Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Paragon’s scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch.
The Manager, Quality Control - Raw Materials will be responsible for overseeing the Raw Material program for clinical (phase I-III) and Commercial operations across two manufacturing facilities including people leadership for all analysts within the raw material team. Opportunities to continuously improve QC sampling and associated processes including the evolution of team skills for optimum results.
Position does require travel back and forth between the BioPark and BWI Manufacturing facilities (approximately 12 miles)
Key responsibilities include but are not limited to:
- Oversight and maintenance of Paragon’s quality control raw material sampling and release program, including oversight of sampling, coordination of internal and external testing and review of contract lab test results
- Participates and carries out continuous quality improvements in the QC sampling area
- Ensures compliance with cGMP and safety requirements within QC
- Schedules and provides technical oversight of microbiological testing performed internally and externally sourced supporting GMP manufacturing and Pre-Clinical activities and studies
- Participates in project specific, system, client, and vendor audits
- Participates in internal audits of GMP QC data and records, monitoring files and study files. Reviews new and executed documents for compliance to stated Paragon SOPs, formats and regulatory requirements (especially protocols, deviations, investigations, amendments, etc.)
- Writes and/or reviews Paragon’s SOPs pertaining to Quality Control raw material operations
- Conducts training on applicable SOPs, regulatory requirements and quality initiatives
- Provide input to quality metrics specific to the raw materials program
- Maintains QC sampling areas in an audit ready status at all times
- Acts as technical QC raw material SME in support of client needs and projects and during third party inspections/audits
- Works closely with Quality Control and Material Control for coordination of raw materials for sampling and testing. May also interact with Project Managers on raw material coordination
- Flexibility in following unique campaign requirements that may include off-hour and weekend work
- Establishes and revises material specifications in accordance with current compendial chapters/monographs and updates as well as client specific requests
Education & Experience:
- Bachelor's or Master's degree in a life science field required.
- 10 years experience working in a pharmaceutical or biotechnology organization with at least 5 of those in a GMP Quality Control role required. Raw Material familiarity required.
- Experience developing/establishing a raw material program preferred
- 4 years direct people leadership required
- Experience with American National Standards: Sampling Inspection and Tables for Inspection by Attributes (ANSI/ASQ Z1.4-2003 R2018) Table I and Table IIA for General Level II / Normal Inspection preferred
- Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidances (US and EU)
- Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.
- Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversally collaborative) across functional groups and levels.
- Ability to analyze information and solve problems relating to Quality Control.
- LIMS experience preferred.