Process Development Manager - CMC

Elysium is seeking a Process Development Manager that will be responsible for CMC activities relating to pharmaceutical development.  In this position, you will be an essential member of our technical team and lead all efforts associated with manufacturing of the drug substances and drug products.  You will be working closely with leading contract manufacturing organizations to development technologies that will be fully commercialized.  At Elysium, our mission and goal is to solve the most challenging aspects of health.

Responsibilities

  • Establish CMC development plans from project initiation to regulatory submission
  • Maintain overall CMC budget for product life cycle
  • Select and manage partnerships with contract manufacturing organizations
  • Negotiate favorable master supply agreements, project plans and statement of work documents
  • Oversee technology development and technology transfer
  • Transition products from clinical manufacturing to commercial manufacturing
  • Develop strategic plans for process improvements and implementation of projects within established budgets and timelines
  • Author and review CMC regulatory documents
  • Communicate operational status regularly to senior leadership
  • Enjoy approximately 10%-20% travel

Leadership

You must:
  • Create realistic plans that clearly define goals, responsibilities and results
  • Maintain focus on strategic objectives while accomplishing operational goals
  • Place a priority on getting results with an emphasis on high quality outcomes
  • Make timely and data-driven decisions
  • Encourage collaboration across teams, functions and geographies
  • Ensure that conflict is handled constructively so that performance is not impacted
  • Display a willingness to challenge the status quo and take risks
  • Respond resourcefully to changing business demands and opportunities
  • Maintain optimism and composure in times of change, uncertainty or stress
  • Recognize and reward team accomplishments
  • Possess a strong sense of urgency that drives performance beyond expectation

Requirements
You have:
  • BS/MS in chemistry or chemical engineering
  • Minimum 5 years of related experience
  • Minimum 2 years of management experience
  • Broad knowledge of the pharmaceutical development process
  • Experience with ICH guidelines and FDA regulations relating to CMC development
  • Exceptional problem solving and decision making skills

About Elysium:

Elysium Health’s mission is to solve the biggest challenges in health with science, to help people live healthier for longer. Elysium works directly with top scientists, clinicians and health professionals around the world to translate advances in science and technology into innovative health products that work. Our product development pipeline begins with research and development, continues with preclinical studies, and culminates with human clinical trials to demonstrate the safety and efficacy of products. Throughout this process, Elysium’s focus is to develop compounds found in nature that allow people to support their health proactively.

Elysium is guided by a Scientific Advisory Board, which includes multiple winners of the Nobel Prize, as well as researchers and doctors who are experts in chemistry, physiology, neuroscience, complex chemical systems, biochemistry, and many other fields of study.

Basis, Elysium Health’s first product, is a proprietary formulation of two ingredients designed to support long-term health at the cellular level. Basis is clinically proven to increase NAD+ levels, which decline with age. NAD+ is required for energy creation, regulating circadian rhythms, maintaining healthy DNA, and hundreds of other biological functions.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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