Vice President of Chemical Development and Pharmaceutical Sciences

About Nirogy

Our vision is to create a “curative path to end patients’ sufferings afflicted by many diseases” with a mission to discover and develop innovative medicines for hard-to-treat chronic diseases. Nirogy Therapeutics is a well-funded biotech based in Natick, MA, developing small molecule therapeutics with special focus on cancer metabolism and immuno-oncology, autoimmunity, and inflammation therapeutic areas.

The Role

Nirogy Therapeutics is seeking a highly motivated and experienced leader for Vice President of Chemical Development and Pharmaceutical Sciences. This position is responsible for the chemical process development, manufacture and supply of all small molecule drug substances from the research stage through clinical development, marketing approval, commercial production, and drug product development. We are seeking an exceptional candidate, an indispensable role that will advance our lead programs on cancer metabolism and immuno-oncology, autoimmunity, and inflammation.

The Responsibilities

  • Manage the process chemistry for rapid and innovative development and scale up of target compounds in R&D pipeline.
  • Identify, select and manage Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of API and DP in support of ongoing non-clinical and clinical programs
  • Identify, select and manage Contract Research Organizations (CROs) for process optimization, cGMP manufacture and supply of API and DP in support of non-clinical and clinical programs
  • Deliver robust, scalable and cost-effective manufacturing routes for API manufacturing
  • Apply GMP manufacturing strategies of drug substances for development programs and commercial products
  • Implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
  • Responsible for technology transfer, chemical outsourcing, and external manufacturing to deliver a robust supply chain for all drug substances incorporating quality, safety, compliance, cost effectiveness, sustainability and reliability to meet global demands
  • Design and implement drug substance regulatory strategy to ensure product quality, facilitate regulatory approvals globally and achieve operationally flexible supply chain
  • Writing and reviewing documents for INDs / regulatory section submissions
  • Design and develop formulations that meet target product profile for the clinic
  • Advocate a quality culture, maintaining safety and achieving high performance
  • Operational focus, fiscal accountability and long-term strategy in sync with R&D pipeline, commercial portfolio and company strategy.

The Qualifications

  • Ph.D. with 15+ years of relevant experience
  • Sound knowledge of organic chemistry, process engineering and plant operations
  • Proven track record of establishing and delivering a robust supply chain for diverse drug substance portfolios to meet global product demand
  • Experience with small molecule drug substance manufacturing networks
  • Well versed in drug substance manufacturing control strategies
  • Well versed in FDA and ICH guidelines relating to registration, quality and compliance concerning small molecule drug substance.
  • Strong business acumen including business contracting expertise
  • Experience with CMC requirements for drug development of new molecular entities
  • Proven ability to lead high performing teams

A Competitive Package

At Nirogy, we are pioneering innovative and untapped scientific technologies to make patients’ lives better. We endeavor to provide a highly competitive benefit package that includes:

  • Competitive compensation based on experience, including participating stock options
  • Employees at Nirogy will be eligible to earn a performance-based bonus
  • We offer a great competitive Total Rewards package which includes 401(k), health, dental, and vision as well as other great competitive benefits

How to Apply:

Please fill out the job form below, provide a CV/resume, and select the position of interest.

Nirogy Therapeutics, Inc. is firmly committed to providing Equal Opportunity Employment.

Job Form

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Vincent P. Sandanayaka, Ph.D.

FOUNDER

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