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.