Senior Process Engineer

Responsibilities

Own the process knowledge of the product(s) assigned throughout the development lifecycle, work collaboratively for comprehensive process mapping, maintain the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in a continued state of validation and continuously improving

Ensure the seamless flow of knowledge and information across functions, and with external stakeholders when applicable, with a focus on the assigned product(s)

Work to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across the manufacturing of cell therapies

Work as the Senior MSAT Process Engineer  on client projects

Responsible for technology transfer activities at the site level (within, inbound, and outbound), including any scale-up or other process adaptations

Lead technical transfer project team at site and liaises efficiently with involved internal and external functional groups as appropriate

Support development of manufacturing operations, including GMP system implementation and tasks related to GMP readiness 

Support Process Development and process comparability activities on Cellares technology as required 

Write and review relevant SOPs for manufacturing operations and systems, as well as batch records and BOMs

Support labor and equipment capacity modeling and participate in sales and operations planning process (S&OP) for supply review

Perform manufacturability assessments for new process introductions

Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies

Support our software team in developing a robust end-user solution for cell therapy manufacturing that integrations with external manufacturing processes and data management software including eBR, MES, QMS, ERP, and LIMS

Provide technical leadership to Manufacturing and other departments associated with GMP operations

Assess all major deviations including those that impact product quality 

Own root cause analysis investigations and discussions, including effectively liaising across the appropriate functional teams to drive resolution to major quality events and deviations

Propose and implement corrective and preventive actions (CAPAs) as necessary and own respective effectiveness checks to ensure recurrence was prevented

Own process-related change controls and change orders, from ideation and change control board review to implementation and effectiveness check

Facilitate and/or own the generation of process or operational-related Failure Modes and Effects Analysis (FMEA) and resulting mitigations and actions

Develop training and onboarding content and curriculum for new hires and new methods

Provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations

Maintain and report process run summaries and continued process verification reports

Prepare and present data associated with manufacturing processes to internal and external partners, as well as health authority inspectors

Support for process qualification and validation preparation, execution, monitoring, and reporting

Work with clients on process mapping of the manufacturing processes

Requirements

Bachelor’s Degree in a scientific or related field is required

A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy

Experience in the Pharma/Biotech industry in technology transfer

Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site

Adherence to cGMPs is required at all times during the manufacturing of Cell Therapy products. All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects, and related actions

Relevant experience bringing biotechnology equipment and processes from design through GMP operational readiness is a plus

Must have experience writing and reviewing GMP documentation

Strong analytical, problem-solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability

Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organization

Experience with Operational Excellence and/or Lean Manufacturing is a plus

Self-motivated and passionate about advancing the field of cell therapy

Self-awareness, integrity, authenticity, and a growth mindset

Desire to be part of a rapidly evolving organization with compelling technology and taking products and processes to the next level

Excellent planning, organization, technical writing, and time-management skills, including the ability to support, problem-solve, and prioritize multiple projects and deadlines