Katalyst CRO

Lead Quality & Validation Engineer

2 months ago

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Responsibilities

Provide quality oversight for drug product process technology transfers, including development and engineering activities to be leveraged.
Provide quality oversight for drug product process qualification/validation protocol, exception, and report reviews.
Provide quality validation oversight at contract manufacturing organizations (CMOs), including continued process verification (CPV), product quality reviews (PQR), supporting investigations and deviations as needed.
Adhere to regulatory guidance, policies, and procedures for technology transfer and process validation.
Independently coordinate and directly interface with multiple departments both internally and with our contract manufacturing and testing organizations.
Use risk management principles for qualification and remediation efforts.
Provide regular updates directly to Management.
Perform other related duties as assigned.

Requirements:

8-12 years of relevant experience and bachelor's degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred.
Direct experience in process qualification and validation using FDA and ICH guidance required.
Direct experience working with a CMO and drug product manufacturing preferred.
Must have in-depth understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally.
Experience in analytical method qualification and validation using FDA, USP and ICH guidance also preferred.
Knowledge of biologics/gene therapy processes desirable.
Able to execute complex concepts, techniques, standards and new applications based on quality principles and theories.
Able to implement solutions to complex problems, which require a high degree of ingenuity, creativity and innovation.
Demonstrates knowledge of industry best practices and trends.
Excellent verbal, written, and interpersonal communication skills are required.