What Youll Do
Provides oversight on all aspects of site readiness technology transfer (TT) programs and ongoing manufacturing activities related to process analytics (PA) deliverables
Establishes and ensures timelines and plans align with relevant stakeholders and that deliverables are successfully completed on time
Ensures team project plans are integrated with other scheduling functions within the organization and in alignment with program scope
Escalates risks and tracks milestone progress while ensuring cross functional communication to key stakeholders
Provides oversight on the execution and advancement of process trends and process verification plans
Serves as the point of contact to customer and internal regulatory team for technical aspects of the process and program
Facilitates delivery of documentation for internal and external use such as comprehensive written manufacturing protocols and reports summarizing investigations studies and projects
Serves as the subject matter expert (SME) while leading and conducting troubleshooting process impact assessments and executing root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
Manages Chemistry Manufacturing and Control (CMC) activities for development and manufacturing including coordination and input to customer regulatory filings
Identifies training needs and facilitates training for laboratory and manufacturing teams
Oversees the development and roll-out of training content related to PA tools
Supports role in Good Manufacturing Practices (GMP) environment
Leads the technical team with investigating project challenges through risk assessment tools and techniques as needed
Closes deviations and provides a thorough explanation of findings to internal and external stakeholders
Utilizes new knowledge to promptly drive data-based decisions
Ensures master batch records (MBRs) and sample plans support PA requirements
Negotiates with cross-functional stakeholders
Oversees data stewardship and data governance activities including alignment with global FDB network
Ensures data and analyses are findable accessible interoperable and reusable to internal and external stakeholders
Leads best practices for TT and process performance qualification (PPQ) strategies globally as required
Oversees informatics and data systems improvement initiatives to improve scalability manufacturability reliability yield and cost
Serves as a key contributor to the PA strategic roadmap development and owns delivery of assigned items
Communicates and aligns roadmap elements with internal and external stakeholders as directed
Oversees the evaluation of new analytical technologies (e.g. Process Analytical Technologies (PAT) Data Science tools) and the development of new solutions
Provides guidance on implementation and sustainment strategies
Oversees stewardship of critical knowledge for PA tools PAT and supporting systems
Writes reviews and provides SME feedback for standard operating procedures (SOPs) work instructions white papers and other relevant documentation
Routinely represents FDB at technical conferences seminars etc. and engages the biotechnology community
Remains up to date on best practices and industry trends and ensures PA team is aware
Develops presentations publications scientific articles and other materials for external engagement with the external scientific community
Facilitates the design of study and/or sampling protocols by ensuring the PA and Manufacturing teams provide input and review
Mentors junior team members lab and manufacturing colleagues
Other duties as assigned
Knowledge and Skills
Ability to adapt communication style to differing audiences and advise others on difficult matters
Advanced problem-solving and project management skills
Ability to effectively present complex information to others
Ability to develop effective working relationships internally and externally
Proficient with Snowflake and Python
Proficient with structured query language (SQL) writing skills
Strong knowledge of process historians and data management systems (e.g. OSI PI Statistica SIMCA)
Proficient knowledge in Statistical Process Control (SPC) and multivariate data analysis
Strong knowledge of machine learning techniques data science and PAT
Proficient knowledge of regulatory requirements related to data integrity and PAT
Intermediate knowledge of business acumen negotiation tactics and ability to build business cases
Proficient ability to integrate and facilitate activities across multiple teams
Ability to remain up to date on best practices and industry trends
Basic Requirements
Bachelors degree in Data Science Biotechnology or Chemical Engineering with 12 years of relevant experience (e.g. data engineering manufacturing bioprocess development PAT); or
Masters degree with 8 years of relevant experience (e.g. data engineering manufacturing bioprocess development PAT); or
PhD with 5 years of relevant experience (e.g. data engineering manufacturing bioprocess development PAT)
Experience working in a GMP environment
Experience using Quality Systems (e.g. Deviation Management system Change Control CAPA document management system)
Experience using Risk Management and RCA tools
Experience with multivariate modeling and/or PAT application
Prior experience leading new technology or method implementations and sustainment projects
Preferred Requirements
Prior biologics drug substance and manufacturing experience including process development validation and transfer
Experience authoring CMC sections for regulatory filings and supporting regulatory audits
Experience transferring and scaling new technologies and/or methods across a manufacturing network
Experience working with a wide range of data analytics architectures (e.g. warehousing distributed computing visualization analytics)
Experience leading and influencing cross-functional teams
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. X No Yes
Ability to ascend or descend ladders scaffolding ramps etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes
Ability to sit for prolonged periods of time. X No Yes
Ability to conduct activities using repetitive motions that include writs hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes 10 lbs. 33 lbs.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. X No Yes