Current jobs related to Associate Director/Director, Drug Substance Development - Burlington - Cardurion Pharmaceuticals, Inc
-
Development Director
4 days ago
Burlington, Vermont, United States MENTOR Vermont Full timeAbout MENTOR VermontMENTOR Vermont is a statewide non-profit organization dedicated to strengthening the quality and reach of mentoring relationships in Vermont communities. As an affiliate member of MENTOR: National, we are part of a national network invested in high-quality mentoring relationships and closing the mentoring gap.Job SummaryWe are seeking a...
-
Development Director
3 months ago
Burlington, United States MENTOR Vermont Full timeORGANIZATIONAL BACKGROUND MENTOR Vermont is a statewide non-profit organization that provides funding, resources, and support to the youth mentoring field in Vermont to strengthen the quality and broaden the reach of mentoring relationships in our communities. MENTOR Vermont is an affiliate member of MENTOR: National, a national network of organizations...
-
Packaging Development Director
1 day ago
Burlington, Vermont, United States Jobot Full timeJob Title: Director of Packaging DevelopmentWe are seeking a highly skilled and experienced Director of Packaging Development to lead our packaging development process. This is a unique opportunity to drive innovation and sustainability in packaging solutions.Job SummaryThe Director of Packaging Development will be responsible for creating innovative...
-
Development Director
2 weeks ago
Burlington, Vermont, United States MENTOR Vermont Full timeAbout the RoleMentor Vermont is seeking a highly skilled Development Director to lead our fundraising efforts and external stakeholder communication. As a key member of our team, you will play a critical role in securing the resources needed to support our mission of strengthening the quality and reach of mentoring relationships in Vermont.Key...
-
Director of Packaging Development
7 days ago
Burlington, United States Jobot Full timeJob DescriptionJob DescriptionGreat company culture with strong compensation and comprehensive benefits!This Jobot Job is hosted by: Brendan ThomasAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $150,000 - $190,000 per yearA bit about us:We are an award-winning food manufacturer!We're growing fast and...
-
Director, Business Development
2 weeks ago
Burlington, United States Esri Full timeSekisui Diagnostics, a leader in invitro diagnostics, is seeking an experienced Director of Corporate Development/Business Development to lead business development activities to achieve our short- and long-term strategic goals and objectives.In this role, you will showcase your expertise in all aspects of Business Development and partnering by identifying...
-
Director, Business Development
3 days ago
Burlington, United States Esri Full timeSekisui Diagnostics, a leader in invitro diagnostics, is seeking an experienced Director of Corporate Development/Business Development to lead business development activities to achieve our short- and long-term strategic goals and objectives.In this role, you will showcase your expertise in all aspects of Business Development and partnering by identifying...
-
Associate Director
4 days ago
Burlington, Vermont, United States Guidehouse Full timeJob Title: Associate Director - Energy TransitionGuidehouse is seeking an experienced Associate Director to join our Energy, Sustainability, and Infrastructure segment. As a key member of our North Market Team, you will be responsible for developing project results and client management on large engagements.Key Responsibilities:Manage teams responsible for...
-
Packaging Development and Engineering Director
3 weeks ago
Burlington, Massachusetts, United States Complete Staffing Full timeJob DescriptionJob Title: Director of Package Development and InnovationCompany: Complete StaffingLocation: Boston, MAJob Type: Full-timeIndustry: Consumer GoodsJob Description:Job SummaryWe are seeking a highly experienced and skilled Director of Package Development and Innovation to lead our packaging team and drive innovation in packaging design and...
-
Director of Nursing
5 days ago
Burlington, Vermont, United States HealthEcareers - Client Full timeDirector of Nursing OpportunityAt HealthEcareers - Client, we are seeking an experienced Director of Nursing to lead our nursing team in providing high-quality patient care.Key Responsibilities:Supervise and coordinate all nursing services to ensure compliance with regulatory policies and procedures.Represent the facility in a professional manner to...
-
Maintenance Director
2 weeks ago
Burlington, Washington, United States Frontier Management Group Full timeMaintenance DirectorFrontier Senior Living is seeking a skilled Maintenance Director to oversee the upkeep of our community in Burlington, Washington.Key Responsibilities:Perform a wide range of building maintenance and mechanical work, including carpentry, electrical, plumbing, and painting.Respond promptly to resident apartment maintenance or...
-
Director of Package Development
1 month ago
Burlington, United States Complete Staffing Full timeDirector of Package Development Director of Package Development – $175K + bonus, Boston hybrid The role is responsible for leading the Package Development & Engineering team and overseeing the planning, execution, and management of the development and engineering of all packaging. The individual in this role will play a crucial role in shaping our...
-
Executive Director, Medical Writing
4 months ago
Burlington, United States MapLight Therapeutics, Inc. Full timeWho We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll...
-
Executive Director, Medical Writing
3 weeks ago
burlington, United States MapLight Therapeutics, Inc. Full timeWho We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll...
-
Executive Director, Medical Writing
3 weeks ago
burlington, United States MapLight Therapeutics, Inc. Full timeWho We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll...
