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Sr. Operations Engineer, Nucleic Acids and Plasmid Operations

Summary

The Sr. Operations Engineer will play a key, hands on, cross-functional role in translating process design to operational execution.Planning, scheduling, and the coordination of direct and supporting activities to ensure a successful operation will be required. This role will facilitate operational coordination across and collaboration with internal and external key stakeholders to drive results, deliverables, and timelines for internal projects and initiatives. This role will support effective implementation of policies, best business practices, and processes, and procedures.

In addition to operational standup and execution, this position will mange the establishment and improvement of operational metrics via continuous improvement.This will include oversight of cross-functional workstream including but not limited to Process Development, Quality, Procurement, Finance, and Facilities/Engineering. This is a critical role with oversight for the implementation of operational excellence strategies to optimize operational efficiencies with a data-informed and metrics-based approach. This position will influence strategy execution based on the data reporting, KPI management, and process redesign and improvement

Responsibilities

·Provides operational coordination across a cross-functional team for internal projects in laboratory services, supply chain, quality, IT, facilities and engineering, and client project management

·Collaborates with internal and external key stakeholders to drive results, timelines, and deliverables for a portfolio of projects and initiatives within budget

·Supports the efficiency of existing processes and procedures to enhance and sustain internal capacity

·Ensures timely and effective communications within the business unit

·Executes against an operational process design and reports back opportunities, challenges, and gaps

·Supports change management and continuous improvement efforts

·Helps monitor, and interpret operational metrics to drive efficiency and improvement projects

·Participates in interpretation, analysis, and actionable improvements

·Adheres to cGMP compliance and leads efforts to seamlessly integrate compliance into business processes

·Contributes to and supports technical writing efforts, including but not limited to drafting, editing, and improving SOPs that meet both compliance requirements and foster best business practices

·Helps foster a high performing cross-functional, matrixed team through collaboration, communication, time management, and accountability

·Build and maintain data collection, management, and reporting systems across cross-functional systems

·Manage metrics, dashboard, and scorecard reporting

·Diagnose and drive data-based improvements across processes through data analysis, Gemba walks, process monitoring, and employee interviews

·Work with leadership to develop tactical implementation plans across workstreams

·Work with leadership to plan and build capacity and capability, identify operational efficiencies, cost savings, and reduce process waste

·Work with training and leadership teams to execute on operational excellence capabilities for testing teams

Help set up and manage robust and effective communication systems

Education & Experience

·Bachelor’s degree in science or engineering required. Master’s in science or engineering preferred

·5+ years of cross-functional experience in biotechnology with a strong understanding of operational excel, continuous improvement, Lean Six Sigma and project management is preferred

·Lean Six Sigma Certification preferred

·Excellent data analysis, reporting, and organizational skills

·Independent thinker with a track record of working collaboratively in a matrixed environment to achieve goals

·Highly functioning, process-oriented, and self-starter mind-set required

·Experience with cGMP, ISO regulated environment is required

·Excellent attention to detail with strong documentation, communication, and data presentation skills

·Must be able to thrive in a fast-paced, startup environment with tight deadlines

August 9, 2022

Associate Director, Plasmid/Nucleic Acids, Process Development

Summary

This role is responsible for leading and overseeing mRNA and plasmid operations including in vitro transcription, microbial fermentation and purification process development. The position has responsibility for technical product lifecycle management in the nucleic acids asset pipeline.The ideal candidate will help design and startup a nucleic acid process development laboratory to support plasmid DNA production and mRNA synthesis. The ideal candidate will lead the process development and scaleup mRNA, plasmid DNA, and other nucleic acid assets. Experience in Microbial Fermentation Upstream and/or Purification Process development and optimization is a requirement. This position works closely with internal and external stakeholders to deliver technical documents such as reports, protocol, and data reviews. During the clinical/commercial manufacturing preparation phase, this role will serve as a senior leader for the delivery of key product development and tech transfer deliverables.

The primary responsibility of this candidate is to develop a scalable end to end plasmid production platform, support technical transfer/scale-up activities, and troubleshoot technical nucleic acid production. The scientist will also collaborate with both external and internal stakeholders to support ancillary activities such as analytical testing, cell banking, process scaleup, and technical transfer.In addition to the technical skills required, this role will be held accountable for technical protocols, reports, batch records and SOPs. The ideal candidate will successfully demonstrate upstream and downstream process development, scaleup, and analytics. Personal attributes including independent thinking, having a self-starter mindset, and strong collaboration skills are required. This leadership role will defined the process development strategy for nucleic acids, and previous management experience is preferred.The final level of this position will be set according to candidate experience and qualifications.

