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 supporting commercial product definition, leading process development, scale-up, registrational stability batch mfg., technology transfer, supporting validation, and providing in-line technical support.
Responsibilities will include, but are not limited to, the following:
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 team lead and represent the team on multidisciplinary CMC teams.
Leverage understanding of formulation design and development to support commercial product definition.
Develop process development strategies to define manufacturing processes for commercialization.
Responsible for the design and execution of complex experiments to characterize drug product manufacturing processes utilizing various technologies.
Ensure fundamental engineering principles are applied to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches.
Lead the identification, development, and deployment of new instrumentation, technologies, and methodologies to support efficient and effective drug product process development.
Manage drug product process development/technology transfer to Contract Research/ Manufacturing Organizations.
Provide technical support for clinical manufacturing.
Prepare technical reports, publications and oral presentations and contribute to the preparation of CMC regulatory documents.
Serve as a resource of scientific and technical expertise.
Coach and develop scientists/engineers under a project specific matrix team.
Assume departmental responsibilities for assigned projects and equipment.
Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
Ph.D. with minimum 8 years’ experience in engineering or related field; M.S. with minimum of 10 years’ experience in engineering or related field; or, B.S. with minimum of 12 years in engineering or related field.
Strong background in pharmaceutical development as it relates to formulation development and process development/optimization.
Demonstrated expertise in leading scale-up and technology transfer, moving from laboratory to pilot plant and production scale.
Experience across various solid oral dosage conventional and enabling manufacturing technologies.
Demonstrated capability orchestrating development and execution of an experimental program 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.
Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.
Knowledge of cGMPs during pharmaceutical development and clinical/commercial manufacturing.
Demonstrated proficiency in balancing resource requirements within projects and among multiple assigned projects.
Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work independently or in leading a team under deadline. Strong verbal and written communication skills are essential.
Experience with broad CMC 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.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.
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