Prerequisites
- ≥ 7 years of experience within the pharmaceutical/biotechnology industry or CDMO industry is required.
- ≥ 3 years of experience in small molecule cGMP processing, analysis and/or release testing is required.
- ≥ 3 years of experience in process chemistry is preferred, but not required.
- BA/BS degree in chemistry, chemical engineering or pharmaceutical sciences is required.
Responsibilities
- Support J-STAR’s Quality System for the manufacture, testing, and release of APIs and intermediates in accord with cGMP regulations and related FDA/ICH guidelines.
- Maintain J-STAR’s Quality System in a manner consistent with FDA/ICH requirements for cGMP manufacture and testing for APIs in early clinical phases.
- Promote compliance with cGMP regulations. Present and coordinate GMP training sessions.
- Support management and maintenance of the SOP and Document Control system.
- Author, review, update, and approve quality documents, specifications, and procedures as needed.
- Conduct timely review and approval of batch process and analytical records. Release APIs and intermediates manufactured subject to GMP compliance.
- Provide guidance to GMP personnel and ensure that deviation and OOS investigations are adequate and completed in a timely manner.
- Ensure that change control is enforced for critical systems, procedures, and specifications.
- Audit and approve suppliers of materials and services critical to GMP activities.
- Participate in internal audits to assess GMP compliance and identify potential gaps or training needs. Develop and implement corrective actions to address observations.
- Act as secondary J-STAR contact for client audits and regulatory inspections. Track completion of post-audit action items.
- Work with clients to develop material release tests and specifications for materials supplied by JSTAR.
- Help ensure that client project needs, requirements, and timelines are communicated to, and coordinated between, cGMP Operations and Quality Control.
- Respond to client inquiries and provide information and updates as needed and appropriate to support regulatory filings.
Qualifications
- Proven track record of setting and meeting aggressive targets and timely execution of objectives.
- Excellent written, verbal and communication skills.
- Ability to prioritize and manage numerous projects simultaneously.
- Ability to interact in an effective and appropriate manner with diverse population sets.
- Ability to communicate candidly, clearly and timely.
- Experience in working on, positively contributing to, and leading teams.
- Proficient in Microsoft®Office™and other job-related software and applications.
Reporting Relationship
- Reports to the Director of Quality Assurance
Job Location: New Jersey