Celgene Senior Associate Scientist Biologics Formulation in Summit, New Jersey
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.
Sr Associate Scientist, Biologics Formulation & Drug Product DevSummit, NJ
The Senior Associate Scientist is a hands-on laboratory position within the Biologics Drug Product Development function, responsible for conducting experiments to develop robust and scalable formulations and manufacturing processes for therapeutic proteins.
Carefully plan and conduct experiments to develop formulations, drug product manufacturing processes, and primary container configurations (including combination products) to be transferred to CMOs for biologic products at different stages of development.
Contribute to setting-up the drug product development labs and will be responsible for operation and basic maintenance of the laboratory and analytical equipment.
Perform basic analytical testing including UV-Vis, HPLC, and other assays, and support stability studies leading to formulation decisions and stability predictions.
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.
Degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry or equivalent
Experience: M.S. with a minimum of 4 years or B.S. with a minimum of 6 years of relevant industrial experience in biologics formulation and drug product development.
Experience in conducting experiments to evaluate the optimal formulations for biological products and establish robust process conditions for product manufacturing.
Prior experience in some or all drug product development and/or manufacturing competencies, including formulation, compounding, sterile processing, filling, and lyophilization.
Experience in basic analytical methods to measure concentration, aggregation, charge heterogeneity, etc to support stability studies
Experience in DOE studies and statistical experimental design is a plus.
Familiarity with GMP and compliance is a plus.
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.
Meticulous with 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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.