Jobs
>
Sacramento

    Sr. Engineer, Process Development - Sacramento, United States - Orca Bio

    Orca Bio
    Orca Bio Sacramento, United States

    3 weeks ago

    Default job background
    Description

    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 %)
    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
  • LiCAP Technologies, INC

    Battery process development engineer

    3 weeks ago

    LiCAP Technologies, INC Sacramento, United States

    Job DescriptionJob Description · More job opportunities can be found at: · Battery process development engineer · Education, Knowledge, Working Experience: · Master/Ph. D Degree, Material Science Engineering, Chemical Engineering, Electrochemical or any other · science/engin ...

  • California Department of Housing and Community Development

    Jc-431647 - Enterprise Business Analyst/tester

    3 weeks ago

    California Department of Housing and Community Development Sacramento, United States

    **Job Summary** · Under direction of the IT Supervisor II, the Information Technology Specialist I (ITS I) provide services which encompass the IT domain of Business Technology Management. The incumbent serves as a business analyst and directs business analysis activities; assist ...

  • Meritage Homes Corporation

    Forward Planning Manager

    3 weeks ago

    Meritage Homes Corporation Sacramento, United States

    **Responsibilities**: · The Forward Planning Manager will assist with the land acquisition feasibility studies, the due diligence land purchase process and with developing entitlement strategies, submissions and presentations. · Assist with obtaining entitlement and permit approv ...

  • PG&E Corporation

    Principal, Quality Operations Specialist

    2 weeks ago

    PG&E Corporation Sacramento, United States

    Requisition ID # 156840 · **Job Category**: Compliance / Risk / Quality Assurance · **Job Level**: Manager/Principal · **Business Unit**: Electric Engineering · **Work Type**: Hybrid · **Job Location**: Sacramento; Oakland · Position Summary · The Quality Operations Specialist is ...

  • City of Sacramento

    Process Control Systems Specialist

    3 weeks ago

    City of Sacramento Sacramento, United States

    **THE POSITION**: · **IDEAL CANDIDATE STATEMENT** · Under general supervision, performs duties involved in the planning, programming, designing, maintaining, and repairing control apparatus, data logging and display equipment, communications systems, Supervisory Control and Data ...

  • Hewlett Packard

    Supplier Operations Manager

    3 weeks ago

    Hewlett Packard Sacramento, United States

    This role is responsible for spearheading the enhancement and maintenance of business systems and processes, leveraging industry-specific expertise and advanced methodologies. The role guides innovative solutions and influences client strategies with a strong grasp of information ...

  • JELD-WEN, Inc.

    Plant Manager

    2 weeks ago

    JELD-WEN, Inc. Sacramento, United States

    **JELD-WEN is currently seeking a **Plant Manager** **to join our growing team.** · As a **Plant Manager**, you will be responsible for managing all plant operations. This position has the overall responsibility for production at their respective manufacturing facility, and for d ...

  • Anvaya Solutions

    Project Manager

    3 weeks ago

    Anvaya Solutions Sacramento, United States

    **Project Manager** · **Mandatory Qualifications** · - Possession of a bachelor's degree. · - Possession of a valid Project Management Professional (PMP) certification from the Project Management Institute (PMI). · - Three (3) years of experience within the last ten (10) years le ...

  • Russell Square Consulting

    Construction Project Manager

    3 weeks ago

    Russell Square Consulting Sacramento, United States

    Russell Square (RS) is a multi-state developer and licensed general contractor with employees currently based in five states in the western half of the United States. We specialize in multifamily development and are responsible for all phases of the real estate development proces ...

  • Public Consulting Group

    IT Project Manager

    3 weeks ago

    Public Consulting Group Sacramento, United States

    Overview: · **About Public Consulting Group** · **Responsibilities**: · The Consultant will provide Project Management services to our internal team as well as expert analysis and risk and recommendation strategies to our clients. The Consultant will work with project team to pro ...

