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 Associate Director level position in Biologics Development will oversee process development, technology transfer and manufacturing activities at CMOs and collaborations with external partners for monoclonal antibodies and other therapeutic protein products. The successful candidate will also support the implementation of internal process development capabilities. Reporting to the Director, Biologics Development, successful execution of this role requires a strong scientific and engineering approach, established expertise in upstream and/or downstream process development for therapeutic proteins, process characterization and process validation experience, technology-transfer experience, the ability to establish mutual respect, trust, and close collaborations with internal and external partners, excellent written and oral communication skills, and the ability to interact effectively at all levels in both, internal and external organizations.
Responsibilities will include, but are not limited to, the following:
1. Oversee all the scientific and engineering aspects of process development, technology transfer, and CMO-based manufacturing of large molecules including but not limited to monoclonal antibodies, fusion proteins, bi-specifics, and antibody-drug conjugates in mid to late stage development.
2. Oversee and manage process characterization and process validation studies, as well as technology transfer.
3. Project and logistics management of outsourced development and manufacturing activities at CMOs.
4. Manage external collaborations, ensuring close partnership through open and transparent communications, scientific and strategic understanding, and attention to partner priorities, to maximize integration and synergy between Celgene and collaboration partner.
5. Use sound scientific and engineering criteria to design and develop manufacturing processes, identify and execute process improvement/ optimization strategies, and ensure successful scale-up and technology transfer of biologic products.
6. Identify appropriate CMOs, complete contract(s), and manage technology transfer to support scale-up and GMP manufacturing.
7. Exercise independent judgment and apply technical, regulatory, and project experience to develop and implement a CMC process development strategy to support successful regulatory submissions and approvals
8. Ensure suitable quality, optimized economics, and adequate supply chain security to support product development lifecycle up to commercial registration..
9. Lead or participate in Project and CMC development teams, as required.
10. Establish effective working relationships within Biologics Development and Pharmaceutical Development, and with other Celgene functions, including Research, Technical Operations, Regulatory CMC, Quality Assurance and Legal departments.
11. Understand and keep-up with the Intellectual Property (IP) landscape around process technologies and biologic products. Develop and implement IP strategies to ensure Freedom To Operate.
Ph.D. in relevant discipline and 8-10 years industrial bioprocess development, scale-up , technology transfer and clinical and/or commercial manufacturing. Masters degree may be considered with more than 12 years of relevant industrial experience.
• Ph.D. in biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline with 8-10 years industrial bioprocess development and manufacturing experience, including mammalian cell culture and associated downstream unit operations.
• Masters degree in one of these disciplines may be considered with more than 12 years relevant industrial experience.
• Proven experience in late stage biologics development, process characterization and process validations.
• Downstream processing experience is preferred.
• Experience in management of out-sourced manufacturing/development activities.
• Proven tech transfer and scale-up experience, from development lab to cGMP manufacturing.
• Demonstrated ability to function in a collaborative/team oriented CMC environment.
• Ability to influence others without direct authority.
• Ability to communicate and connect with all levels of the organization
• Strong project leadership and resource management skills.
Good verbal and written communication skills.
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.
Req ID: 16000145
Primary Location: United States-New Jersey-Summit
Organization: Celgene Corporation
Employee Status: Manager
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 10 % of the Time
Job Posting: 2016-01-18 00:00:00.0
Biochemistry, Biologist, Biology, Biotech, Business Process, Cell Biology, Chemical Engineer, Chemical Research, Engineer, Engineering, Healthcare, Intellectual Property, Law, Legal, Logistics, Management, Manager, Medical, Medical Lab, Operations, Pharmaceutical, Product Development, QA, Quality, Quality Assurance, Research, Science, Scientist, Supply, Supply Chain, Technology