Director, CMC

Company: AISES
Location: Waltham
Posted on: September 12, 2020

Job Description:

Mana Therapeutics is an exciting, dynamic start-up developing a potent cell therapy platform that will provide an “off-the-shelf” (or allogeneic) alternative for patients with solid and liquid tumors. Our diverse team of scientists, physicians, and business associates are passionate about harnessing the natural immune system to develop cell therapies without the need for genetic modification. We’re building a place of collaboration and camaraderie where collective hard work without egos or pretense enables breakthroughs that translate science into impact on human lives. This is an opportunity to join a growing and innovative cell therapy start-up that can provide you an exciting, creative career path while helping us evolve into highly successful organization.

Summary of role:

This is a highly visible role that will report directly to the Chief Technology Officer. You will be a leader within the CTO functional team responsible for technical execution of process and analytical development, technology transfer, and manufacturing operations for off-the-shelf targeted T-cell therapies for cancer. You will be responsible for design, execution, and reporting of studies in Mana labs or collaborator/CDMO labs to facilitate development and execution of robust, scalable, processes for cGMP manufacture in support of Mana’s clinical trials. You will participate in the evaluation/implementation of a new manufacturing and analytical technologies to scale-up/automate current processes; or to enhance process and product attributes that support path forward toward commercial translation of current process and clinical translation with NextGen processes.

Responsibilities

Responsible for design and execution of scientific studies pertaining to process and product characterization and scale-up; including the detailed experimental protocols incorporating relevant and sensitive analytical methodologies; at Mana’s internal Process Development laboratories, and at collaborator laboratories and/or at CDMO sites.

Maintains detailed records; and analyzes and interprets results from all scientific studies and writes technical reports to support publications / presentations, quality requirements, regulatory submissions, any intellectual property filings.

Represents Mana and leads technical interactions with all stakeholders and assists Quality with root cause analysis related to deviations, discrepancies, and out-of-specifications in GMP manufacturing operations at multiple CDMO sites.

Builds Mana’s internal CMC laboratories to provide MSAT support to CDMOs with activities pertaining to process scale-up and characterization.

Defines objectives and deliverables for process and analytical methodologies for activities of R&D team, to permit qualification and validation of manufacturing processes and test methods

Contributes to Mana’s laboratory procedures; equipment and reagent upkeep and maintenance; and participates in routine laboratory operational and safety related duties in the Process Development lab.

Serves as a subject matter expert on CMC aspects related to Dendritic Cell and T-cell biology and function; and maintains current awareness of developments and analytical methodologies in relevant scientific fields and evolution of regulatory standards thereof.

Represents Mana in the scientific community; and leads data presentations and scientific discussions at scientific meetings and conferences.

Experience with writing regulatory sections for IND filings is desired.

About our science :

Mana Therapeutics is bringing immune cell therapies to cancer patients with high medical need through the use of its proprietary EDIFY TM platform. We are focused on unique ways of educating endogenous healthy donor-derived immune cells, without need for viral vectors or gene editing. Mana T-Cell products recognize multiple proteins that are over-expressed by tumor cells. This approach creates off-the-shelf allogeneic tumor-associated antigen-specific T-Cell therapies that eliminate cancer and deliver greater breadth, more durable response, and improved safety relative to existing or other experimental therapies.

Mana Therapeutics is an Equal Opportunity Employer (EOE)

Requirements

Requirements:

PhD in Biochemical Engineering, Cellular Immunology or related disciplines with 7-10+ years of experience, and relevant hands-on work experience with strong knowledge of the process and analytical characterization of cellular therapy products and translation to clinic.

Prior hands-on experiences with large scale cell isolation, cell culture, multi-parametric flow cytometry, various immunological functional assays is must.

Experiences with management of technical activities and analysis/interpretation of results to manage technical execution at external CDMO groups is required.

Experiences in assessment of process and analytical technology platforms and requirements for qualification/validation of processes to demonstrate robustness and scalability is required.

Key to success:

Detail oriented and objective data analytical abilities with excellent communication skills

Ability to work independently, as well as in a collaborative environment to meet project goals with attention to detail, and with excellent written and oral communication skills

Enjoys solving challenging scientific questions in a fast pace, multi-disciplinary, matrixed structure within a start-up environment

Job Information

Job ID: 54572565

Position Title: Director, CMC

Company Name: Mana Therapeutics

Job Function: Engineer

Job Type: Full-Time

Job Duration: Indefinite

Min Education: Ph.D.

Min Experience: 7-10 Years

Required Travel: 0-10%

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Keywords: AISES, Waltham , Director, CMC, Other , Waltham, Massachusetts