What are the responsibilities and job description for the Person In Plant position at Pharmatech Associates?
We are looking for a Person In Plant to join our consulting team and provide market leadership to support a client that is in late stage development. The plant is located in College Station, TX.
- Provide Person-in-Plant (PIP) coverage for all CDMO related activities associated with process development, quality, regulatory and manufacturing
- Responsible for management of the CDMO working closely with the drug sponsor technical team
- Issue escalation and on-site negotiation for all deviations, CAPAs and change controls
- Performing real time batch record review to ensure critical steps are appropriately documented
- Batch Records Review and Release
- Drives, leads, and troubleshoots quality investigations at contract manufacturers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.
- Oversee the execution of all experimentation under protocol ensuring CDMO is prepared to execute studies properly, ensure data gathering and testing meet client data integrity expectations for regulatory support
- Ensure contract manufacturers are compliance ready for regulatory inspections and monitor inspection progress during inspections.
- Measure and report on CDMO performance based upon drug Sponsors KPIs
- Ensure quality checks on on-going operations at contract manufacturers for:
- Oversight of physical product quality for the Excipient, Drug Product Manufacturing, Packaging & Labeling operations, and Materials Control
- Good Documentation Practices
- Adherence to approved Batch Record instructions & final release of manufactured products.
- Troubleshoot, with support from the Drug Sponsors organization all product quality defects related to the CDMO activity
- Manage competing priorities and allocate and assigned department resources at the CDMO to meet targets and timelines
QUALIFICATIONS
- Requires a bachelor s degree in the sciences (e.g. biology, chemistry, analytical or bio-analytical chemistry, engineering) with a minimum of 10 years of pharmaceutical experience in a GMP quality (QA/QC) environment with experience in Cell and Gene Therapy processing. An advanced degree in sciences would be a plus.
- Experience with Batch Record Review and Release (disposition).
- Strong experience with leading and managing quality investigations and Materials Review Board.
- Strong working knowledge of cGMPs (US, Canada, and Europe) requirements as applicable to both drug substance and drug products. Experience in investigational devices a plus but not essential
- Experience in managing contract manufacturing organizations and driving process improvements.
- Strong auditing experience on contract manufacturing organizations.
- Strong leadership and negotiation skills.
- Must have excellent verbal, written and interpersonal communication skills.
- Able to travel for 25% of time is required
- Wil require on-site presence for manufacturing campaigns
- Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is desirable but not essential
Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
