Job Title: Executive VP of CMC
Job Number: 24962
· Responsible for successfully driving the product development program forward while exercising sound scientific judgement and meeting regulatory, budgetary, and timeline restrictions.
· Responsible for process development with support of contract manufacturing organizations (CMOs) as applicable to satisfy stage of development and corporate goals.
· Responsible for the compliant, cost effective, and timely manufacturing of clinical and pre-clinical trial material. Will work with pre-clinical and clinical team to project material needs and establish supply chain for clinical trial materials.
· Responsible for the oversight and control of quality of clinical and pre-clinical trial material.
· Responsible for the implementation of stage appropriate analytical methods and protocols and ensuring alignment between contract research organizations (CROs) and CMOs and regulatory standards.
· Responsible for building strong relationships and managing contract development organizations and other partners in the clinical supply chain through frequent, clear, and transparent communication. Identify and select contract manufacturing organizations (CMOs) where applicable.
· Responsible for managing the product and process development and manufacturing budget.
· Responsible for project planning as it relates to the CMC business functions, work with the rest of the executive team in setting goals in line with overall company goals and objectives, and evaluating outcomes.
· The EVP will work with the executive team in strategic, financial and operational planning for the company.
· Provide technical and quality thought leadership in the preparation of regulatory submission documents. Assist in preparation of regulatory submission documents.
· Prepare and deliver presentations to the board as needed.
· The EVP will provide technical and quality leadership to the company operations and be an instrumental part of the executive team.
Inspirational leader with innate ability to build relationships with partnering organizations through strong character, authentic leadership, transparent and direct communication.
Vision and strategic big picture view with a first-hand understanding for all levels of company operations.
Deep expertise in enzyme expression in bacterial fermentation processes, manufacturing operations, quality management, and CMC (chemistry, manufacturing and controls) with the clear desire and a growth mindset to continue learning at a fast pace.
Excellent scientific, analytical and problem-solving skills with ability to use sound scientific principles and concepts in reasoning and discussion.
Extremely resourceful, critical thinker, with a solution-orientation that overcomes barriers with good judgement and moral character.
Need to exhibit a sense of urgency in accomplishing tasks and expect and encourage the same from partners and team members.
Demonstrated ability to manage budget and continuously find ways to decrease cost.
Exceptional sense of organization and attention to detail, in particular as it relates to technical and manufacturing documentation and CMC sections of regulatory filings.
Ability to effectively delegate as well as execute by own means as applicable.
Work alongside community leaders, executive directors, government officials and senior board members.
Very strong oral and written communication skills.