Position Overview The primary focus of the QC and Analytical Development Manager Associate Director is to oversee the Quality Control QC operations at the Contract Development and Manufacturing Organization CDMO in support of product testing and release In addition this individual will provide technical expertise and oversee as needed method development and optimization as well as method transfer to and from CDMO collaborators and partners to ensure robust analytical method GMP and ICH compliance are maintained We are seeking a demonstrated leader with the breadth of professional experience and drive to work effectively with both internal and external partners in a highly matrixed and cross functional organization with a tactical focus on meeting the scientific clinical analytical and business requirements of the department in line with company goals Responsibilities Oversight of CDMO QC operations to support Vita s Clinical Studies Review and approve QC data from cGMP manufacturing campaign for lot disposition Perform technical QC review and support QC nonconformance or Out Of Specification OOS investigations Provide QC Analytical training Assist with CAPA implementation and change control activities Manage stability studies program Execute assay analytical method development projects to support current clinical study as well as future pipeline Provided as needed MSAT support Assist with CAPA implementation and Change Control activities at Vita CDMO or Contract Testing Laboratory Provide lab oversight and management of Vita s internal PD Analytical Development Lab Support activities related to the transfer qualification and validation of analytical methods Develop revise and review SOPs protocols and technical reports Evaluate analytical instrumentation to support ongoing analytical method development initiatives Evaluate back up contract testing laboratories Provide as needed support and contributions to IND filing regulatory submission as well as audit or inspection support as the technical SME Complies with all applicable policies regarding health safety and environmental policies Others Requirements Bachelor's degree in Life Sciences or closely related discipline with a strong background in biology immunology 5 years of experience working in cell gene therapy or biopharmaceutical industry Experienced working and managing CDMO and Contract Testing Laboratory Extensive industry experience with externally facing roles with relevant hands on experience in analytical techniques including but not limited to Flow Cytometry IHC Real Time PCR ELISA Cell Viability measurement etc Experience in performing analytical method development qualification validation and support method transfer activities Familiarity with FDA ICH and cGMP guidelines Thorough understanding of cutting edge analytical tools and technologies Strong quantitative and qualitative analytical abilities Ability to think critically and demonstrate troubleshooting problem solving skills Self motivated with a strong sense of ownership in areas of responsibility Excellent organization time and project management skills Ability to multitask prioritize work and adapt in a constantly evolving fast paced environment with minimal supervision High energy level and a positive outlook coupled with the requisite can do attitude Willingness to do what it takes to achieve organizational goals and overcome obstacles Excellent interpersonal verbal and written communication skills including the ability to initiate and contribute to discussions and build strong relationships are essential in this highly collaborative and matrixed work environment Demonstrated computer skills experience using MS Office and other data analysis software and other related applications Strong Microsoft office skills are required specifically Outlook Word Excel and PowerPoint Vita Therapeutics is an equal opportunity employer committed to giving all qualified applicants consideration for employment without regard to race color religion sexual orientation gender identity military veteran status or national origin Applicants must be currently authorized to work in the United States on a full time basis Vita does not accept unsolicited agency resumes WMv RiD k4q