Jobs
>
San Diego

    Manager to Director Level, CMC API Process Development and Manufacturing - San Diego, United States - Kumquat Biosciences Inc

    Kumquat Biosciences Inc
    Kumquat Biosciences Inc San Diego, United States

    3 weeks ago

    Default job background
    Description

    Job Description

    Job DescriptionDescription:

    Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founders to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having played pivotal roles in the discovery of multiple clinical-stage compounds as well as an approved drug for the treatment of cancers and immune-mediated inflammatory diseases.

    We are currently seeking a highly motivated, creative CMC drug substance professional to join our CMC team in San Diego. This candidate will report to the senior director and head of CMC. This candidate is expected to work closely with Kumquat internal discovery and development teams as well as external CRO/CDMO companies to drive programs into early and late clinical development. This is a position with responsibility for synthetic route design and scouting, process development and manufacturing. The ideal candidate will have an in-depth understanding in all aspects of modern synthetic chemistry, process development, and non-GMP/GMP manufacturing. A strong team player who is detail-oriented and has the desire to learn and understand life-cycle product management concepts and practice is essential. The candidate will have the opportunity to work on multiple programs within the company's pipeline which comprises potentially first-in-class approaches & novel-novel targets.

    Role responsibilities

    • Evaluate available candidate synthetic routes and develop stage appropriate route modification and process optimization strategies.
    • Select external CRO/CDMO partners based on project needs and the external parties' technical capabilities, quality system, and track records.
    • Prepare RFPs and evaluate proposals based on the targeted product quality, project timeline, and budget.
    • Plan and oversee drug substance process optimization, GMP manufacturing, and stability evaluation.
    • Track process development/validation history and manage CMC drug substance related documents in support of life cycle of quality improvement and regulatory filing/updates.
    • Work closely with a cross-functional team within and outside of the CMC department to align with key stakeholders (CMC, clinical, quality assurance and regulatory, etc.).
    • Author and review CMC drug substance related sections for regulatory filing and annual updates.
    • Stay current on industry trends and regulatory requirements to ensure delivery of quality products under non-GMP and GMP environments.
    • Prepare and communicate research results in both oral and written format.
    • Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence.
    Requirements:
    • Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline with at least 5 years of related experience (title for this position will be commensurate with the candidate's experience and qualifications)
    • Strong synthetic organic chemistry knowledge and problem-solving skills.
    • In-depth knowledge of industry practices in drug substance manufacturing and supply.
    • Desire and ability to maintain constructive working relationship with the CMC analytical development team and the CMC drug product team.
    • In-depth knowledge of cGMP regulations and compliance.
    • Track record of accomplishment in managing CMC drug substance projects at early and late development stages.
    • Ability to enable external CRO/CDMO to achieve project goals on time and under budget.
    • Strong written and communication skills, good problem-solving abilities, and an ability to work effectively with a diverse team of co-workers in a dynamic environment.

    Kumquat Biosciences offers an attractive salary and benefits package, including equity incentives.

  • Aurora Technologies

    Sales Representative

    1 week ago

    Aurora Technologies San Diego, United States

    Amoena is the world's leading manufacturer in the field of breast care and developer of the first silicone breast prosthesis. Amoena products in the areas of clinical care, full and partial prostheses, lingerie & swimwear, and lymph care accompany women from diagnosis to returnin ...

  • Meet

    Sr. Manager, Process Development

    2 weeks ago

    Meet San Diego, United States

    We are actively seeking a Manager OR Senior Manager of Process Development & Manufacturing for a growing medical device company in North County San Diego. The team is passionate about innovation and collaboration, with a focus on developing breakthrough class II/III cardiovascula ...

  • StaffWorks, LLC

    Manufacturing Engineer

    1 week ago

    StaffWorks, LLC San Diego, United States

    *This is a temp to hire opportunity* · Outstanding manufacturing company seeks highly skilled Manufacturing Engineer to join phenomenal team. The ideal candidate will be responsible for coordinating with our engineering design team for new product introduction (NPI) from prototyp ...

  • EVONA

    Manufacturing Engineer

    3 weeks ago

    EVONA San Diego, United States

    I'm looking to speak to a skilled Manufacturing Engineer/ Process Engineer who is specializing in electronics manufacturing. · Someone who specifically focuses on the production and assembly of electronic components and devices. · You will need to have a background in industrie ...

  • Belcan

    Manufacturing Supervisor

    3 weeks ago

    Belcan San Diego, United States

    Job Title: Manufacturing Supervisor (Microbiology and Synthesis) · Pay Rate: $51.64 / hr · Location: San Diego, CA · Area Code: 619 · ZIP Code: 92127 · Shift: 1st shift; M-F 7am-3:30pm · Keywords: #ManufacturingSupervisor #Microbiology #Synthesis · Benefits: · Medical / Health Be ...

  • Equal Parts

    Epicor Financial Consultant

    12 hours ago

    Equal Parts San Diego, United States

    Are you ready to take a leadership role within a dynamic team of technology consultants? Cre8tive Technology & Design is seeking a Financial Consultant to drive the implementation of best practice processes using Epicor Kinetic software. Join us in revolutionizing the way manufac ...

