Sr. Engineer, Process Development

4 weeks ago

Sacramento, United States Orca Bio Full time
Summary:

The Sr. Engineer/Scientist in Process Development, CMC will focus on commercialization and post-commercial process optimization of allogeneic cell therapy manufacturing processes. You will contribute to technology transfer into GMP manufacturing, evaluation of replacement and novel raw materials, BLA content generation, scale-up/scale-out, and process/operational optimization to advance Orca's clinical pipeline into commercialization. This role is expected to closely collaborate with multiple teams across Process Development, MSAT, Analytical Development, Regulatory Affairs, Quality and Manufacturing.

Responsibilities:

•Play a lead role for core activities during technology transfer of processes into GMP clinical and commercial manufacturing, including on-floor support as Person-In-Plant and authoring and reviewing of technical documents

•Author and review plans, protocols, technical reports and CMC sections of regulatory submissions

•Review and support continuous improvements of manufacturing procedures for pre-commercial and post-commercial lifecycle management of the manufacturing process

•Lead projects to optimize and implement process improvements related to closed and single-use cell therapy manufacture

•Coordinate implementation of process improvements and new process technology into clinical and commercial GMP facilities

•Collaborate with external vendors and internal engineering teams to design and implement novel automation and closed processing technologies for cell therapy production

•Contribute to process characterization and process validation work packages to progress the CMC development of Orca's clinical pipeline

•Participate in investigations and troubleshooting of both manufacturing issues and lab studies

Qualifications:

•PhD, MSc in Chemical Engineering, Biotechnology, or related field; candidates with Master's or Bachelor's degree will be considered with additional experience

•3-7 years of experience (depending on education) in process sciences or manufacturing

•Experience with commercial biologic (e.g., antibody, recombinant protein) processes; cell/gene therapy experience preferred

•Experience with aseptic techniques and closed manufacturing systems

•Experience with late-stage process development, including process characterization and/or process validation preferred

•Experience with regulatory (e.g., IND, BLA) authoring

•Experience with quality risk management (i.e., risk assessments)

•Ability to travel to Sacramento occasionally (10 - 20%)

Additional Attributes:

•Demonstrated organizational, record-keeping, and problem-solving skills, with an attention to detail

•Strong interpersonal skills including verbal and written communication

•Demonstrated success working independently as well as in a team environment

•Ability to act with urgency and agility to bring lifesaving therapies to patients

•Intense curiosity and a propensity to break with the status quo

  • Sr R&D Process Engineer

    4 days ago

    Sacramento, California, United States General Mills, Inc Full time

    Job Description JOB OVERVIEW As the Pet segment continues to grow, we are looking for a Sr. R&D Engineer to join our Pet R&D Process team to help enable us to deliver on the short- and long-term plans in this critical category for General Mills. In this Sr. R&D Engineer role, you will develop expertise across Pet processing technologies to commercialize...

  • Sr R&D Process Engineer

    22 hours ago

    Sacramento, California, United States General Mills, Inc Full time

    Job Description JOB OVERVIEW As the Pet segment continues to grow, we are looking for a Sr. R&D Engineer to join our Pet R&D Process team to help enable us to deliver on the short- and long-term plans in this critical category for General Mills. In this Sr. R&D Engineer role, you will develop expertise across Pet processing technologies to commercialize...

  • Sr. Systems Engineer

    3 weeks ago

    Sacramento, United States UrBench Full time

    Job DescriptionJob DescriptionHi, here is a role that requires onsite in Sacramento (Rocklin), CA. 12+ month contract. Candidates from anywhere are OK, as long as they can relocate to Sacramento for the duration of the project. PST candidates 1 choiceUSC/GC/GC-EAD/H4-EAD$60/hrSr. Systems Engineer Skills - Must have: Linux, Active Directory, Azure Cloud,...

  • Process Engineer

    1 month ago

    West Sacramento, United States CareerBuilder Full time

    **Process engineer / SENIOR Process engineer, Pilot Scale Development** West Sacramento, CA - Full Time **OVERVIEW** We are seeking a motivated chemical engineer to join our rapidly growing company. This position will report to the VP of Chemistry and will be responsible for leading a team of engineers in the scaling of our novel chemistry from the bench to...

  • Process Engineer

    3 weeks ago

    Sacramento, United States Plasma International Ltd Full time

    About the job Process Engineer Our Client is committed to pushing the boundaries of energy storage solutions and their mission is to accelerate the transition to a sustainable and electrified future. As an exciting growing company in the industry, they are dedicated to fostering an environment that encourages creativity, collaboration, and cutting-edge...

