Senior Manager, CMC Project Management

Responsibilities

• Provide project management support to CMC teams for projects ranging from Pre-IND through different phases of clinical development and commercialization.
• Track CMC timelines, deliverables and other relevant documents.
• Collaborate with team members in PDM, QA, clinical and non-clinical development teams to ensure project activities are progressing within established timelines.
• Collaborate with the Regulatory Affairs team to track, coordinate, and communicate CMC regulatory filing timelines as needed.
• Collaborate with CMC leads to plan and facilitate regular and effective CMC project meetings with structured agendas and accurate meeting minutes; follow up on action items.
• Proactively identify potential key issues and communicate with key stakeholders and management in a timely manner.
• Provide project management support to enable oversight of the development activities outsourced to CDMO(s) as needed.

Requirements

• B.S with 10+ years/M.S with 5-8 years/Ph.D with 3-5 years experience in Pharma/Biotech industry.
• Strong CMC project management experience for development projects spanning various phases of development with a good understanding of the drug development cycle, regulatory filings experience a plus.
• Knowledge of current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, GMP guidelines, and related industry practices.
• Demonstrated experience working in cross-fuctional teams and effective communication across multiple functional areas.
• Effective written and verbal communication skills and interpersonal skills.
• Ability to interpret complex project information and identification of potential timeline and project risks.

Preferred Skills

• Small molecule development experience.

Qualifications

• B.S. or M.S. or Ph.D. degree in Pharmaceutics, Chemistry, Chemical engineering or closely related field is desirable.

Benefits

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Pay

Base Pay Salary Range $164,000 - $205,000 USD

Schedule

Full-time