Associate Director/Director is responsible for testing oversight of Analytical, Biochemistry, Raw Material, Microbiology and Analytical Sciences & Technology (AS&T) functions at the Quality Control Laboratories. The labs are responsible for in-process, release and stability activities. Additional function responsibilities include sample management, instrument troubleshooting, maintenance, qualification, data review in support of the daily lab operations.
Key Duties and Responsibilities
* Oversight of daily laboratory operations, including leading the effort in managing and overseeing analytical method validation and transfer
* Provides leadership in developing a comprehensive analytical testing, investigation and characterization strategy
* Provides Collaboration to design and manage the product release testing and stability programs, recommends product specifications, and participates in analytical instrument vendor qualification and management
* Directs lab operations and manages analytical, biochemistry, microbiology, and sample management groups to ensure timely testing
* Leads the Analytical Sciences & Technology staff members for method transfer-method validation, instrument management, lab systems development, data review, and instrument qualification. Establishes user requirements for qualification of QC analytical equipment. Works with internal and external resources to maintain equipment in an optimal state.
* Responsible for directing OOS, lab investigations and lab trending procedures
*Manages the routine record review of test data and related documents for in-process testing, drug substance and drug product release . Generation CoAs for product release
* Responsible for the development and deployment of the stability program for commercial products
* Supports and oversees the in-process and final product specification system for fraction intermediates, bulk drug and finished products manufactured at company.
* Monitors the GMP systems currently in place with the laboratories to ensure compliance with policies
* Managing, designing, and implementing lab systems relating to raw material testing, in-process and finished product testing, in addition to microbiology monitoring programs
* Maintaining and improving quality metrics that incorporate continuous improvement methodologies
* Facilitating, approving and providing inputs into lab investigations, and non-conformance reviews.
* Supporting the Annual Product Quality Review process, in addition to providing product trending
* Develops standard Operating Procedures to ensure compliant lab operations across the manufacturing site
* Implementation and management of lab related data integrity procedures and the lab information management system, Maintaining QC programs, Policies, processes, procedures, and controls ensuring that analytical testing of products conform to established standards and agency guidelines
* Works collaboratively with cross-functional teams and responsible for supporting decision making on product quality/compliance matters
* The incumbent will be responsible for handling multiple projects, demonstrate effectiveness in task completion with effective problem solving and critical thinking.
* Mentors Quality Control personnel and enable their individual growth
* Gathers metric information for use in continuous improvement of areas of responsibility
* Acts as subject matter expert for the QC lab operations during audits and regulatory inspections
* University Degree (BS/MS/PhD) in relevant Science discipline( Biology, Biochemistry, Chemistry, Microbiology)
* Minimum 15+ years experience in managing Quality Control laboratory function; at min 10 years of people management experience
* Background in the analytical, biochemistry and microbiological testing of Protein Biologics or Plasma Fractionation is required
* Well versed in various analytical techniques and applicable methods specific to the testing of plasma derived therapies or biopharmaceuticals
* Advanced knowledge in related laboratory quality systems, data integrity and regulatory requirements (21 CFR Part 11/210/211)
* Diverse instrumental analyses, pharmaceutical, microbiology (endotoxin, bioburden, sterility testing) coupled with broad technical understanding and ability to apply skills/knowledge new technology
* Expertise in GMP compliance, Health Canada and FDA regulations
* Experience with start-up, implementing and overseeing laboratory operations and deploying related quality systems is required. Strong knowledge of GMP, Laboratory system SOP's and quality control processes
* Demonstrated experience building and leading exceptional teams is required
* Demonstrated excellence in written and verbal communication
* Demonstrated ability to work cross-functionally and to develop and maintain strong partner relationships
* Demonstrated ability to work as a senior management team member and to engage and influence team members in a startup environment
Job Types: Full-time, Permanent