Job type full-time
Full job description
At roche, 94,000 people across 100 countries are pushing back the frontiers of healthcareWorking together, we’ve become one of the world’s leading research-focused healthcare groupsOur success is built on innovation, curiosity, and diversityWe believe every employee makes a differenceWe are passionate about transforming patients’ livesWe are courageous in both decision and action, we believe that good business means a better world.
The focus of the vacaville operations facility is drug substance bulk manufacturingWe have a passion for science, technology, innovation, professional development, and diversity and inclusionWe are also deeply respected for our unique and special culture; one that centers around the people we attract and hireOur pharma vision is to have a greater overall patient benefit and impactThis focus includes personalized healthcare, designing the processes with the patient in mind, and improving their quality of lifeWe hope you consider joining our team and being a part of one of the largest biotechnology facilities in the world!
The manufacturing sciences purification (ms pur) group is dedicated to providing scientific and technical support to vacaville drug substance manufacturing operations, from harvest through formulation and storageThe ms pur group works in collaboration with manufacturing, process development, quality, and other technical and business functions in order to ensure efficient and safe drug substance manufacturing processes for the production of multiple recombinant proteinsMs pur is responsible for receiving new processes from process development or other manufacturing sites, process monitoring and analysis, process performance troubleshooting, as well as establishment and maintenance of the process validated state and ongoing process improvement.
The open position is for purification engineer/manufacturing technical specialist within the ms pur group, with responsibility for specifying manufacturing process requirements, monitoring and analysis of manufacturing process data, execution of full-scale process validation and technical oversight of scale down (laboratory) experiments, and analyzing process and facility capabilities to identify improvement opportunities.
Specific responsibilities for this position will include (but are not limited to):
Provide purification technical leadership to support commercial drug substance production at genentech vacaville, including specification of process requirements, monitoring, analysis, troubleshooting, and maintenance of the validated state of the manufacturing process.
Provide a science-based approach for resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies.
Authoring and/or review technical documents related to technology transfer, process monitoring, at-scale or scale-down studies, annual product reviews, and non-conformance (deviations/investigations) to support process transfer and ongoing manufacturing.
Contribute to the design, formulation, review, and implementation of purification manufacturing formulae, sops, and associated process documents.
Lead or participate in process validation and technology transfer activities, as well as health authority prior approval inspection for commercial license and product launch.
Participate in the design and technical oversight of laboratory experiments in support of plant operations, troubleshooting, process transfer, process improvement and process understanding.
Participate or lead new technology evaluationContribute to the supporting data necessary for change implementationInteract with planning and manufacturing groups to execute process improvement projects.
Serve as site representative on cross-functional teams including global unit operation teams, technology transfer teams, and global process validation team to define and implement product-focused strategic initiatives at vacaville.
Collaborate with manufacturing, quality, and regulatory organizations to establish a reliable state of manufacturing process control.
Maintain full working knowledge of principles and theories, as well as advancing understanding and state of control in commercial manufacturing process.
Keep abreast of industry best practices, and evaluate potential application within organization, as applicable.
In addition to core responsibilities, the successful candidate may be asked to perform additional technical assignments.
Bs or higher degree in chemical or biochemical engineering.
Minimum of 5 years for b.s (or 2 years for ms or 0 years for phd) work experience in cgmp biopharmaceutical production setting (process development and/or manufacturing technical support)
Experience in large-scale biopharmaceutical manufacturing process, as applied to purification processes (harvest, chromatography, filtration and ultrafiltration diafiltration operations) – including scale-up/scale-down, principles of biochemical engineering, and process data analysis
Full understanding of cgmp requirements
Proficiency in statistical and multivariate data analysis techniques
Self-motivated, able to work independently as well as in teamsExcellent organization and communication skills (both written and verbal)
Demonstrated experience in leading cross-functional teams responsible for the implementation of technical changes / process improvements
Ability to exercise independent judgment and discretion regarding matters of importance and to problem solve in creative waysExcellent written and verbal communication skills
Ability to support international meetings within the roche network (early morning / late evening)
Ability to provide urgent process troubleshooting support for cross-functional teams (off hours as needed)
The ideal candidate will have a general knowledge of the underlying scientific principles applied to the development and manufacture of biopharmaceuticals, and a keen interest in purification bioprocess operationsProficiency in data acquisition and analysis techniques and a willingness to learn new techniques is desiredKnowledge of the following software is desirable: osi pi (and associated client tools), oracle, r, visual basic, sas jmp.
Relocation has been budgeted/approved for this position.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around usGenentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
Genentech requires all new hires to be fully vaccinated against covid-19 as of their start dateThis requirement is a condition of employment at genentech, and it applies regardless of whether the position is located at a genentech campus or is fully remoteIf you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
Job sub category
Apr 14th 2022
Posted 30+ days ago