Technical Product Lead

Job Summary

The Technical Product Lead will be the primary point of contact for the customer on all technical matters for their program(s). This position requires a deep CDMO/GMP knowledge, highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment

Responsible for contributing to key functional, tactical, and operational aspects of the Memphis CDMO site. This includes approval & oversight of MS&T activities associated with execution, tech transfer, QMS documents and other documentation related to operations. Responsible for evaluating process details including technical ability to evaluate & approve these details in the quality management system. The individual will perform activities in support of tech transfers and routine operations while ensuring compliance with directives and procedures, customer requirements, and regulatory standards. Leads, as applicable, meetings focused on quality items, product-related projects, test method transfers, validations, and customer related topics.  

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•    Develop and shape a best in class technical experience for clients by executing timely and effective responses and corrective actions for quality topics
•    Ensure strategic alignment with deliverables by leading execution efforts across key internal and external stakeholders
•    Apply advanced problem-solving strategies to optimize processes and fulfill client expectations
•    Coordinate inputs from clients and internal functional team from work statement approval through to project completion
•    Provide specific technical knowledge for the Quality Unit organization (participating on investigations, studies, and trending evaluation as well as innovation and continuous improvements projects) 
•    Delegate tasks within the MS&T and operations function and drive progress to completion during execution to the required standard (internal and customer’s) and ensure on-time completion of deliverables
•    Attend and participate in client meetings, Tech Transfers, and other related meetings in support of client projects
•    Collaborate to ensure that tasks are prioritized, completed on time, and communicated in an effective and timely manner
•    Perform, review, approve (as applicable), and follow up tech transfer documentations related to the different customer´s projects
•    Review the monitoring of manufacturing processes
•    Review and approve (as applicable) Protocols, Studies and Reports. 
•    Review and approve specifications for each specific customer as applicable
•    Review and approve process sampling plans and process descriptions
•    Develop and implement reporting to track key metrics quickly identifying trends to drive proactive resolution in compliance with internal and external guidelines, standards, and regulations
•    Build trust and influence within different departments of the operation by being a top technical advisor to Operators and Clients.
•    Ensure regulatory and customer inspection readiness and represent the applicable departments in audits as required
•    Participate in client and regulatory audits

Job Qualifications

•    Bachelor's degree required. Master's degree preferred.
•    Minimum 10 years of related industry experience and 5+ years of leadership experience
•    Experienced with CDMO business and/or gene-modification modalities, cell-based gene therapies.
•    Understanding of US and EU cGMP guidelines and requirements
•    Ability to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc.) to functional area leadership
•    Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment
•    Ability to understand operational documents for GMP compliance, accuracy, and completeness
•    Ability to work by influencing a matrix management system and to gain the cooperation of others
•    Strong client-facing interpersonal skills coupled with a concern for impact
•    Strong time management and organizational skills
•    Excellent written and oral communication skills both internal and external
•    Able to manage multiple priorities and demonstrate self-control
•    Ability to resolve conflict within project teams
•    Exhibit good leadership skills
•    Strong attention to detail
•    Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community
•    Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential.
•    Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies.

•    2 plus years in developing and maintaining budgets at a department level
•    3 plus years leading projects that involve multiple departments and outside organizations
•    PMP certified is a plus

The starting pay for this position is $143,500 - $158,600k.  Please note that starting salaries vary based on factors including, but not limited to experience, skills, education, certifications, and locations.