Sr. Project Manager, CMC

Company: Winc Australia
Location: Seattle
Posted on: February 23, 2021

Job Description:

This position is primarily responsible for providing project management support to CMC teams, tracking action items and core deliverables, creating project plans, managing meetings, coordination of efforts cross-functionally to meet all program needs. Good things are happening at Omeros! Who is Omeros? -- Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform. What are your job responsibilities?

• Manage 3 - 5 CMC project teams and/or working groups
• Develop detailed CMC project plans that are aligned with the overall program strategy including meeting planning, facilitation and documentation, working collaboratively with project leads and/or department head
• Interacting with internal and external CMC work teams, track action items, core CMC deliverables and decisions using PM tools
• Supports CMC project lead/department head with the optimization of CMC project deliverables (schedules, resources, budgets) including monitoring key deliverables, decision points, demand planning, and critical path activities to drive delivery of objectives
• Gaps analysis and risk management (contingency strategies and solutions)
• Develops an awareness of project management strategies and aligns projects with emerging strategies, methods and processes What education and experience do you need?
  • Bachelor's degree or higher in Biology or Chemistry (Sciences preferred), MS degree is a plus
  • 8-12 years of directly relevant professional experience or education (Project Management, CMC and/or CMO/CRO management) with 3 +years in CMC project management in the pharmaceutical industry
  • Project Management Professional (PMP) Certification is preferred
  • Highly detail-oriented, well-organized, and ability to prioritize multiple tasks to meet deadlines
  • Demonstrated analytical and problem-solving skills including fact based decision-making skills
  • Understanding of GMPs, GLPs and Biopharmaceutical Product Development
  • Understanding of standard CMC contract management
  • Demonstrated proficiency in Microsoft Office, MS Project, and general project management tools
  • Demonstrated ability to work in teams as well as independently
  • Strong interpersonal and communication skills, both written and verbal, along with the ability to be comfortable discussing risks and constraints that could impact project success
  • Effectively manages team meetings and facilitates discussion and decisions
  • Able to moderate complex and/or contentious discussions
  • Must have the ability to build and maintain positive relationships with management, peers, and external clients
  • Ability to deal with ambiguity Physical Demands Required:
    • Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs.
    • May encounter prolonged periods of sitting or standing
    • This position requires working around hazardous materials located within the building If you have the experience, skills and knowledge we are seeking, we'd love to hear from you! This is an exciting opportunity for the right person! Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes. It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to -- hr@omeros.com -- or contact Omeros, asking for Human Resources, at (206) 676-5000 Omeros is a Seattle-based commercial-stage biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, and disorders of the central nervous system

Keywords: Winc Australia, Seattle , Sr. Project Manager, CMC, Executive , Seattle, Washington