Associate Director, Pharmaceutical Technology

Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options.

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. The primary role of this position is to lead, manage, and coordinate internal and outsourced drug product manufacturing processes for Celgene pipeline products. This position will play a central role in the planning and execution of projects to advance the development of the Company’s product candidates. Products may be at later phases of development or at commercial scale. The position is also responsible to transfer products to manufacturing sites as required.

* Provide operational leadership for process scale up and improvement programs. * A thorough understanding of drug product and process technologies is required. * Multiple programs will be operational at the same time therefore time management and the ability to multitask are considered critical job responsibilities. * Approximately 70% of the actual work will be performed by contract manufacturing organizations under the direction of this position. Therefore, strong communication skills and the ability to appropriately represent Celgene are required. * Provide feedback on formulation and process feasibility * Define, develop and implement pharmaceutical process strategies based on scientific, technical, regulatory, and market place needs * Develop project plans which define timing, resources and overall project costs * Evaluate, recommend and oversee contract manufacturing organizations (CMO) capable of providing the technical services required. Provide financial and administrative oversight on CMO’s * Act as the primary representative to internal and external clients for dosage form process scale-up * Lead, guide, and direct in executing process optimization, and validation studies * Lead the resolution of technical issues related to products in development or in commercial. * Coordinate project activities with other internal functions such as Regulatory Affairs, Quality Assurance, Analytical R&D, Sales/Marketing, etc. * Author, review and approve CMC related documentation as required for the market application * Interact with FDA/EMA regulatory authorities as required * Responsible for Change Control and CAPA’s * Partner in continuous improvement projects. Contribute to department goals

**Qualifications:** * Broad based knowledge of pharmaceutical manufacturing * Background in drug process development with demonstrated expertise in solid dosage forms, and drug delivery technologies. Should be familiar with semi-solid, and liquid dosage forms * Understand impact of drug substance on drug product performance * Ability to evaluate, and share data across functions for evidence based decision making * Proven ability in pharmaceutical process scale-up and improvements * Lead, and participate in technology transfer activities * Lead Scale-up and Process Validation activities * Strong communications skills with a team oriented approach * Project Management skills including the ability to prioritize, schedule and manage multiple projects and resources simultaneously * Working knowledge of international GMP requirements and quality systems * Working knowledge of current regulatory guidelines (EMA and FDA) **Requirements & Education:** * A Ph.D. in pharmaceutical science, chemical engineering, or related discipline with a minimum of 11 - 13 years of relevant industry experience or a MS or BS degree with 16 years in pharmaceutical processes. * This individual must be highly motivated and enjoy working in a fast paced, challenging matrix environment. * The individual should be able to interact cross-functionally at all levels internally within Celgene, and externally with consultants/contractors and business partners. * The candidate must be flexible relative to responsibilities. Approximately 30% to 40% travel, both domestic and international, is required.