Director – Outsourcing, Drug Substance Development Job

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Date: Jun 20, 2014 Location: Berkeley Heights, New Jersey, United States Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. This position is responsible for sourcing activities for active pharmaceutical ingredients (APIs) and intermediates for preclinical and clinical development of new pharmaceutical products. Responsibilities will include, but are not limited to, the following: • Develops, operationalizes, and maintains a scalable and sustainable outsourcing process and workflow within Drug Substance Development and with partner areas to enable compliance, speed, flexibility, and consistency of practice. • Manages the overall Drug Substance Development outsourcing portfolio, including: o Develops and maintains an appropriate pool of CMOs and partners to respond to current and anticipated external contracting needs for drug substance development, GMP/GLP production activities, and associated analysis and release activities. o Establishes and manages suitable master service agreements (MSAs) and specific contracts with the Drug Substance Development CMO pool (within the context of broader Celgene relations with the CMO) to cover IP protection, supply terms and conditions, and quality agreements. o Builds and manages vendor relationships to ensure productive and high-functioning working relationships with external partners. • Responsible for oversight and coordination of external Drug Substance Development activities and associated Analytical activities on projects, including: o Develops documentation of technology packages for vendor bids. o Leads CMO assessment and selection, including review of proposals, and negotiation of prices and terms. o Provides oversight and project management of external activities, including preparation of GMP or GLP API supplies, and concurrent generation of process knowledge and technical information. Includes oversight of budget, timeline, and deliverables. o Verifies delivery (including material, appropriate documentation, and knowledge transfer), and approves payment. • Builds and maintains strong working relationships across Drug Substance Development, other areas of Pharmaceutical Development, and other partner groups (Discovery, Technical Operations, etc.) to achieve effective collaboration and execution on program activities. • Serves as a member of the Drug Substance Development Leadership Team and is a key technical and business leader for DSD and Pharmaceutical Development. With direction from senior management, guides the department in successful and efficient execution of department/area goals, and continued strategic capability development/improvement. Leadership and Management • Reinforces Celgene culture and values, and drives change where needed to increase alignment with those goals. • Identifies departmental needs and recruits/hires/promotes personnel as appropriate. • Develops staff through coaching, training, and other relevant experiences. Builds high performance teams. • Manages a group of 1 to 4 direct reports. Project and Portfolio Management • Operates effectively in a multi-tasking, cross-functional environment. • Develops appropriately proactive resource plans and utilizes staff and other resources effectively to meet area and partners’ needs. Uses appropriate tools to regularly review, measure, modify, and adjust plans and to monitor the efficiency, effectiveness and balance of resources according to evolving business needs and environment. • Guides internal/external debate and discussions at high levels and focuses constituents towards resolution around strategic and tactical decision making. • Models good decision making practices and assesses and rewards behaviors consistent with good decision making practices. • Displays strong analytical and strategic thinking. Negotiation and Influence • Demonstrates the ability to operate effectively to influence direction and activities in areas outside of his/her direct reporting line. • Demonstrates the ability to negotiate effectively with diverse constituencies to achieve goals. People Management • Provides constructive and timely feedback and coaching to enhance personnel performance. • Coaches employee on long term career development and leadership capabilities. • Guides the reallocation of roles and responsibilities across team members to facilitate both goal achievement and personal development. • Guides and coaches others in managing through change. Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. *LI-KM1 Qualifications Skills/Knowledge Required: • BS (minimum) or MS/PhD (preferred) in Chemistry, Chemical Engineering, or closely related discipline. • Minimum of 10 years experience in the pharmaceutical industry in small molecule drug substance development, scale-up, and technology transfer. Fluency with chemistry and engineering considerations across typical drug substance unit operations, processing, and analysis. • Experience with technology transfer and project management for small molecule APIs and intermediates at CMOs • Working knowledge of related aspects of the overall pharmaceutical development and commercialization process. • Understanding and application of cGMPs and current regulatory standards in API manufacturing for global clinical programs. • Excellent written and verbal communication skills, collaboration, negotiation and influence skills. Req ID: 14001001 Primary Location: United States-New Jersey-Berkeley Heights Job: Manufacturing Organization: Celgene Corporation Schedule: Regular Shift: Standard Employee Status: Director Job Type: Full-time Job Level: Day Job Travel: Yes, 10 % of the Time Job Posting: 2014-04-21 00:00:00.0
Phama Job Categories: 
USA
Manufacturing

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