Celgene Process Development Scientist, API Development & Manufacturing in San Diego, California
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 activities associated with the development of small molecule active pharmaceutical ingredient (API) within Celgene and in contract development and manufacturing organization (CDMO). The individual would be expected to investigate and execute syntheses of complex molecule, develop scalable chemical manufacturing processes, and assist with technology transfers to CDMOs. He/ She will also serve as a resource of scientific and technical expertise and assume departmental responsibilities for assigned projects and equipment.
Responsibilities and Duties:
Develop, investigate, and execute syntheses of complex molecule
Develop scalable chemical manufacturing processes.
Synthesize compounds for use as analytical reference standards.
Assist with technology transfers to CDMOs.
Prepare technical reports, publications, and oral presentations.
Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
Remain current with required GMP training and qualifications.
Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements.
Assist in the preparation of CMC regulatory documents.
Manage supply and business relationships with development and commercial contract manufacturing service providers and business partners
Manage organizational resources to ensure that equipment qualification, process validation and cleaning validation programs and procedures are established and followed at approved CDMOs
Oversee execution of process optimization studies using design of experiment (DOE) and quality by design principles
Support Quality Assurance on quality system and compliance activities
Review and approve executed and master batch records, manufacturing deviations, and OOS laboratory test results as necessary to support resolution of production issues
Identify cost reduction opportunities and facilitate their implementation
Knowledge, Skills, Abilities and Qualification Requirements:
Advanced degree in Organic Chemistry or related field
Excellent laboratory skills and knowledge of organic synthesis.
Expertise in the use and interpretation of NMR, MS, IR, HPLC, and GC.
Proven track record in developing innovative routes and processes for the synthesis of complex molecules.
Ability and will to learn and implement relevant principles of chemical engineering, material science, analytical chemistry, and regulatory guidelines.
Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
Ability to work independently or in a team under deadline.
Verbal and written communication skills are essential.
Knowledge of GMPs, quality systems and industry standards a plus
Excellent oral and written communication skills with strong interpersonal skills
Competency in Word, Excel and PowerPoint
Pilot plant and/or commercial manufacturing experience a plus
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.