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.
This position is responsible for ensuring supply of clinical trial material and supporting process development, process characterization, scale-up, and technology transfer activities of small molecule drug products (DPs) in development.
Responsibilities will include, but are not limited to, the following:
- Managing a team of process engineers responsible for supply of clinical drug product for development/commercial portfolio.
- Contribute and shape the strategic vision of the Drug Product Development Organization to develop robust manufacturing processes for clinical manufacturing and subsequent commercialization.
- Support management of clinical manufacturing Contract Research / Manufacturing Organization (CRO / CMO) network (expanding network and/or building capability within the current network).
- Provide strategic and technical leadership for drug product process technology transfers to CROs / CMOs.
- Provide guidance during manufacturing deviation investigations at Celgene’s clinical manufacturing CMO vendor network
- Champion the application of fundamental engineering principles to characterize and solve process challenges across multiple unit operations.
- Serve as a technical resource during the design and execution of complex experiments to characterize drug product manufacturing processes utilizing various technologies.
- Review CMC regulatory documents.
- Assume responsibilities for assigned departmental capability build initiatives.
- Ensure safety, regulatory, and compliance standards are followed as they relate to the development of pharmaceuticals.
- Review technical reports, publications, and oral presentations.
Ph.D. with 10+ years of experience in engineering or related field; or
M.S. with 12+ years of experience in engineering or related field; or.
B.S. with 14+ years of experience in engineering or related field.
- Recognized as a leader in pharmaceutical development across Celgene and the external community as it relates to formulation development and process development/optimization.
- Considered as a subject matter expert in the development and commercialization of various solid oral dosage conventional and enabling manufacturing technologies.
- Recognized within Celgene and the external community as an expert in quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.
- Strong knowledge of cGMPs during pharmaceutical development and commercial manufacturing.
- Demonstrated proficiency in balancing resource requirements within projects and among multiple projects/departmental initiatives.
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability leading a team under deadline. Strong verbal and written communication skills are essential.
- Effectively anticipate CMC regulatory issues encountered in drug development, thorough understanding of applicable regulations, and experience with authoring relevant sections of regulatory filings (INDs/NDAs).
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.