage vendor selection for clinical study support, focusing on carrier and distribution networks as well as other clinical supply related vendors as required. Work with Regulatory Compliance and QA as required in selection/qualification of CMO''s. Work with stakeholders & legal support to negotiate effective supply/technical agreements.
* Identify business improvement opportunities and implement business processes related to the Clinical Supply Chain and Distribution and Logistics area.
* Coaching and mentoring Supply Chain staff.
* Other activities as uirements
* BA/BS with15+ years experience.
* MBA with 12+ years agement of Staff:
* 3+ years management experience ctional/Technical Knowledge & Skills:
* Strong knowledge and understanding of Pharmaceutical Supply Chains.
* Strong knowledge and understanding of cGMPs.
* Business Process or Operational Excellence 5+ years.
* Experience preparing business processes.
* Influence group or department on business process decisions.
* Technical Experience (API or Drug Product) 10+ years.
* Previous experience in API or Drug Product Research, Development, Analytical, Manufacturing or Supply Chain.
* CMOManagement (8+ years)
* Prepared requests for proposals and statements of works.
* Negotiate agreements with Clinical CMOs (> $5 million in value).
* Lead and drove the selection process for selecting early and late stage Clinical CMOs.
* Project Management or People Management tomer & Industry Knowledge:
* Experienced in Supply Chain operations and the application of cGMP principles. Function as Onyx representative at Contract Research/Manufacturing cation/Training:
* At minimum BA/BS in business or technical er Requirements:
* Lead Teams with Manager level team members.
* Influence at Manager and Sr. Manager level team members.
* Business Process Thought Leader at Onyx (Within Supply Chain).
* People management skills.
* Contract Preparation experience.
* 25% Travel petencies:
Experience with global distribution and logistics, hazardous material transport, carrier selection and management.
* Strong knowledge and demonstrated practice of ICH/cGXP Guidelines.
* Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships.
* Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure.
* Motivated, self directed, able to work autonomously and have a proven ability to work in a team environment.
* Proficient in Microsoft Outlook, Word & Excel
* Must be highly organized and possess excellent attention to detail.
* Must have strong oral, written and interpersonal communication skills.
* Experience with regulatory submissions is a plus.