Entry Level or Intern Scientist / Regulatory Associate (CMC)
Oncotelic Therapeutics, Inc. is a pharmaceutical company who specializes in TGF-beta 2 antisense for the treatment of metastatic pancreatic cancer and high-grade glioma. We are seeking an entry-level or intern Scientist / Regulatory Associate that will support the Chemistry, Manufacturing, and Controls (CMC) department of the company. This individual is someone that is an independent thinker/worker and can thrive in a fast-paced, innovative environment to help develop and drive the success of the CMC department. Only local candidates near the San Diego, Orange or Los Angeles County will be considered.
Key Responsibilities:
- Assist in CMC-related submissions and manage regulatory writing and timely delivery of high-quality technical documents.
- Interacts with colleages in other departments, and RA functions to deliver high-quality dossiers, documents, and materials in accordance with corporate and team goals.
- Regulatory support on technical and quality activities, such as manufacturing process development, specifications, in-process controls, stability protocols, and product and compliance quality initiatives.
- Maintain knowledge and expertise of the regulatory documentation system(s) to ensure efficiency, traceability, and compliance of regulatory CMC documents.
Essential Qualifications:
- Degree in science or engineering field required.
- Proficient skills in Microsoft Office suite, especially Word, Excel, and Powerpoint.
- Independent thinker who is able to work as a member of a team.
- Strong organizational skills with attention to details as well as excellent time management skills.
- Motivation with the initiative to learn new concepts quickly.
Preferred Qualifications:
- Experience in bio or pharmaceutical industry.
- Experience in CMC, including preparation of submissions to Agencies, i.e. FDA, EMEA, etc.
If interested, please send your application to chsiao@oncotelic.com.