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 engineering process development activities for synthesis of active pharmaceutical ingredients (APIs) for preclinical and clinical development of new pharmaceutical products.
Responsibilities will include, but are not limited to, the following:
• Directs engineering process development activities associated with the Celgene small molecule drug candidate portfolio.
• Leads a high performing technical team of development engineers who are cross-functionally integrated with colleagues across the Drug Substance Development department, with partner groups in the Pharmaceutical Development area, and with other internal and external partners.
• Provides oversight and direction for teams responsible for: creating and executing API process development and GLP/GMP supply plans; developing and documenting the knowledge base needed for regulatory filings; and managing projects through early/mid stage development and process-readiness for late-stage clinical development, filing, and commercial launch.
• Provides oversight and technical support and direction to activities for GLP and GMP API manufacturing at Celgene and CMO facilities to deliver material for clinical development programs and to generate process knowledge for further scale-up and development.
• Provides input to the development of program strategy, budgets, timelines, and process development plans. Ensures that technical and business requirements are managed and met.
• Creates, promotes, and improves engineering technical capabilities and related workflows for the Drug Substance Development department and Pharmaceutical Development area, and with associated partners.
• Develops and implements an engineering technology strategy within Drug Substance Development and partner groups, including:
o Identifies and develops tools and methods for acquiring engineering scale-up data;
o Develops and applies tools for process modeling and simulation;
o Establishes process technologies with line-of-sight to application in pilot- and commercial-scale equipment trains.
• Acts as CMC reviewer and subject matter expert for all drug substance regulatory section submissions. Acts as a subject matter expert during Health Authority interactions.
• Participates in due diligence assessments and may serve as the department’s direct interface with alliance partners, with responsibility for risk assessment, financial and strategic planning, and project guidance responsibilities to protect the Company’s interests and resource investments.
• Builds and maintains strong working relationships with relevant internal and external partner groups (including Research and Early Development, Pharmaceutical Development, Project Leadership, Business Development, Technical Operations, Regulatory CMC, and Quality, as well as alliance partners and CRO/CMO partners), ensuring that activities are managed collaboratively, efficiently, and effectively.
• 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 2 to 5 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/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.
• 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.
• Minimum BS degree in Chemical Engineering or related engineering/scientific discipline required. Advanced degree preferred.
• 10+ years of relevant experience in drug substance process development, scale-up, and technology transfer in the pharmaceutical industry, with a demonstrated track record of scientific and leadership responsibilities.
• Excellent communication, interpersonal and management skills to collaborate on and direct the work of others on assigned projects (including both internal teams and external collaborators).
Req ID: 14000996
Primary Location: United States-New Jersey-Berkeley Heights
Organization: Celgene Corporation
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
Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.