  • GTT, LLC

    Process Development Associate

    5 days ago

    GTT, LLC San Diego, United States Contract

    Process Development Associate · Contract Duration 6 Months · Pay rate up to $28.50/hr · Job Summary · Process Development Associate will be responsible for commercial manufacturing and for the creation and transfer of manufacturing processes from R&D to Manufacturing and continuo ...

  • Equal Parts

    Epicor Manufacturing Consultant

    3 weeks ago

    Equal Parts San Diego, United States

    Are you ready to take a leadership role within a dynamic team of technology consultants? Cre8tive Technology & Design is seeking a Manufacturing Operations Consultant to drive the implementation of best practice processes using Epicor Kinetic software. Join us in revolutionizing ...

  • TalentBurst, Inc.

    Manufacturing Supervisor

    1 day ago

    TalentBurst, Inc. San Diego, United States Contract

    Industry: Medical Practice · Position: Manufacturing Supervisor, Synthesis and Production Microbiology · Location: San Diego, CA (On-site) · Duration: 06 months contract (+Possibility of extension) · Manufacturing, Synthesis, and Supervisory experience are HARD REQUIREMENTS (cand ...

  • Domo Modular

    Head of Supply Chain Management

    12 hours ago

    Domo Modular San Diego, United States

    Job Title: Modular Housing Procurement and Supply Chain Manager · Location: San Diego, California, USA · Position Type: Full-Time; In-Office location (not remote) · Company Overview: · Domo Modular is the premier manufacturing and real estate development company in California, ex ...

  • E-talentnetwork

    Manufacturing Engineer 3

    3 weeks ago

    E-talentnetwork San Diego, United States

    Duration: 6+ Months with possibility of CTH · Shift Timing: 7:00 AM - 3:30 PM (Mon-Fri) · Pay Rate:$90k - $140k/annually on W2. · Job Function/Description:The Senior Manufacturing Engineer is responsible for the activities associated with planning, development, implementation and ...

  • Firestorm

    Manufacturing Technician

    1 hour ago

    Firestorm San Diego, United States

    Join us at Firestorm as our Manufacturing Technician. You'll work on and impact all aspects of our manufacturing, post-processing operations, and final assembly of our core products. You'll perform operations such as manual and automated heat staking, precision assembly of electr ...

  • The Mullings Group

    Sr. Director of Product Development

    12 hours ago

    The Mullings Group San Diego, United States

    Sr. Director of Product Development · Medical Device : Biomedical Sensors · Algorithms, Organic Chemistry, Electrode Design · R&D : Product Development : Design For Manufacturing · Multi-Disciplinary Team Management : 50+ Associates · Onsite Mon-Fri San Diego : Direct Placement ...

  • EVONA

    Lead Electrical Engineer

    3 weeks ago

    EVONA San Diego, United States

    Join a Pioneering Space Company Dedicated to High-Reliability Space Subsystems · Responsibilities: · Derive and document circuit board requirements from system and top-level requirements. · Create schematic drawings for complex Printed Circuit Board Assemblies (PCBAs). · Layout a ...

  • EVONA

    Senior Electrical Engineer

    3 weeks ago

    EVONA San Diego, United States

    Join an Exciting Space Company Focused on Advancing High-Reliability Space Subsystems · Responsibilities: · Derive and document circuit board requirements from system and top-level requirements. · Create schematic drawings for complex Printed Circuit Board Assemblies (PCBAs). · L ...

  • Ortho Clinical Diagnostics

    Senior Vision Systems Engineer

    1 week ago

    Ortho Clinical Diagnostics San Diego, United States Full time

    The Opportunity · QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are m ...

  • Cypress HCM

    Sr. Mechanical Engineer

    2 days ago

    Cypress HCM San Diego, United States

    Responsibilities: · Work closely with various engineering disciplines to design, develop, and implement new component designs · Produce leading edge solutions for a diverse range of projects executed in a productive environment · Develop solutions to complex problems using mecha ...

  • South 8 Technologies

    Chemical Engineer

    3 weeks ago

    South 8 Technologies San Diego, United States

    Job Title: Chemical Engineer · Location: San Diego, CA – Bay Park area · Position Type: Full-time · Experience Level: Bachelor's degree in chemistry or related discipline · Benefits: Medical, dental, vision, life insurance, 401k, paid vacation, and a great team · environment · JO ...

  • South 8 Technologies

    Sr. Materials Scientist Engineer

    2 weeks ago

    South 8 Technologies San Diego, United States

    Job Title: Sr. Materials Scientist Engineer · Location: San Diego, CA – Bay Park area · Position Type: Full-time · Experience Level: Masters degree plus at least 5 years relevant industry experience · Benefits: Medical, dental, vision, life insurance, 401k, paid vacation, and a g ...

  • comma

    Hardware Engineer

    1 hour ago

    comma San Diego, United States

    We are seeking an experienced Hardware Engineer to join our team onsite in San Diego. · Key Responsibilities: · Design and construct bespoke test equipment for hardware validation and troubleshooting. · Efficiently operate and optimize a pick-and-place line for PCB assembly. · P ...