  • United Way California Capital Region

    Director of Program Analytics and Evaluation

    3 weeks ago

    United Way California Capital Region Sacramento, United States

    **Position Description**: · Reporting directly to the Chief Data Evaluation Officer, the Director of Program Analytics and Evaluation holds a critical strategic leadership role at UWCCR. This position is crucial for driving data-driven initiatives that boost the effectiveness of ...

  • Joe's Jeans

    Ft Keyholder

    3 weeks ago

    Joe's Jeans Central Valley, United States

    Specific Responsibilities: · **Sales Generation** · - Consistently motivates the sales team to ensure they are achieving and exceeding individual sales goals and other key performance indicators (KPIs) as determined by the Company. · - Supports the Store Manager in the achievemen ...

  • Department of Social Services

    Staff Services Analyst

    2 weeks ago

    Department of Social Services Sacramento County, CA, United States

    Under the supervision of the Staff Services Manager I (SSM I), the Staff Services Analyst will perform the following duties within Customer Service of the State Hearings Division (SHD): · Analyze, research, and process issues regarding public assistance program hearing requests a ...

  • Sacramento County Office of Education

    Program Analyst

    2 weeks ago

    Sacramento County Office of Education Sacramento, United States

    **We look forward to receiving your information** · **Sacramento County Office of Education Job Description** · **Classification Title: Program Analyst** · DEFINITION · Under general direction, performs a variety of complex financial, technical, and support services involving dat ...

  • California Department of Social Services

    Accountant Trainee

    3 weeks ago

    California Department of Social Services Sacramento, United States

    **The CA. Department of Social Services' Finance and Accounting Division is recruiting for an ACCOUNTANT TRAINEE position in Sacramento County.** · **Job Description and Duties** · The Accounting Disbursements Bureau is recruiting one motivated self-starter seeking a challenging, ...

  • Technology Management Solutions Inc

    Project Manager

    2 weeks ago

    Technology Management Solutions Inc Sacramento, United States

    _We look forward to reviewing your experience, and thank you for taking the time to apply._ · TMS is looking to fill one 1/2 time role for this position. · **Mandatory Qualifications**: · 2. Possession of a bachelor's degree. Additional qualifying experience may be substituted fo ...

  • Michaels Stores, Inc.

    Full Time Customer Experience Manager

    3 weeks ago

    Michaels Stores, Inc. Sacramento, United States Full time

    Store - SAC-GATEWAY, CA · Deliver a customer centric shopping experience by managing and delivering effective front-end operations and expectations. Lead the omnichannel processes. Maintain store recovery standards to deliver our Brand Promises. Deliver friendly customer service. ...

  • Employment Development Department

    Office Assistant

    2 weeks ago

    Employment Development Department Sacramento County, CA, United States

    The Employment Development Department (EDD), Document Management Division is searching for a motivated, skilled, and challenge-seeking individual who enjoys innovation, problem solving, and is interested in working with an exciting team of professionals in a fast-paced environmen ...

  • Public Consulting Group

    Mita (Medicaid IT Architecture) Consultant

    2 weeks ago

    Public Consulting Group Sacramento, United States

    Overview: · **About Public Consulting Group** · **Responsibilities**: · Specific Responsibilities: · - Provide oversight and technical expertise on large-scale IT projects · - Provide technical oversight of applicable vendor and/or client processes, methodologies, and tools to mi ...

  • Employment Development Department

    Tax Administrator I, Employment Development

    3 weeks ago

    Employment Development Department Sacramento County, CA, United States

    **THIS POSITION MAY BE ELIGIBLE FOR A HYBRID WORK SCHEDULE. THE AMOUNT OF TELEWORK IS AT THE DISCRETION OF THE DEPARTMENT AND IS SUBJECT TO CHANGE AS BUSINESS NEEDS ARISE.** · Under the general direction of the Section Chief, the Tax Administrator I plans, organizes, and directs ...