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

Rivus Pharmaceuticals Charlottesville, United States

4 weeks ago

Pharmaceutical / Bio-tech

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

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