Other Locations:US- NJ- Summit West
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 Principal 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 a subject matter expert within drug product development with responsibilities such as formulation development, lyophilization and process development, primary packaging development, technology transfer to CMOs, scale-up, and related activities for early and late stage biologics projects
- Will facilitate growth of less experienced colleagues. May include supervision of other development staff, either internally or at CROs.
- Will manage CROs and CMOs and will troubleshoot technical investigations, provide technical expertise 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 lead the use of innovative and high throughput approaches internally as well as externally to design robust formulations and manufacturing processes suitable for therapeutic protein products
- Will have excellent writing skills
- Will demonstrate independent, scientifically-directed and innovative thinking. Will interpret contingency plans from analysis of risks, and will present alternatives consistent with industry and company protocols.
- 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).
- Will develop strategies and will be accountable for success of the same
Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with more than 10 years’ industrial experience in formulation, drug product process development, and registration of therapeutic protein products. MSc with more than 15 years or BSc with more than 20 years of relevant industrial experience will also be considered.
- The ideal candidate has 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 highly preferred.
- Has experience in working with CMOs/CROs.
- Has in-depth understanding of all aspects pertaining 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.