Responsibilities

·Designs and implements microbial strategies for upstream and downstream process development

·Experience in developing, executing, and optimizing of upstream (fermentation, scale-up, characterization) and downstream (centrifugation, chromatography, and tangential flow filtration) unit operations

·Leads process development studies and reviews technical data and documentation

·Supports technology transfer into GMP manufacturing

·Works closely with internal/external partners on appropriate process and characterization studies to enable manufacturing

·Assists with product quality attribute assessment and scoring to identify critical quality attributes (CQA)

·Build, hire and develop a team of PhD & non-PhD staff that has the capability to design, plan, and execute experiments to develop and understand processes for production of plasmids

·Proactively develop and sustain strong relationships with current customer accounts and contractual services suppliers to the unit

·Independently review the design, execution, data and reporting on the development work completed within the Process Development group. Is expected to resolve (or have resolved) all technical issues

·Provides key input into the development of manufacturing platforms and novel technologies

·Leads both direct and indirect sub-teams

Qualifications

·PhD in chemical engineering, microbiology, biochemistry, biotechnology, biology, or related field with 6+ years of industry-related experience; or M.S. with 8+ years; or BS with 10+ years of related industry experience

·Ability to lead a cross-functional team to deliver on programs. Previous management experience is required

·Experience in plasmid, mRNA, and/or ASO nucleic acid processes and technologies

·Experience in molecular biology, plasmid design and elements, and manufacturing processes, specifically, transformation, cell banking, production, purification, and storage

·Knowledge and experience in QbD and cGMP is preferred.

·Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects

·Strategic leadership and conceptual thinking to ensure that a cost-effective organization is put in place and developed

·Project-management skills and ability to work successfully with contracting laboratories and manufacturing facilities

·Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

·Demonstrated ability to maintain detailed execution records and perform data analysis

·Expertise in microbial upstream and downstream process development, such as large-scale (50L) fermentation, depth filtration, tangential flow filtration, chromatography column purification

·Experience with microbial production, purification, and characterization

·Strong communication skills (e.g., clear and concise) and a team player

·Strong time and project management skills

·Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution

·Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment

·Takes ownership of the assigned project, consulting with management and peers

·Able to understand and interpret data/information and its practical application

Senior Engineer, Plasmid/Nucleic Acids Manufacturing Sciences and Technology

Summary

Manufacturing Science and Technology (MSAT) is a department within the Nucleic Acid Business Unit at the Center of Breakthrough Medicines. MSAT provides technical support for enabling manufacturing readiness, robustness and GMP compliance of manufacturing processes for plasmids and other nucleic acid based products. The Senior Engineer of MSAT, Nucleic Acids ensures that technical operations such as fermentation, purification, cell banking, media preparation and buffer preparation are optimized, scalable and compliant through strong collaboration and guidance from Process Development, Quality and Manufacturing teams.This role will be responsible for a combination of technology transfer and scaleup, ensuring GMP compliance, facility design/startup support, and day-to-day technical operational support.

Responsibilities

  • Lead a team of engineers, scientists, and/or operators, who perform nucleic acid manufacturing.
  • Ensure a smooth technology transfer from laboratory to pilot plant to full scale GMP manufacturing while ensuring the effective integration of process knowledge into manufacturing operations.
  • Work closely with Manufacturing, Quality, and Process Development teams to ensure that unit operations are thoroughly supported by high quality process documentation (batch records, forms, SOPs, change controls, CAPAs, etc.).
  • Responsible for change control ownership, investigations, and other quality system deliverables.
  • Support day-to-day plasmid manufacturing operations from early clinical phase through and commercial manufacturing.
  • Design and ensure process control strategies, including execution of process risk assessment, justification of process parameters range, and criticality analysis.
  • Support facility standup and facility design to ensure full compliance with GMP standards
  • Accountable for process FMEA original drafting and revision through product life cycle.
  • Leverage MSAT team’s technical knowledge and expertise to lead investigations from initial analysis, root cause determination to establishment and execution of effective CAPAs.
  • Provide on-the floor support during engineering and GMP manufacturing runs. Prevent and resolve issues taking place during production through use of process analytical technologies and product monitoring.

Qualifications

  • Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 4+ years’ experience, MS with 6+ years, BS with 8+ years
  • Proven experience with equipment and manufacturing processes commonly used for fermentation-based bioprocessing.
  • Robust experience in technology transfer from development into a cGMP Manufacturing.
  • Direct experience of working in quality systems, authoring and review of GMP and technical documents.
  • Previous experience in facility commissioning, equipment qualification and maintenance is highly preferred.
  • Thorough understanding of GMP requirements and their relation to process operations.
  • Demonstrated project management capabilities.
  • Self-motivated with strong interpersonal and organizational skills.
  • Emotional intelligence to communicate and interact internally and with clients to drive program deliverables.

June 1, 2022