-
Executive Director, Medical Writing
4 months ago
Burlington, United States MapLight Therapeutics, Inc. Full timeWho We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll...
-
Wine Director
2 weeks ago
Burlington, Massachusetts, United States ASAP Associates Full timeWine Director OpportunityWe are seeking an experienced Wine Director to join our team at ASAP Associates. Our fine dining restaurant in Burlington, MA offers a unique and upscale dining experience, with a wine list featuring over 400 vintages.Key Responsibilities:Maintain and improve the quality of our wine listEngage with customers and elevate their dining...
-
Director of Nursing
4 days ago
Burlington, Vermont, United States HealthEcareers - Client Full timeDirector of Nursing OpportunityAt HealthEcareers - Client, we are seeking an experienced Director of Nursing to lead our nursing team in providing high-quality patient care.Key Responsibilities:Oversee the provision of quality patient care through the supervision and coordination of all nursing services.Monitor adherence to regulatory policies and...
-
Executive Director of Medical Writing
5 days ago
Burlington, Vermont, United States MapLight Therapeutics, Inc. Full timeJob Title: Executive Director of Medical WritingMapLight Therapeutics, Inc. is seeking an experienced Executive Director of Medical Writing to join our team. As a key member of our Regulatory Affairs department, you will be responsible for establishing and overseeing our medical writing function, ensuring the accuracy and quality of submission-ready...
-
Wine Director
3 hours ago
Burlington, Massachusetts, United States ASAP Associates Full timeWine Director/Sommelier OpportunityWe are seeking an experienced Wine Director/Sommelier to join our team at ASAP Associates. Our fine dining restaurant in Burlington, MA offers a unique and upscale dining experience, with a wine list featuring over 400 vintages.Key Responsibilities:Maintain and improve the quality of our wine listEngage with customers and...
Associate Director/Director, Drug Substance Development
4 months ago
Why join Cardurion Pharma?
At Cardurion, we are advancing the understanding of the cellular mechanisms that regulate heart function and are developing new treatments to address cardiovascular disease. Our programs seek to modulate signaling pathways that regulate heart cell function to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our site to learn more about our Company and how we are advancing the promise of cardiovascular signaling pathways science to improve health and impact lives around the world.
The Role:
Reporting to the Vice President of Manufacturing and CMC, the Associate Director/Director of Drug Substance Development will be responsible for all aspects of drug substance development across multiple Cardurion programs. The Associate Director/Director is recognized as the drug substance subject matter expert and expected to effectively communicate with all levels of the organization and vendors. The incumbent demonstrates strong leadership and capabilities to bring important medicines to patients in alignment with the company’s overall mission. It is a highly independent position that requires a motivated and effective team player who can thrive in a fast-paced environment, balance multiple priorities and operational constraints effectively to cross-functional colleagues.
Here’s What You’ll Do:
· Responsible for managing all aspects of small molecule drug substance development and manufacturing at CDMO’s.
· Responsible for sourcing of starting materials for drug substance manufacturing and ensuring their timely delivery and quality.
· Responsible for planning stage appropriate development activities and working with the CRO/CDMO’s on their timely execution.
· Develop integrated risk mitigation strategies for critical path issues/program risks to ensure timely delivery of program milestones.
· Designs process optimization activities to ensure API processes are robust, cost-effective and fit for purpose.
· Responsible for technical review of the batch records as well as working with Quality Assurance personnel to ensure that manufacturing activities are conducted in compliance with cGMP’s and applicable regulatory requirements.
· Contribute to building and maintaining Quality infrastructure in support of external CMC operations.
· Responsible for authorship of drug substance IND/IMPD/NDA sections.
· Responsible for management of drug substance related documentation, batch records, development reports and stability reports in accordance with internal SOP’s.
· Coordinate periodic meetings with CRO’s/CDMO’s to monitor progress of ongoing work, and provide technical feedback, review reports and meeting minutes.
Here’s What We’ll Bring to the Table:
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), Delta Dental, and vision offered through VSP
- Fully funded HSA for high-deductible PPO Plan
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 4 weeks Paid Time Off annually
- 401k (traditional and Roth offered) with 50% match on first 4% deferred. Match is vested immediately
- A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability
- 10 company paid holidays and Year-End shut down
Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Requirements:Here’s What You’ll Bring to the Table:
· Ph.D. in Organic Chemistry with 8+ years of small molecule process chemistry experience in biotech, pharma or CDMO industries.
· Technical depth and a broad understanding of chemical process and analytical development.
· Familiarity with cGMP and ICH guidelines for drug substance for late-stage clinical trials.
· Experience with managing CDMO’s.
· Experience with process development for small molecule drug substance, scale up, and process transfer between CRO’s/CDMO’s.
· Experience with analytical method development and validation for drug substance and starting materials
· Proficient in technical report writing.
· Outstanding communication skills (verbal and written).
· Ability to manage multiple projects in a fast-paced environment.
· Ability to effectively collaborate effectively in a dynamic, cross-functional environment.