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CMC Project Manager

Neumora Therapeutics

Neumora Therapeutics

Operations
Remote
Posted on Tuesday, February 6, 2024

At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.

The CMC Project Manager uses knowledge of drug development to plan and track the progress of CMC projects/programs and ensure CMC and TechOps cross-functional readiness for regulatory filings and clinical/commercial product supply.

Responsibilities:

  • Create and manage integrated timelines with cross-functional teams, including Technical Operations, Quality, Regulatory CMC, Supply Chain, etc. to meet Program Team timelines
  • Facilitate cross-functional workshops and review meetings to identify interdependencies of activities and critical path items, and support scenario planning for activities
  • Liaise with internal functions to map out activities for product market launch incorporating regulatory, quality, supply planning, analytical development, global change control, manufacturing, and quality control
  • Utilize program management tools to ensure programs meet scope, budget, and timeline while ensuring quality
  • Support the development of 2-5 year strategic CMC program plans, working with the cross-functional team to align and communicate the integrated CMC strategy
  • Engage senior management to raise potential CMC opportunities and risks with proposed mitigation plan
  • Serve as primary point of contact between cross-functional areas to facilitate the advancement of programs; “connect the dots” across the organization
  • Develop project management tools and mechanisms for monitoring CMC progress
  • Proactively track and report API and DP inventories, manufacturing schedule and progress at the CMOs
  • Submit and manage purchase orders in NetSuite and work with Finance to report spending progress and gaps against budget

Qualifications:

  • BS/BA in a related field
  • Background in Chemical Engineering, Chemistry or Life Sciences is preferred
  • 5+ years of pharmaceutical industry experience
  • Project/program management experience, CMC planning, supply chain experience or combination
  • Experience using project management tools and templates (e.g., Smartsheet, MS Project, etc.)
  • In-depth knowledge of Drug Development and FDA, EMA, GMP, GCP, and ICH regulatory requirements
  • Excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary environment
  • PMP certification or MBA a plus

Company benefits include:

  • Medical, dental, vision, and life insurance
  • 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
  • New hire stock options
  • Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
  • Leave of Absence: Paid family leave, paid short- and long-term disability
  • Discretionary year-end bonus

The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $125,880- $140,495/year

Neumora Therapeutics is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of multiple clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.

Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.