Quality Assurance, CMC
Abide Therapeutics is seeking a highly motivated, Quality Assurance team member to contribute to the identification and development of novel small molecule drugs targeting the serine hydrolase enzyme family. Abide’s mission is to develop innovative medicines that target serine hydrolases, one of the largest enzyme classes in nature with validated, but mostly untapped, therapeutic potential. Abide is a privately held biotechnology company. This position will be based in San Diego, California.
The successful candidate will review and approve all quality documentation associated with drug substance and drug product manufacturing for all phases of development, including but not limited to, batch records, in-process controls, change controls, deviations, out of specifications, labeling, release and stability data. In this role, a successful candidate will interact with key stakeholders in CMC and clinical operations to ensure that clinical drug products are manufactured in accordance with established procedures, cGMPs and the appropriate regulations. The candidate will interface directly with contract manufacturing organizations and other partners to manage and perform quality audits and manage quality-related issues. The successful candidate will ensure timely disposition of drug products intended for human clinical use while ensuring compliance within a regulatory filing. The candidate will be responsible for developing and managing the Abide Quality Management Systems, including authoring SOPs, overseeing and developing data governance and lifecycle, developing document control, managing quality agreements, ensuring Data Integrity principles are being followed both internally and with external contract organizations, and building a robust training program.
Experience and education requirements:
- BS/MS plus 10 years QA experience, or equivalent, in the pharmaceutical industry
- Chemistry degree preferred
- In depth knowledge of quality management systems and worldwide cGMP standards for chemistry, manufacturing, and controls (CMC)
- In depth knowledge for the release, labeling, control and distribution of clinical supplies
- Experience developing, implementing and performing Quality Risk Management to different aspects of pharmaceutical quality
- Experience in setting up and developing Pharmaceutical Quality Management Systems (QMS) from the ground floor
- Establishing Product Quality Reviews
- Experience in establishing Data Integrity, Data Governance and Data Lifecycle Policies and Procedures
- Experience with small molecule manufacturing, including oversight, review and approval of batch records, review and approval of release testing, and stability program establishment and review and approval of test results
- Experience conducting quality audits of contract manufacturing and analytical organizations
- Substantial knowledge of the industry best practices and trends
- Excellent oral and written communication skills
- Outstanding problem solving skills, troubleshooting skills and organization skills
- Both effective team player and strong individual contributor, flexible, and able to handle multiple tasks and deliver high quality results under tight timelines
- Ability to travel to contract organizations for onsite meetings and audits
For additional information about Abide Therapeutics, Inc. please visit our website at www.abidetx.com. In addition to a competitive compensation package with stock options, Abide also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, life, disability and a 401(k) Plan. For consideration, please submit your resume and cover letter referencing job QA2018.11.21. Abide Therapeutics, Inc is an EEO employer.