The Manufacturing Science and Technology (MS&T) Scientist/Engineer will be primarily responsible for support of technology transfer & development activities for both upstream and downstream aspects of the process. This role will be expected to independently execute tasks in the following areas for both drug substance (DS) and drug product (DP) specific activities to include:
- Translation of process requirements from source documents into tech transfer (sending) requirements into protocols and batch records (receiving)
- Identification and technical review of alternative materials and consumables relative to process requirements.
- Review of executed GLP & GMP manufacturing records
- Participate in daily tech transfer meetings as scribe, SME and action owner.
- Process scale up, support and trouble shooting
- investigation support to close deviations (non-conformance)
In this role the Sr. Scientist/Engineer may be responsible for authoring and reviewing relevant sections of regulatory dossiers as well as answering questions stemming from these regulatory filings. Scope of responsibilities include but are not limited to: deviation support, process control strategy development, validation supporting studies as well as process robustness.
- During the manufacturing preparation phase, this role will lead delivery of pre-run deliverables such as Materials List, Process Transfer Documents, NORs and Targets for process control parameters in the Manufacturing Batch Records, Process Monitoring plans, etc. To meet these deliverables the MS&T lab will both generate data and compile data from external sources, e.g. CDMOs, CMOs.
% of Time
Job Function and Description
- During the manufacturing execution phase, lead selected manufacturing investigations related to product impact, change control justifications, and implementation related to process and equipment adequacy and efficiency, process monitoring, and general troubleshooting.
- During the Campaign Close-out phase, complete investigations, auxiliary studies and data analysis to ensure timely product disposition. In addition, contribute to playbooks in anticipation of regular Agency and Partner interactions.
- Throughout all phases, this position will execute Root Cause Analysis, as well as drive continuous improvement and process improvement opportunities.
Core Team member of Technology Transfer & Process Teams in the role of Technical subject matter expert (SME). This role may require up to 45% business travel.
- Write, Review deviations pertaining to manufacturing processes and perform product impact assessments for facility, and raw material deviations.
- Design process characterization protocols as needed, and oversee that Process Monitoring regulatory requirements are being met.
- Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments in preparation for GMP Manufacturing
- Approvals of any Manufacturing Change Controls, Validation protocols, and CAPAs, collaborate with Manufacturing on CAPA effectiveness.
- As needed, be present at CMOs & CDMOs to monitor execution of production and studies, as well provide technical guidance as needed.
Manage individual performance to achieve business goals and objectives, as well ongoing professional development.
Education and Experience Requirements
- Manage performance: know what is expected, what it takes to be successful, and self-monitor progress. Be accountable to achieve results while demonstrating the Spark Values. Periodically review individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
- Commit to collaborate. Be a strong team player and business partner cross functionally. Understand the development goals, strengths and motivators of your colleagues and partner to achieve mutual success and continuous improvement as well as professional development.
- Foster Spark’s Culture, Mission, Vision, and Values: Lead by example. Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
- BS in Life Science/Engineering or related field required.
- Minimum 2 years of experience in the Biotechnology or Pharmaceutical industry.
- Experience in biopharmaceutical based GMP manufacturing science and technology.
- Direct experience in cell culture and/or purification (downstream) in development and/or production environments.
Key Skills, Abilities, and Competencies
- Proven track record of contributions to manufacturing technology platform development, in a GLP/GMP Pilot Plant and/or development lab facility.
- Demonstrated technical project management experience to develop project goals, deliverables, timelines, budget management and ongoing prioritization.
- Experience with accelerated CMC development pathways a plus
- Knowledge of GXP compliance
Complexity and Problem Solving
- The position requires knowledge and experience with cGMP upstream manufacturing of biopharmaceuticals or biologics and the life cycle management of these processes. Experience with virus or vaccine manufacturing a plus.
- Demonstrated ability to lead investigations, study execution, and produce high quality technical documentation.
- Proven ability to productively collaborate cross functionally to deliver results. Acts to promote a productive and cooperative climate. Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others. Encourages or facilitates a beneficial resolution of purpose. Resolve conflicts in a constructive manner that allows win/win solution
- Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
- Experience with data analytic tools such as SAS JMP a plus.
Internal and External Contacts
- Efficiently complete true root cause analysis, corrective action plan development and execution, including effectiveness verification.
- Ability to prepare contingency plans and logically work through complex technical issues in a pressure filled atmosphere
- Ensure resolution to all organizational, technical and product lifecycle management issues.
- Erroneous decisions or failure to achieve results may have significant financial implications or cause delays in schedules.
- Regular cross functional interactions internally with Process Development, Analytical Sciences, QA, QC, RA CM, PMO Functions.
- Regular cross functional interactions with external CDMP and CMO organizations
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.