Location
Hightstown, NJ | United States
Job description
Title: Principal Investigator
Location: East Windsor, NJ
Schedule: M-F Full Time
Type: Direct Hire
Responsibilities:
The Principal Investigator is responsible for the management and integrity of the design, conduct, and reporting of QMS elements and for managing, monitoring, and ensuring the integrity of any collaborative relationships.
- Authoring and resolution of deviations, change controls, CAPAs, or documents to meet production and product release requirements.
- Identification and facilitation of interdepartmental process improvements.
- Utilize root cause analysis techniques during deviation investigational process.
- Work cross-functionally, to develop and implement continuous process improvements.
- Support production needs and continuous improvement including change control, deviation writing/review, CAPA implementation, and operational optimization.
- Write, review, revise, and prepare manufacturing documents (BPR, SOP, WI) in accordance with cGMP and regulatory guidelines.
- Communicate across multiple groups and levels to obtain consensus to facilitate deviation closure.
- Manage multiple priorities either independently or as part of a team to meet key deadlines and communicate issues and progress across all levels of the organization.
- Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
- Sterile product development includes formulation, stability, process development/characterization and technical transfer.
- Bioanalytical and biophysical testing, and data analysis
- Demonstration of data integrity principles
- Mentoring/developing staff in proper scientific study design, execution, and report writing.
MUST HAVES:
- High School Diploma and 3+ years’ cGMP experience.
- Associate degree and 2+ years’ cGMP experience
- Bachelor’s degree and 1+ years’ cGMP experience
- Must have knowledge of continuous improvement techniques and critical thinking skills. (CAPA, Change Control, Deviations Exp.)
- Previous experience working within a production department of a pharmaceutical company preferred.
- Expertise in developing lyophilized and sterile drug product manufacturing processes.
- Experience in Sterile drug product process development, Microbiology, Facility Engineering, Manufacturing, Supply Chain, Validation, and EHS
- Experience in the application of state-of-the-art laboratory equipment and software.
- Experience evaluating, developing, and qualifying manufacturing equipment.
- Ability to follow written instructions precisely and perform basic math calculations.
- Understanding/knowledge of cGMP, safety criteria or the ability to learn
- He/she should have basic computer knowledge.
- He/ she should know how to operate a reach truck
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