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.
Principal Scientist Combination Products, Biologics Formulation Dev
The Principal Scientist Combination Products is responsible for establishing key in-house capabilities to support development of formulations for biologics combination products in prefilled syringes, cartridges, dual chamber syringes, and other primary packages based on project requirements. In parallel, the incumbent will support combination product development at CROs as required.
Subject Matter Expert (SME) in combination product development with experience in developing prefilled syringes, large volume injector, dual chamber syringes, etc.
Establish internal capabilities to support formulation development, functionality testing and other requirements for combination product development. Adopt industry best practices.
Collaborate with Device Development to establish suitable laboratory capabilities including instrumentation required for successfully developing biologics combination products for Global registration.
Support combination product development at CROs for existing programs until in-house capabilities are sufficiently established.
Establish key supplier relationships with premier suppliers of primary packaging components such as PFS, elastomeric components, glass suppliers, needle suppliers, patient safety components and secondary packaging suppliers.
Collaborate with Quality and Device functions to support requirements related to Quality, design history, human factors studies, etc.
Train and mentor junior scientists and colleagues.
Manage CROs and troubleshoot technical investigations, provide technical expertise to manufacturing, and interact with internal/external customers and stakeholders.
As a drug product representative, lead drug product development teams and interface with cross-functional areas and CMC project teams to drive project milestones.
Use innovative and high throughput approaches internally as well as externally to design robust formulations and manufacturing processes suitable for therapeutic protein products
Demonstrate independent, scientifically-directed and innovative thinking. Interpret contingency plans from analysis of risks, and present alternatives consistent with industry practices.
Maintain current knowledge in applicable global regulations and industry standards for development of protein combination products. Write and review regulatory filings.
Interact with members of the Biologics Development & Manufacturing department, and with other Celgene stakeholders (Quality, Regulatory CMC, Project Leadership, Business Development, Commercial, and Clinical organizations).
Degree in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with 12+ years of industrial experience in Development and registration of biologics combination products
Experience: PhD. with 12+ years of relevant experience
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.
Experience in working with CMOs/CROs.
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.
Strong scientific background, experience and demonstrated ability to develop biologics for clinical and commercial use, and technology transfer.
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 combination 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 and writing/preseentation skills
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.