Job Description :
Note:
Red Flags: No GMP experience, no relevant Stability Program or industry experience, no experience with computer-based LIMS systems.
Interview Process: Interview process will consists of phone screens with manager and select staff (senior staff in the team
Description:
Provide technical support to the Product Quality (PQ) organization by working within a team environment. Responsible for the creation, review, verification, and archival of product quality technical data supporting Client’s clinical and commercial programs.
Own and manage the historical product quality data sets and serve as a primary author or partner closely with key stakeholders to draft PQ/stability owned regulatory filing sections. This will include ownership, authoring and review of documents, and execution of transactions in relevant GMP systems (change control, LIMS, etc and may include additional business process support including support for site audits, as needed. Will also be responsible for coordination and problem resolution within multiple departments (manufacturing, process development, Quality control, etc.
Requirements:
GMP experience 3-5 years.
Quality 2+years of experience.
Expertise in computer-based LIMS system.
Familiar with quality, compliance and regulatory requirements, and knowledge of analytical techniques used for biologics product quality control.
Familiarity with product stability requirements for biologic and small molecules.
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals.
Preferred bachelor in Life Sciences and Client experience.
Preferred Qualifications:
B.S. in biochemistry, biology, or a related protein/biotechnology sciences field or an equivalent level of Biopharmaceutical experience with responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
Understanding of biopharmaceutical bulk and drug product development and manufacturing.
Strong project management skills.
Previous experience working on a cross-functional team in a matrix environment.
Excellent written and verbal communication skills, including facilitation and presentation skills.