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 Scientist II will work within the late stage Biologics Formulation and Drug Product Development organization to lead formulation, drug product process development, and primary packaging development activities for therapeutic protein products at various stages of development.
The successful candidate will design and 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 up to commercialization.
• Will contribute to setting-up the biologics formulation and drug product development labs to support phase-appropriate development activities. Will implement state of the art technologies, including the use of innovative and high throughput approaches to design robust formulations and manufacturing processes suitable for therapeutic protein products.
• Will participate in and/or lead drug product development teams and be responsible for the planning and execution of product development plans including all aspects of formulation and drug product process development, technology transfer, scale-up, and validation activities, based on project goals and timelines.
• Will support CMO investigations, provide technical support to manufacturing, and interact with internal and external customers and stakeholders to support assigned projects. Will interface with cross-functional areas and CMC project teams to drive project milestones.
• Will generate high quality data based on sound scientific principles and summarize the results in technical reports, scientific papers, presentations, and regulatory documents.
• Will maintain currency with applicable global regulations and industry standards for formulation and drug product development for recombinant therapeutic proteins.
• Will maintain and enforce safe laboratory practices and environment.
Will interact effectively with members of the Biologics Development department, and with other Celgene stakeholders (Quality, Regulatory CMC, Global Manufacturing, Project Leadership, Commercial, and Clinical organizations).BIO-US
Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with a minimum of 3-5 yrs of relevant industrial experience in formulation and drug product development of therapeutic protein products. MS with more than 10 years of relevant industrial experience will also be considered.
Skills and Knowledge Required:
• Strong scientific background and hands-on experience in protein formulation, drug product process development for liquid and lyophilized products, and biophysical characterization of proteins.
• Demonstrated experience to work independently and conduct experiments to evaluate the optimal formulations for biological products and establish robust process conditions for product manufacturing.
• Technical expertise in several aspects of drug product formulation and manufacturing unit operations, including bulk storage, freeze/thawing, compounding, mixing, sterile filtration, filling, lyophilization, and primary packaging.
• A thorough understanding of the relationships between formulation, manufacturing process, and device design for the performance, quality, and stability of biological drug products.
• Experience in multiple approaches for experimental design and statistical data analysis including Design of Experiments (DoE) and multivariate analysis modeling.
• Working knowledge of current US, EU , and global Regulations, ICH guidance and relevant standards and quality system requirements for biological product manufacturing.
• 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.
• Strong project and time management skills are essential.
• Demonstrated ability for critical thinking, problem solving and innovation.
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.