Executive Director, Analytical Development and Quality Control Lead

* Oversee recruiting and hiring of staff to support analytical development and Quality Control testing.* The site Analytical Development and Quality Control Lead has responsibility for all analytical support to the Wilmington Biotech Campus. This involves analytical support to clinical, validation and commercial activities.* The role assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as human resource management and spending are also responsibilities of the role.* The role will ensure that all necessary support is in place to facilitate laboratory start up and Health Authority approvals.* Strategic Quality Control oversight and leadership at the Wilmington Biotech Campus to meet functional and site goals and objectives.* Responsible for Quality Control related testing for the Wilmington Biotech Campus (Analytical, Biochemistry, Microbiology, Environmental Monitoring and Raw Materials).* Responsible for adhering to domestic and international CGMP regulations, company policies, leadership behaviors, performance and budget management.* Responsible for Quality Control oversight and compliance of laboratory related commissioning, qualification and validation activities.* Responsible for ensuring that the Quality Control laboratory test methods are qualified/validated as per corporate and site procedures.* Accountable for all Quality Control related documents which include Standard Operating Procedures (SOPs), Protocol and Technical Reports.* Responsible for ensuring laboratory investigations including OOS investigations are conducted in compliance with CGMP and best science.* Maintains all laboratories in an inspection-ready, CGMP-compliant state.* The role will lead the set up and management of the stability program for products manufactured at the Wilmington Biotech Campus and in support of the network.* In collaboration with Research and Development (R&D) support the transfer and validation of analytical methods and specifications for Biologics drug substance and drug product at the Wilmington Biotech Campus..* Provide site based analytical CMC information for filings and responses to queries from worldwide regulatory agencies to support marketing approvals for Wilmington Biotech Campus products.* Works with R&D to integrate Wilmington Biotech Campus activities into the analytical lifecycle ensuring that feedback is provided in both directions and risks are identified/mitigated to successfully meet analytical timelines.* In partnership with the Quality Organization, formulate and continually update appropriate CGMP procedures for the group, encompassing conduct of work, instrumentation, facilities and CGMP-regulated computer systems.* Ensure Quality Systems support the End-to-End Analytical Lifecycle and are continually audited/reviewed. Ensure new requirements are identified and implement.* Sustain performance through lean leadership, robust learning and development planning, organization talent reviews and communication planning.* Maintain training status in the department at the required level for roles and responsibilities of each job.* Responsible for development, promotion and compensation planning for staff.* Oversees the preparation of the departmental capital and expense budgets and operate within approved funds.* Significant experience in a comparable role; would typically have experience leading a functional area and contributing to the business at a directional, strategic level; ideally in an Analytical Development and/or Quality Control setting.* Proven ability to lead a QC laboratory team with >5 year experience.* Deep experience in analytical method development, validation and transfer in particular in the areas of high potent compounds and biologics products.* Deep understanding of the successful operation of a QC laboratory supporting release testing for multiple products across Chemistry, Microbiology and Potency.* Experience with relevant compendial guidelines, such as USP 1220, ICH Q2/Q14.* Knowledge of regulatory/code requirements to US and International Codes, Standards and Practices regarding analytical activity.* Understanding of business and operations management models and their application.* Recruitment and selection.* Experience in ADC and Biologics drug product and/or drug substance method validation and technology transfer.* Experience with release testing of clinical materials.* Laboratory experience in the management of potent and sterile drug products.* Experience with commercialization of ADC programs through PPQ and launch.* Drug substance/Conjugation analytical experience.* Excellent communication, presentation and interpersonal skills* Progressive people management skills* Negotiation skills* Demonstrable analytical and systematic problem-solving skills* Strong influencing skills* Business acumen* Proven financial management skills* Risk management skills**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr