Jobs
>
Charlottesville

    Senior Director, CMC Development- API - Charlottesville, United States - Rivus Pharmaceuticals

    Rivus Pharmaceuticals
    Rivus Pharmaceuticals Charlottesville, United States

    2 weeks ago

    Default job background
    Description

    Senior Director, CMC Development- API

    Location: Charlottesville, VA or Bay Area, CA

    Rivus Pharmaceuticals is searching for a Senior Director, CMC Development to set and lead a scalable CMC strategy to advance a new class of investigational medicines called controlled metabolic accelerators (CMAs) that have the potential to improve metabolic health for people with obesity and associated metabolic diseases. This role will report to the COO. This oversight will include all small molecule programs across all stages Pre IND to clinical supply, including HU6 drug substance and drug product manufacturing to commercialization, and manufacturing efforts of other early-stage CMAs.

    Responsibilities:

    · Establish CMC program strategy, including key activities, timelines and budgets

    · Leads CMC team and liaisons with QA and Regulatory groups

    · Ensures alignment within CMC functional areas

    · Responsible for development and implementation of CMC specific SOPs and workflows

    · Identify CMC program risks and develop contingency plans

    · Forge close working relationships across disciplines and with external partners and consultants to advance programs through clinical development

    · Communicates with asset team to ensure CMC deliverables are on-track to support company objectives

    · Supports resource planning, budgeting, and project timeline creation

    · Authors and reviews CMC sections in regulatory submissions and guides CMC regulatory strategy

    · Supports inventory management and global supply chain strategy through development and into commercialization

    · Supports due diligence efforts

    · Manages external process development and manufacturing activities across all phases, including DS/DP validation and commercial launch

    · Drives phase appropriate developmental strategy for DS/DP Guiding and coordinating all in house and external CMC activities.

    · Providing CMC specific scientific expertise and leadership regarding the selection, justification and qualification all vendors subsequent management of all vendor activities, from tech transfer, optimization of API, Formulations, Analytics, DP and supply chain logistics.

    · Reviews batch records for manufacturing or analytical deviations and supports investigations

    · Authors internal reports to maintain knowledge management

    · Supports impurity ID, control strategy, and method development, authors or reviews impurity assessments.

    · Reviews specifications, analytical validation reports, and protocols

    Qualifications

    · BS 15+ years, MS 13+ years. PhD 10+ years of professional in CMC, experience in early-stage pharmaceutical companies.

    · Expertise in API development, including process development, validation and practical pilot plant experience

    · Experience developing scalable supply chain and tools in order to supply FIH to Pivotal multi country Phase 3 studies.

    · Demonstrated expertise in drug product development including familiarization with dissolution and process validation

    · Familiarity with method validation procedures

    · Experienced successfully managing CMOs in the following areas; API, Formulation and Analytics and other vendors to meet program needs

    Interested candidates may forward a CV and Cover letter to

    About Rivus Pharmaceuticals

    Rivus Pharmaceuticals, Inc., a leader in mitochondrial biology, is dedicated to improving

    cardiometabolic health by advancing a new class of medicines called controlled metabolic accelerators (CMAs). Rivus' lead CMA is the investigational small molecule HU6 in development to treat obesity and associated metabolic diseases, including heart failure with preserved ejection fraction (HFpEF), metabolic dysfunction-associated steatotic liver disease (MASLD) / metabolic dysfunction-associated steatohepatitis (MASH) and Type 2 diabetes. For more information, please visit

  • Rivus Pharmaceuticals

    Senior Director, CMC Development- API

    3 weeks ago

    Rivus Pharmaceuticals Charlottesville, United States

    Senior Director, CMC Development- API · Location: Charlottesville, VA or Bay Area, CA · Rivus Pharmaceuticals is searching for a Senior Director, CMC Development to set and lead a scalable CMC strategy to advance a new class of investigational medicines called controlled metaboli ...

  • Eclipse Innovations

    Web developer for frontend and backend development

    3 weeks ago

    Eclipse Innovations Albemarle, United States

    About SelectLine Software GmbH: · We have been an independent specialist for commercial standard software for almost 30 years with headquarters in Magdeburg. · What do we offer? · Flexible working hours and location · Room for your own ideas and their implementation · Possibility ...

  • Gridiron IT Solutions

    Cloud Engineer with Security Clearance

    1 week ago

    Gridiron IT Solutions Charlottesville, United States

    Seeking a Senior Cloud Engineer that is willing to travel to Charlottesville, VA 2-4 per month. TS (SCI eligible) clearance is required. Requirements include: · 10 years of experience implementing DoD or IC information management systems · 5 years of experience supporting enterpr ...

  • Ariel Partners

    DevSecOps Engineer

    4 weeks ago

    Ariel Partners Charlottesville, United States

    We are currently seeking a highly skilled and cleared DevSecOps Engineer to join our dynamic team. The ideal candidate will bring a wealth of experience in designing and implementing information management systems, with a strong background in technical research and product develo ...

  • Base-2 Solutions, LLC

    Software Engineer

    3 weeks ago

    Base-2 Solutions, LLC Charlottesville, VA, United States

    Required Security Clearance: Top Secret/SCI City: Charlottesville State/Territory: Virginia Travel: None Potential for Teleworking: Yes Schedule: Full Time DoD 8570 IAT Requirement: None DoD 8570 IAM Requirement: None DoD 8570 IASAE Requirement: None DoD CSSP Requirement: None La ...

  • Base-2 Solutions, LLC

    Software Engineer

    4 weeks ago

    Base-2 Solutions, LLC Charlottesville, VA, United States

    Required Security Clearance: Top Secret/SCI City: Charlottesville State/Territory: Virginia Travel: None Potential for Teleworking: Yes Schedule: Full Time DoD 8570 IAT Requirement: None DoD 8570 IAM Requirement: None DoD 8570 IASAE Requirement: None DoD CSSP Requirement: None La ...

  • Base-2 Solutions, LLC

    Software Engineer

    3 weeks ago

    Base-2 Solutions, LLC Charlottesville, VA, United States

    Required Security Clearance: Top Secret/SCI City: Charlottesville State/Territory: Virginia Travel: None Potential for Teleworking: Yes Schedule: Full Time DoD 8570 IAT Requirement: None DoD 8570 IAM Requirement: None DoD 8570 IASAE Requirement: None DoD CSSP Requirement: None La ...

  • Base-2 Solutions, LLC

    Software Engineer

    3 weeks ago

    Base-2 Solutions, LLC Charlottesville, VA, United States

    Required Security Clearance: Top Secret/SCI City: Charlottesville State/Territory: Virginia Travel: None Potential for Teleworking: Yes Schedule: Full Time DoD 8570 IAT Requirement: None DoD 8570 IAM Requirement: None DoD 8570 IASAE Requirement: None DoD CSSP Requirement: None La ...

  • Booz Allen Hamilton

    Cloud Platform DevOps Engineer, Lead with Security Clearance

    3 weeks ago

    Booz Allen Hamilton Charlottesville, United States

    Job Number: R Cloud Platform DevOps Engineer, Lead · The Opportunity: As a DevOps engineer, you know how to set up cloud environments and provision computer networking, storage, and virtual networks-ultimately, how to "harness the cloud." We're looking for a seasoned DevOps infra ...

  • Capital One

    Senior Software Engineer, Salesforce

    2 weeks ago

    Capital One Charlottesville, VA, United States Full time

    West Creek , United States of America, Richmond, VirginiaSenior Software Engineer, SalesforceDo you love building and pioneering in the technology space? Do you enjoy solving complex business problems in a fast-paced, collaborative, inclusive, and iterative delivery environment? ...

  • Oran

    Senior Java Developer- NACI Clearance

    3 days ago

    Oran Charlottesville, United States

    We are seeking a talented Java Developer with expertise in Spring Boot, Hibernate, and Struts to join our team within the Department of Defense. The ideal candidate will have a strong background in Java development and possess a National Agency Check with Inquiries (NACI) clearan ...

  • Capital One

    Lead Software Engineer, Salesforce

    2 weeks ago

    Capital One Charlottesville, United States

    West Creek , United States of America, Richmond, VirginiaLead Software Engineer, SalesforceDo you love building and pioneering in the technology space? Do you enjoy solving complex business problems in a fast-paced, collaborative, inclusive, and iterative delivery environment? At ...

  • Base-2 Solutions, LLC

    ICAM Engineer with Security Clearance

    3 weeks ago

    Base-2 Solutions, LLC Charlottesville, VA, United States

    Required Security Clearance: Top Secret/SCI City: Charlottesville State/Territory: Virginia Travel: None Potential for Teleworking: Yes Schedule: Full Time DoD 8570 IAT Requirement: None DoD 8570 IAM Requirement: None DoD 8570 IASAE Requirement: None DoD CSSP Requirement: None La ...

  • Base-2 Solutions, LLC

    ICAM Engineer with Security Clearance

    4 weeks ago

    Base-2 Solutions, LLC Charlottesville, VA, United States

    Required Security Clearance: Top Secret/SCI City: Charlottesville State/Territory: Virginia Travel: None Potential for Teleworking: Yes Schedule: Full Time DoD 8570 IAT Requirement: None DoD 8570 IAM Requirement: None DoD 8570 IASAE Requirement: None DoD CSSP Requirement: None La ...

  • Base-2 Solutions, LLC

    ICAM Engineer with Security Clearance

    3 weeks ago

    Base-2 Solutions, LLC Charlottesville, VA, United States

    Required Security Clearance: Top Secret/SCI City: Charlottesville State/Territory: Virginia Travel: None Potential for Teleworking: Yes Schedule: Full Time DoD 8570 IAT Requirement: None DoD 8570 IAM Requirement: None DoD 8570 IASAE Requirement: None DoD CSSP Requirement: None La ...

  • Base-2 Solutions, LLC

    ICAM Engineer with Security Clearance

    3 weeks ago

    Base-2 Solutions, LLC Charlottesville, VA, United States

    Required Security Clearance: Top Secret/SCI City: Charlottesville State/Territory: Virginia Travel: None Potential for Teleworking: Yes Schedule: Full Time DoD 8570 IAT Requirement: None DoD 8570 IAM Requirement: None DoD 8570 IASAE Requirement: None DoD CSSP Requirement: None La ...

  • Base-2 Solutions, LLC

    Software Engineer

    4 weeks ago

    Base-2 Solutions, LLC Charlottesville, VA, United States

    Required Security Clearance: Top Secret/SCI City: Charlottesville State/Territory: Virginia Travel: None Potential for Teleworking: Yes Schedule: Full Time DoD 8570 IAT Requirement: None DoD 8570 IAM Requirement: None DoD 8570 IASAE Requirement: None DoD CSSP Requirement: None La ...

  • Bytrixtech

    Android Engineer

    3 weeks ago

    Bytrixtech Charlottesville, United States

    We're looking for a talented Android Engineer to join our growing Karachi-based mobile development company. · Job Descriptions & Responsibilities · Design and build applications for the Android platform using Android Studio IDE. · Solid understanding of the full mobile developme ...

  • Sun Tribe

    Product Engineer

    5 days ago

    Sun Tribe Charlottesville, United States

    About Sun Tribe Trading · Sun Tribe Trading is the fastest-growing SREC aggregator, serving the mid-Atlantic. · Solar Renewable Energy Certificates, or SRECs, have proven to be a vital policy tool and financial incentive to make the clean energy transition happen. SRECs simultane ...

  • Base-2 Solutions

    Software Engineer

    2 weeks ago

    Base-2 Solutions Charlottesville, United States Full time

    Required Security Clearance:Top Secret/SCI City:Charlottesville State/Territory:Virginia Travel:None Potential for Teleworking:Yes Schedule:Full Time DoD 8570 IAT Requirement:None DoD 8570 IAM Requirement:None DoD 8570 IASAE Requirement:None DoD CSSP Requirement:None Last Updated ...