What are the responsibilities and job description for the Senior Manager/Associate Director, Analytical Development position at Cardurion Pharmaceuticals, Inc?

Job Description

Description :

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 CMC, the Senior Manager / Associate Director of Analytical Development will play a critical role in leading and managing small molecule analytical development activities for both drug substance and drug product. The role will be instrumental in establishing and maintaining robust control strategies from early phase programs to commercial readiness.

Here’s What You’ll Do :

Analytical Development and Oversight

Lead analytical method development, validation, and transfer for drug substance and drug product at external analytical laboratories.
Oversee CDMO activities, ensuring deliverables meet timelines, quality standards, and regulatory requirements.
Develop and implement control strategies for small molecule raw materials, intermediates, drug substances, and drug products.
Support impurity profiling, characterization, and qualification.

Stability Studies and Specifications

Design and manage stability studies in compliance with ICH guidelines.

Establish and maintain robust specifications for drug substances, drug products, and excipients.

Evaluate stability data and provide recommendations for retest or shelf-life periods.

Regulatory Documentation and Compliance

Author and review analytical sections of regulatory submissions, including INDs, IMPDs, NDAs, and annual reports.

Ensure all analytical activities comply with GMP / GLP standards and regulatory guidelines.

Maintain rigorous internal documentation, manage change control procedures related to analytical methods, specifications and stability studies.

Cross-Functional Collaboration

Partner with Chemistry and Formulation Process Development, Quality Assurance, Regulatory Affairs, and other departments to support drug development milestones.

Provide analytical expertise during tech transfer and commercialization activities.

Address analytical challenges during troubleshooting or investigations.

Here’s What We’ll Bring to the Table :

Highly competitive benefits package including : Blue Cross Blue Shield PPO, Delta Dental, and VSP vision

Fully funded HSA for high-deductible PPO Plan

401k (traditional and Roth offered) with 100% 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

Flexible Spending Accounts for medical and dependent care expenses

4 weeks Paid Time Off annually

11 company paid holidays and Year-End shut down

Our Mission :

Translate our world-class expertise in cardiovascular signaling pathways into groundbreaking therapeutics for patients.

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 :

PhD in Analytical Chemistry, Pharmaceutical Sciences, or related field with 5 years of experience, or BS / MS with 10 years of experience in analytical development for small molecules within the pharmaceutical industry.

Strong background in small molecule therapeutics, including drug substance and drug product development.

Expertise in chromatographic, spectroscopic, and dissolution techniques (e.g., HPLC, GC, LC-MS, UV-Vis, NMR).

Experience in method development, validation, and transfer in compliance with ICH and FDA guidelines.

Proficiency in designing stability studies and interpreting stability data.

Proven experience managing external partners (e.g., CDMOs / CROs) and cross-functional teams.

Strong problem-solving and decision-making skills with a track record of successful project delivery.

Comprehensive understanding of GMP / GLP requirements, ICH guidelines, and regulatory expectations for analytical development.

Experience authoring and reviewing analytical sections of regulatory submissions.

Exceptional attention to detail and organizational skills.

Strong written and verbal communication skills.

Ability to thrive in a fast-paced, collaborative environment.

Commitment to scientific rigor and quality excellence.

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Senior Manager/Associate Director, Analytical Development

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