Manager, Process Development - CARMA Cellular Therapies

Location
Gaithersburg, MD, United States
Posted
Nov 17, 2020
Ref
247629323
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time
About CARMA Cell Therapies :

CARMA Cell Therapies, Inc. is a wholly owned subsidiary of MaxCyte, Inc. focused on advancement of novel mRNA - based cell therapies for cancer and other diseases with serious unmet needs. MaxCyte has developed CARMA, a novel and proprietary platform for the development of non - viral, human messenger RNA (mRNA) - based, chimeric antigen receptor (CAR) or T - cell receptor (TCR) redirected immune cell therapies. CARMA [derived from CAR mRNA] utilizes MaxCyte's Flow Electroporation® technology for highly efficient, non - viral, delivery of one or more mRNA(s) into non - activated peripheral blood mononuclear cells (PBMCs) or isolated immune cells such as T - or NK - cells. CARMA offers the potential for a safer cell therapy, as a result of transient expression of receptor(s) and a non - viral delivery approach. Together, CARMA and MaxCyte's EXPERT™ family of instruments also offer the potential for a significantly streamlined, scalable, and cost - effective GMP manufacturing process without the complexity of virus - based product s. At the start of 2020, MaxCyte established CARMA Cell Therapies as a wholly owned subsidiary to facilitate independent investment and new partnerships to advance the CARMA platform. The Company expects CARMA to be self - funded by 2021.

Job Summary:

The M anager, Process Development position plays a key role in developing and optimizing the clinical manufacturing processes for CARMA cell therapy products. The Process Development Manager manage s relationships and deliverables from other functional groups as it applies to process development , the d esign and execut ion of process development and scale - up experiments , and the transfer of processes to Contract Development and Manufacturing Organizations (CDMO). 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 departmental and company goals.

Job Responsibilities:

• Designs and executes process development and scale - up experiments to support cell isolation, culture, RNA transfection and cryopreservation processes for autologous immune cell therapy products .
• Est ablishes plans and protocols to develop, troubleshoot, oversee , and support efficient technology transfer of CARMA manufacturing processes to and from the CDMOs and other partners .
• Collaborates with Manufacturing Operations to develop, optimize, and implement new technologies that may benefit CARMA Manufacturing.
• Collaborates with Analytical Development to develop and optimize product - specific analytical test methods to support in - process testing, product characterization, final product release and com parability .
• Contributes to the preparation of regulatory filings as Subject Matter Expert (SME) in process development. Provide data summaries to support other global regulatory activities .
• Provides technical support as needed to help troubleshoot Chemis try , Manufacturing , and Control s ( CMC ) related issues .
• Maintains up to date knowledge of manufacturing trends and provides recommendations regarding manufacturing process improvement initiatives .
• Contributes to cross department al activities as needed, by providing technical input where required. Prepares and reviews technical documents for patent applications, regulatory authorities and external contractors and collaborators.
• Develop s , revise s, and review s SOPs, protocols , and process development and tech nical reports .
• Maintains appropriate level of documentation throughout the entire development process and follows Good Documentation Practices .
• Collaborates and manages relationships with cross functional internal and external stakeholders including R esearch and Development (R&D) , Manufacturing Operations, Quality Assurance (QA) and Analytical Development (AD).
• Provides technical and strategic input and drives continuous improvement to the manufacturing process through technological innovation to suppo rt ongoing product development effort s by conducting appropriate tests, experiments and qualification studies to justify proposed changes.
• Prepares, reviews , or edits regulatory filing documents and provides responses to questions from US and ex - US health authorities as an SME in process development.
• C omplies with all applicable laws and Company policies regarding health, safety, and environment.

Job Requirements:

• Master 's degree in Life Sciences or closely related discipline with a strong background in biology/immunology. Bachelor 's degree with requisite experience also acceptable.
• 7+ years of experience working in cell/gene therapy , ideally with the majority of that time in process development .
• Demonstrated experience with manufacturing automation and t echnologies for cell isolation, purification, concentration and cryopreservation.
• Working knowledge and experience with isolating, purifying, culturing, and cryopreservation of PBMCs, T cells and NK cells.
• Strong quantitative, qualitative, and critical thinking skills and abilities. Ability to a dapt to changing needs as experiments develop or priorities change .
• Proven experience working with and handling RNA. Experience in mRNA and/or Oligonucleotide synthesis is a plus.
• Working knowledge of a nalytical instrumentations and test methods, such as qRT - PCR, F low Cytometry , ELISA and immunological assay is strongly desired.
• Working knowledge of Quality by Design (QbD) is desired .
• Strong troubleshooting skills with the ability to "think outside the box" .
• 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 .
• Results oriented. Ability to multitask, prioritize work and adapt in a constantl y evolving, fast - pace environment with minimal supervision. Solid knowledge of regulatory requirements. Must have working knowledge of pharmaceutical GMP's and ICH guidelines .
• Outstanding written and oral communication skills are essential; ability to present thoughts clearly and concisely .
• Ability to effectively collaborate with and lead vendors, customers, colleagues, and direct reports across teams. Detail oriented with proven leadership, organization and project management skills.
• Demonstrated compute r skills; experience using MS Office and other data analysis software and other related applications . MaxCyte, Inc. is an equal opportunity employer.