Associate Director, Business Operations/Sourcing Job
Celgene Corporation - Berkeley Heights, NJ

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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 in late stage development and commercial stage of new pharmaceutical products.

Responsibilities will include, but are not limited to, the following:
o Develops business operations, and maintains a scalable and sustainable outsourcing process and workflow within API Tech Services and (drug product) with partner areas to enable compliance, speed, flexibility, and consistency of practice.
o Manages the overall business relationship to secure sourcing of drug substance (and drug product) late stage Development for small molecule and biologics and commercialization support for outsourcing portfolio, including:
o Develops and maintains an appropriate pool of CMOs and partners to respond to current and anticipated external contracting needs for API Tech Services, GMP 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 API Tech Services activities and associated Analytical activities on projects, including:
1.Develops documentation of technology packages for vendor bids.
2.Leads CMO assessment and selection, including review of proposals, and negotiation of prices and terms.
3.Provides oversight and project management of external activities, including preparation of GMP API supplies, and concurrent generation of process knowledge and technical information. Includes oversight of budget, timeline, and deliverables.
4.Verifies delivery (including material, appropriate documentation, and knowledge transfer), and approves payment.
5.Builds and maintains strong working relationships API Tech Services, other areas of Technical Operations, and other partner groups (Pharmaceutical Development, Discovery, etc.) to achieve effective collaboration and execution on program activities.

Requirement:
  • B.S. degree in Life Sciences Engineering. MBA preferred.
  • 10+ years of experience in the pharmaceutical industry preferably with significant experience in Process/Technical Development and managing global contract manufacturing networks and 3rd party relationships.
  • 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.
  • Displays strong analytical and strategic thinking.
  • Demonstrates the ability to negotiate effectively with diverse constituencies to achieve goals.
  • Strong demonstrated people leadership and management with experience in hiring, training and developing outstanding talent and ensuring robust succession planning. Greater than 5 years’ experience managing direct reports and cross-functional, global teams.
  • Effective cross-functional collaboration skills with proven ability to build and maintain strong and sustainable relationships with cross-functional, cross-cultural project teams, internal and external customers, and business partners.
  • Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill-sets to create, influence and negotiate win-win solutions.
  • Strong business and functional knowledge of the disciplines involved pharmaceutical and/or pharmaceutical process development and manufacturing with specific technical experience in biologics DS or DP process development / manufacturing, or analytical development / quality control.
  • Experience developing, negotiating and administering clinical or commercial contract manufacturing / supply and/or quality agreements.
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-MR1
Qualifications
  • B.S. degree in Life Sciences Engineering. MBA preferred.
  • 10+ years of experience in the pharmaceutical industry preferably with significant experience in Process/Technical Development and managing global contract manufacturing networks and 3rd party relationships.
Req ID: 14001791
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: No
Job Posting: 2014-09-15 00:00:00.0

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About this company
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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.