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 process development, process characterization, scale-up, and technology transfer activities of small molecule drug products (DPs) for clinical development of new pharmaceutical products.
Responsibilities will include, but are not limited to, the following:
Managing a team of process engineers/scientists responsible for the development and commercialization of parenteral and lyophilized drug products.
Key member of a dynamic scientifically driven team, dedicated to the development and optimization of robust manufacturing processes for drug products.
Serve as Drug Product Development representative on multidisciplinary CMC teams.
Contribute and shape the strategic vision of the Drug Product Development Organization to develop product and process understanding in order to support commercialization and continuous supply.
Serve as a technical resource during the design and execution of complex experiments to characterize drug product manufacturing processes utilizing various technologies.
Champion the application of fundamental engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches.
Champion the identification, development, and deployment of new instrumentation, technologies, and methodologies to support efficient and effective drug product process development.
Provide strategic and technical leadership for drug product process development/technology transfers to Contract Research/ Manufacturing Organizations.
Review CMC regulatory documents.
Serve as a resource of scientific and technical expertise.
Coach and develop scientists/engineers under a project specific matrix team.
Assume responsibilities for assigned projects and departmental 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 to 12 years of experience in engineering or related field; or
M.S. with 12 to 14 years of experience in engineering or related field; or.
B.S. with 14 to 16 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.
Effectively orchestrate development and execution of experimental programs to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines. Demonstrated record of implementing novel and creative solutions to overcome process development obstacles.
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 assigned 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).
Ability to supervise, coach, and mentor junior-level engineers.
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.
About Celgene Corporation
Celgene CorporationDriven by PASSION FOR THE PATIENT.
-Preeminent Global Biopharmaceutical Company- ~8,000 Employees Worldwide- Operations in >60 countries and sales in >70 countries.
-Focused on Discovery, Development and Commercialization of Innovative Therapies for Unmet Medical Needs in Cancer and Immune-Inflammatory Diseases.
- 8 marketed products (hematology, oncology and immunology)- Focused on R&D; >30 Phase III programs underway and 300+ clinical trials
- Diverse technology platforms and commitment to sustaining innovation