Manager/Sr. Manager, Msat

We are seeking an experienced Process Engineer to join our new Manufacturing Science and Technology group and contribute to the commercialization of allogeneic NK therapies. This individual will lead/support various aspects of technology transfer, validation, and manufacturing support activities. They will work closely with internal and external partners to ensure the development and execution of a master validation plan, and the subsequent execution of process performance qualification (PPQ) runs and continuous verification activities; change management; initial setup of manufacturing and support of new manufacturing facility commissioning and qualification.

Responsibilities

• Collaborate with the Process Development team to ensure an appropriate process transfer with "facility fit" in mind, author and/or review Process Flow Diagrams, Bill of Materials, SOPs, Production Batch records

• As product pipeline advances clinically, support process characterization, process comparability, process control, PPQ and PV activities

• Provide guidance and applicable content for CMC regulatory submissions and ensure technical compliance with established conditions

• Support technical interactions with regulators for health authority inspections and post-approval CMC changes

• Lead/support Manufacturing Ops team to ensure safe, quality, and timely manufacture of products for pre-clinical, clinical and commercial use

• Provide support for deviation investigations, development of CAPAs and change controls

• Troubleshoot activities for the production processes with the objective to guarantee that the product is delivered in time, and meets quality standards

• Identify continuous improvement opportunities through manufacturing process monitoring and trending

• Ensure that all tech transfers into manufacturing operations are controlled and executed within GMP regulatory guidelines and with appropriate training

• Drive strategic operational resource and capacity planning

• Collaborate with Quality colleagues to ensure high-quality product and timely resolution of Quality items: deviation management, change management and CAPAs

• Partner effectively with counterparts at CDMOs and key suppliers to meet goals of reliable, robust manufacturability and high product quality including tech transfer and scale-up including process facility-fit assessments including Failure Modes and Effects Analysis (FMEA)- and Risk Assessments

• Drive understanding of QbD approaches and implementation of creative problem solving

Qualifications

• Bachelor's Degree in science or related discipline is required

• 3+ years of MSAT biologics experience required, viral vector, cell and gene therapies experience highly desirable

• Experience with technical support of clinical and commercial biological products and cGMP manufacturing

• Extensive knowledge of US and EU cGMP regulations/guidance and experience with regulatory agency inspections desirable

• Extensive experience with technology transfer, process validation and process monitoring

• Direct experience working with contract manufacturing (CDMO) and/or technical service partners

• Technical experience supporting manufacturing quality compliance including deviations, change controls and CAPAs

• Experience with developing CMC content and knowledge of regulatory guidance and trends

Salary and Benefits

• Compensation for this role includes base salary, annual target bonus and equity

• The base salary range for this role is $140,000-$171,000. Starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity

• Significant growth opportunity as the company expands

• Empathetic, supportive and collaborative colleagues and work environments