Associate Director, Analytical CMC – Small Molecules
Rivus Pharmaceuticals, Inc.
Associate Director, Analytical CMC – Small Molecules
Location: Charlottesville, Virginia
Rivus Pharmaceuticals is looking for an Associate Director of Analytical Chemistry with Quality Control (QA)expertise to support the analytical development of methods to advance Rivus’ small molecule pipeline of Controlled Metabolic Activators (CMA) programs. The successful candidate will be involved in Chemistry, Manufacturing and Control (CMC) activities from preclinical to Phase 3 clinical development. This person will interface with a variety of CRO and CDMO activities not limited to monitoring and guiding analytical methods development and phase appropriate validations, QC oversight, managing outsourcing activities of both drug substance and drug product, contributing to the review and authoring the analytical sections of INDs, IMPDs, and NDAs. Experience in analytical development of small molecule API in fast paced environments and in (early) phase development is considered an asset. Quality control experience is a requirement. The candidate should also have excellent skills for working in a collaborative and cross-functional, dynamic environment.
Key Responsibilities
Responsibilities
- Overseeing drug substance and drug product analytical activities from preclinical phase through clinical development and beyond.
- Review analytical methods, validation reports, release analytics, stability studies and offer guidance to vendors including troubleshooting.
- Experience managing multiple stability studies for both Drug Substance and Drug Product.
- Apply and define phase appropriate analytical strategies according to ICH guidelines for both drug substance and drug product and reviewing/authoring corresponding quality sections for regulatory submissions.
- Support the development and implementation of manufacturing strategies for drug substance and drug product.
- Management of timelines, resources and budgets.
- Act as analytical lead, representing the CMC team within project teams by participating in project meetings and giving regular updates.
- Partner with project teams to seamlessly advance our small molecule development candidates into clinical development.
- Identify, select and manage appropriate Contract Development & Manufacturing Organizations (CDMOs) for appropriate analytical development to support of drug substance and drug product manufacturing under cGMP .
Experience and Qualifications
Qualifications
- PhD, MSc or BS in Analytical Chemistry with 15 years of industry experience in the pharmaceutical or biotech industry in small molecule analytical method development.
- Experience with analytical techniques to support both drug substance and drug product.
- Experience in analytical development for projects in clinical development (Phase 1 through Phase 3).
- Thorough knowledge of ICH guidelines and most relevant FDA and EMEA regulations.
- Work closely with CROs/ CDMOs to execute Analytical Development and Analytical Quality Control activities according to program needs.
- Excellent interpersonal, communication and teamwork skills.
- Flexibility, problem solving, ability to work in a dynamic environment.
- Sound understanding of CMC regulatory requirements for small molecule DS/DP and direct experience with compiling the analytical CMC sections of INDs, IMPDs and NDAs
- Experience in supply chain management is considered a plus.
Interested candidates may forward a CV and Cover letter to Careers@rivuspharma.com
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 www.rivuspharma.com.
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