  • Sr Firmware Engineer

    1 week ago

    Sacramento, California, United States Resideo Full time

    Job DescriptionAs a Sr. Firmware Engineer, you will develop embedded solutions for Resideo's HVAC appliance controls including appliance control, graphical user interfaces (GUI's), and IoT solutions. You will create project and technical reports as required and help define product architecture as needed. You will participate in schematic/layout review...

  • Sr Firmware Engineer

    24 hours ago

    Sacramento, California, United States Resideo Full time

    Job DescriptionAs a Sr. Firmware Engineer, you will develop embedded solutions for Resideo's HVAC appliance controls including appliance control, graphical user interfaces (GUI's), and IoT solutions. You will create project and technical reports as required and help define product architecture as needed. You will participate in schematic/layout review...

  • Sr. Controls Engineer

    2 weeks ago

    Sacramento, United States Oxford Global Resources Full time

    Title: Sr. Controls Engineer (with Schneider PLC) Location: Sacramento, CA If not local - 60% remote 40% travel to Sacramento, CA.Length of Contract: 6-7 months (EOY)Hours Estimate: 40 hours per weekIdeal Start date: 5/27 or soonerDrug screen and Background check is required. Client is looking for an senior controls engineer who can oversee the full project...

  • Sr Software Engineer

    1 week ago

    Sacramento, California, United States Cox Enterprises Full time

    The Sr Software Engineer writes and maintains code within applications and systems to implement capabilities and features, improve performance and maintainability, while reducing technical debt in alignment with product and technology roadmaps. The Software Engineer plays a role in Agile planning, providing advice and guidance, and monitoring emerging...

  • Sr Software Engineer

    20 hours ago

    Sacramento, California, United States Cox Enterprises Full time

    The Sr Software Engineer writes and maintains code within applications and systems to implement capabilities and features, improve performance and maintainability, while reducing technical debt in alignment with product and technology roadmaps. The Software Engineer plays a role in Agile planning, providing advice and guidance, and monitoring emerging...

  • Sr Project Manager, Healthcare

    1 week ago

    Sacramento, United States XL Construction Full time

    Description Position at XL Construction Sr. Project Manager, Healthcare, Business Acquisition and PreCon experience. This person will have direct responsibility for all aspects of a single large, complex project or for multiple small/mid-size projects. They lead all phases of a project through its life cycle, including estimating, purchasing, engineering,...

  • Sr. Quality Engineer

    1 week ago

    Sacramento, California, United States Inspire Medical Systems, Inc. Full time

    ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our...

  • Sr. Quality Engineer

    1 day ago

    Sacramento, California, United States Inspire Medical Systems, Inc. Full time

    ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our...

  • Sr. Mechanical Engineer

    3 days ago

    Sacramento, United States Incendia Partners Full time

    Compensation & Benefits: The base salary is up to $130,000.00 (capped, cant exceed), with performance bonuses when there is profit, a 401(k) match of 3%, and 100% healthcare coverage for employees and families. Additional benefits include, Dental Insurance, Life Insurance, Paid Vacation, Paid Holidays and Paid Sick Leave. Travel to Northern California job...

  • Sr. Mechanical Engineer

    1 week ago

    Sacramento, United States Incendia Partners Full time

    Job DescriptionJob DescriptionCompensation & Benefits: The base salary is up to $130,000.00 (capped, cant exceed), with performance bonuses when there is profit, a 401(k) match of 3%, and 100% healthcare coverage for employees and families. Additional benefits include, Dental Insurance, Life Insurance, Paid Vacation, Paid Holidays and Paid Sick Leave.Travel...

  • Sr. Mechanical Engineer

    1 week ago

    Sacramento, United States Incendia Partners Full time

    Job Description Job Description Compensation & Benefits: The base salary is up to $130,000.00 (capped, cant exceed), with performance bonuses when there is profit, a 401(k) match of 3%, and 100% healthcare coverage for employees and families. Additional benefits include, Dental Insurance, Life Insurance, Paid Vacation, Paid Holidays and Paid Sick Leave....

  • RF & Microwave Power Amplifier Design Engineer

    1 month ago

    Sacramento, United States CareerBuilder Full time

    Sr. RF & Microwave Power Amplifier Design Engineer Sacramento County, California The Sr . RF & Microwave Power Amplifier Design Engineer would be responsible for: Design of RF & Microwave assemblies, analog circuits, power supplies and other components used in high-power, solid-state amplifiers and amplifier systems. Design power amplifier matching networks...

  • Sr. Systems Engineer

    1 week ago

    Sacramento, California, United States Inspire Medical Systems, Inc. Full time

    ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our...

  • Sr. Systems Engineer

    18 hours ago

    Sacramento, California, United States Inspire Medical Systems, Inc. Full time

    ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our...

  • Sr. Software Engineer

    1 week ago

    Sacramento, California, United States Inspire Medical Systems Full time

    ABOUT INSPIRE MEDICAL SYSTEMSInspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus...