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 Senior Scientist will work within the Biologics Development & Manufacturing organization as a lead scientist for Drug Product development (formulation and process) activities for therapeutic protein products in various stages of development.
•The successful candidate will be responsible for technical planning and execution of formulation development, drug product process development, primary packaging development, technology transfer to CMOs, scale-up, characterization and validation activities for protein therapeutics programs.
•May include supervision of other development staff, either internally or at CROs.
•Will work closely with CROs and CMOs to troubleshoot technical investigations and challenges, provide technical support to manufacturing, and interact with internal/external customers and stakeholders.
•As a drug product representative, will lead drug product development teams and will interface with cross-functional areas and CMC project teams to drive project milestones.
•Will support the use of innovative and high throughput approaches to design robust formulations and manufacturing processes suitable for therapeutic protein products in various stages of development.
•Will generate high quality data based on sound scientific principles and summarize results in technical reports, scientific papers, presentations and regulatory documents.
•Will be knowledgeable in applicable global regulations and industry standards for formulation and drug product process development for recombinant therapeutic proteins. Will write and review regulatory filings.
•Will interact effectively with members of the Biologics Development & Manufacturing department, and with other Celgene stakeholders (Quality, Regulatory CMC, Project Leadership, Business Development, Commercial, and Clinical organizations).
Pre-requisites Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with a 5 - 10 years’ industrial experience in formulation, drug product process development, and registration of therapeutic protein products. MSc with more than 12 years of relevant industrial experience will also be considered.
•The ideal candidate will have demonstrated track record of successful formulation and drug product development, supporting clinical/commercial programs for recombinant protein products, including filing of INDs/IMPDs for products in various stages of development. Prior experience supporting BLA submissions preferred.
•Has experience in working with contract manufacturing and contract research organizations.
•Has deep technical understanding of all aspects pertaining to formulation and drug product development of liquid and lyophilized biological products, including experience with multiple primary packaging configurations and combination products.
•This role requires a strong scientific background, experience and demonstrated ability to develop biologics for clinical and commercial use, and tech transfer of early to late stage biologics.
•Demonstrated ability for critical thinking, problem solving and innovation.
•Must have a thorough understanding of GMP manufacturing and GMP compliance.
•Working knowledge of current US, EU, and global Regulations, ICH guidance and relevant standards and quality system requirements for biological product manufacturing.
•Strong communication skills, good interpersonal skills, ability to multi-task, publication track record and a strong desire to learn, contribute and collaborate.
•Proven ability to work effectively within the department and with cross-functional stakeholders.
•Proven track record of strong project leadership capabilities.
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.