General Company Description
Resilience (Resilience US, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.
For more information, visit www.resilience.com.
Position Summary & Role (general description of the role; e.g. expectations, key milestones, impact)
Reporting to the Head of Technology, the Senior MSAT Process Engineer will provide technical support for drug substance and drug product production of Gene Therapy / Vaccines commercial and clinical products at the Marlborough, MA. The Senior Process Engineer will partner with Process Development, EHS, Quality, Manufacturing, Engineering, Digital and global groups to ensure compliance and collaboration, and help support the development of the Resilience Network.
The responsibility of this role will rapidly expand to help build the local MSAT team by onboarding and mentoring additional process engineers.
MSAT is responsible for:
- Leading the introduction of new manufacturing processes and/or new technologies to the Marlborough site including drug substance and drug product for all phases of GMP manufacturing.
- Supporting manufacturing operations, assess deviations and investigations for product or process impact.
- Performing process trending and monitoring.
- Identifying and driving implementation of improvements to maximize throughput and capacity utilization.
- Reviewing and approval of Change Controls.
- Authoring process & product related documentation (SOPs, master batch records, protocols, reports, specifications, etc) and risk assessments.
- Defining relevant operational/technical standards and practices for the site.
- Providing support and content for regulatory submissions.
- Supporting Health Authority inspections.
- Supporting Client Interactions.
The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved.
- Provide front line technical support to GMP operations in a multi-product and multi-modality SUT facility manufacturing for clinical and commercial products. Provide technical expertise in both cell bank manufacturing, Drug Substance and Drug Product manufacturing.
- Lead tech transfer efforts and support activities through process validation including facility fit and risk assessments.
- Collaborate with manufacturing as well as all support functions such as engineering, quality, and supply chain to provide robust and coordinated support.
- Develop Bill Of Material, Specifications, Standard Operating Procedures, Work Instructions, trainings and forms to support implementation of new processes.
- Function as a technical resource for the resolution of deviations, investigations, and process issues. Complete technical investigations and provides on-the-floor technical expertise.
- Generate technical documents (memos, protocols, reports, plans, etc.,) related to process validation, change controls, technology transfer, process monitoring, process improvements, etc.
- Complete process monitoring tasks that require a variety of statistical and data analysis methods and techniques (e.g., excel, JMP, etc.).
- Be a technical resource in the evaluation and implementation of process improvements, policy changes, compliance improvements and optimization programs including new technology.
- As the site grows, the candidate will help build a MSAT team.
- Actively participate in client meetings and serve as a technical SME.
- Comply with safety requirements and work to resolve any environmental, health and safety issues.
- M.S./B.S. in Life Sciences, Chemical or Biological Engineering, or related discipline with ≥ 12 years of relevant industry experience in process development, technology transfer, or GMP Manufacturing. Understanding of quality, compliance, regulatory, and good manufacturing practices.
- Embodies the Resilience phenotypes of grit, quality + rigor, service orientation, EQ+IQ, builder mentality, velocity, and ownership.
- Ability to problem solve, think critically, and troubleshoot while working independently.
- Hands‐on experience in the scale up and operation of large-scale biotechnology processes using single use technology. Experience in cell banking.
- Experience working for or with contract manufacturing organizations.
- Experience owning, managing, and executing change controls and using management systems (ex. Veeva).
- Thorough understanding of FMEA, risk analysis, process characterization and process validation of biologicals. Extensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization is preferred.
- Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across functions and multiple stakeholders.
- Project Management skills.
- Ability to influence others without direct authority and communicate with all levels of the organization.
- Excellent communication (oral and written) and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners..
- On site work required for position
- Support 24/7 production/manufacturing activities, which may require off-shift work on occasion including weekends.
- Ability to gown and gain entry to manufacturing areas