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 novel therapies in Hematology, Oncology, Inflammation and Immunology that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge.
We are building in-house biologics development capabilities over the next few years to support our growing portfolio of exciting biologic candidates. This is a unique opportunity to join the biologics development team and help us build a first class, science and technology based organization. We are looking for talented and experienced scientists and engineers that are excited by the opportunities provided by a fast growing organization, are interested in advancing our science and to contribute to our dynamic culture.
Summary: The Senior Associate Scientist will work within the late stage Biologics Formulation and Drug Product Development organization and will conduct experiments to develop robust and scalable manufacturing processes for biologic products, including monoclonal antibodies, fusion proteins and other therapeutic proteins.
• The successful candidate will conduct experiments to develop formulations, manufacturing processes, and primary container configurations (including combination products) to be transferred to CMOs for biologic products at different stages of development.
• Will contribute to setting-up the drug product development labs and will be responsible for operations and basic maintenance of the laboratory equipment.
• Will participate in drug product development teams and contribute to the planning and execution of product development studies including all aspects of formulation and drug product process development, technology transfer, scale-up, and validation activities, based on project goals and timelines.
• Will design, execute, and interpret development studies based on defined project objectives by working closely with the drug product project lead and development team.
• Will generate high quality data based on sound scientific principles and summarize the results in technical reports, scientific papers, presentations, and regulatory documents.
• Will interact effectively with members of the Biologics Development department, and cross-functional internal and external partners.
MSc in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with a minimum of 4 yrs of relevant industrial experience in formulation and drug product development of therapeutic protein products. BSc with a minimum of 6 years of relevant industrial experience will also be considered.
Skills / Knowledge Required:
• Scientific background and hands-on experience in protein formulation, biologic drug product process development for liquid and lyophilized products, and biophysical characterization of proteins.
• Demonstrated experience in conducting experiments to evaluate the optimal formulations for biological products and establish robust process conditions for product manufacturing.
• Technical expertise in at least one aspect of drug product development and/or manufacturing processes, including formulation, compounding, sterile processing, filling, lyophilization, and primary packaging.
• Basic understanding of the relationships between formulation, manufacturing process, and device design for the performance, quality, and stability of biological drug products.
• Experience in statistical experimental design and data analysis including Design of Experiments (DoE).
• Understanding and experience with GMP manufacturing and compliance preferred.
• Proven ability to work effectively in team structures and collaborate with cross-functional internal/external partners.
• Demonstrated ability for critical thinking, problem solving and creativity in the laboratory.
• Strong organizational and planning skills.
• Strong written and verbal communication skills, good interpersonal skills, ability to multi-task, publication track record and a strong desire to learn, contribute and collaborate.
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.