Process Engineering Tech I - Gaithersburg, MD, United States - Cartesian Therapeutics, Inc.

Description

We are seeking a Head of Process Engineering to join the Manufacturing, Science and Technology (MSAT) team and support ongoing process development, manufacturing of GMP grade material for company's Phase 1 and 2 clinical trials, technical transfer from preclinical to clinical Phase 2, IND authoring and agency interaction activities.

In particular, this role will focus on optimizing the GMP manufacturing platform for company's all clinical assets.

The candidate will work with Chief Technology Officer to lead authoring the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met.

The candidate must have a proven track record in supporting the development, scale-up, registration and manufacture of cell therapy processes.

The candidate must also excel in communication and collaboration, as this role requires many interfaces both internal and external to Cartesian.

The successful candidate will also be comfortable with change, being flexible to deal with shifting landscapes and new challenges.
GMP Manufacturing for Phase 1 and 2 clinical trials
Oversee the process engineering team for successful manufacturing of company's clinical
Be accountable to successfully deliver CMC chapters to regulatory documents
Develop and execute processes to ensure data integrity
Identify and close technical/content/compliance gaps
Collaboratively work across the broader CMC, regulatory and quality departments to deliver desired outcomes (including external vendors when applicable)
Actively support dialogue/interaction with regulatory agencies
Regulatory Compliance
Stay up to date on relevant regulatory requirements and guidelines related to biologics process development and manufacture
Ensure all activities comply with Good Manufacturing Practice (GMP) and other applicable regulations.
Risk Management
Identify potential risks and challenges within the development and filing history of products and develop mitigation plans
Oversee relationships with external vendors (where applicable), including CRO's, consultants and technical services

Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CRO's/CDMO's.

Participate in project team meetings to provide updates on subject matter status and address any issues or concerns.
Bachelor's degree in a relevant scientific discipline; Minimum 15 years' experience in process engineering, supporting the process development, scale-up and manufacture of cell therapy processes at a pharma, biotech or contract development and manufacturing organization (CDMO)
Experience with all phase drug development, control strategy, validation and authoring/reviewing associated regulatory submissions
Broad understanding of regulatory and GMP requirements for all phases including /commercial
Strategic thinker, ability to identify and prioritize action to maximize value and minimize risk over the mid to long term
Project management skills, tools, principles, and applications
Proficiency in relevant software applications
Nimble in a highly dynamic and agile organization
A promotor of inclusion and collaboration
Able to handle multiple projects simultaneously while maintaining high-quality results
Technically proficient in industry standard technology and/or available software, processes, and industry trends to streamline and or improve efficiencies
The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory.

The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat.