Responsibilities will include, but are not limited to, the following:
1. Leading downstream protein purification development of large molecule/recombinant proteins from traditional cell culture, microbial fermentation, or new and unconventional bioprocesses, including second generation therapeutic antibodies, antibody-drug conjugates, bi-specific antibodies and fusion proteins.
2. Overseeing all aspects of downstream process development and bioprocess unit operations, including conjugation and other reactions, centrifugation, depth filtration, chromatography, TFF, viral inactivation and viral filtration.
3. Development of robust and scalable protein production and purification processes for Celgene biologics candidates to final purified protein at small and pilot scales, and scale up for clinical and commercial production
4. Identifying, contracting and transferring technology to CMOs appropriate for scale-up and GMP implementation. Identification of appropriate equipment for manufacturing of candidate proteins. Supporting manufacturing processes
5. Assuring production of clinical material to meet project timelines and supply requirements
6. Participating in Project and CMC teams, in leadership and team member roles, as required
7. Partnering extensively within Biologics and Pharmaceutical Development, and with other Celgene functions, including Research, Regulatory CMC, QA, Tech Ops and Legal
8. Understanding the IP landscape around subject technologies and products, and developing and implementing IP strategies to ensure FTO and to create and strengthen the patent estate in the field
9. Establishing a new in-house laboratory and downstream group to enable Celgene development of novel biologics
10. Recruiting and hiring additional process development professionals as portfolio demands dictate

Qualifications
Prerequisite:
Ph.D. in biochemical/chemical engineering, biological sciences or relevant discipline and over 10 years of industrial protein purification/ DSP development experience in production of recombinant therapeutic proteins

Skills/Knowledge Required:
 Ph.D. in biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline
 Over 10 years industrial experience of protein purification from traditional cell culture processes, microbial fermentation processes and novel production technologies
 Hands on experience of protein purification operations and downstream process equipment at development and pilot scales
 Proven technology transfer and scale-up experience, from development lab to pilot plant and into cGMP facilities
 Strong scientific and engineering approach to problem solving and process development and optimization. Ability to introduce new technologies to improve and accelerate downstream process development and improve process efficiency
 Knowledge of small scale manufacturing model qualification, process optimization with risk analysis, FMEA methodology, and process characterization. Use of statistical experimental design and data analysis.
 Knowledge and/or experience with upstream process development is desired
 Strong project leadership and resource management skills; demonstrated ability to simultaneously manage multiple projects
 Demonstrated ability to function in a collaborative/team oriented R&D environment.
 Ability to communicate and connect with all levels of the organization
 Good verbal and written communication skills.