Location: San Diego, California, United States
Job Category: Technical Development
Work Location: 3033 Science Park Road 92121
Employee Status: Full-time
Job Type: Regular
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 some 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.
- Assist in the management of business relationships with development and commercial contract manufacturing service providers and business partners
- Support Quality Assurance on quality system and compliance activities
- Assist in the review and approval of 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 help facilitate their implementation
Knowledge, Skills, Abilities and Qualification Requirements:
- Advanced degree in Organic Chemistry or related field
- 1-5 years’ experience as a synthetic organic chemist
- 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
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.