companySobi logo

Associate Director, CMC / Technical Operations Program Manager

SobiRaleigh
Hybrid Full-time

Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.


Unlock Your Potential

Generate Job-Optimized Resume

One Click And Our AI Optimizes Your Resume to Match The Job Description.

Is Your Resume Optimized For This Role?

Find Out If You're Highlighting The Right Skills And Fix What's Missing

Experience Level

Senior Level Manager

Qualifications

> 8 years of pharmaceutical industry experience, including significant hands-on experience in CMC Development and Program/Project Management roles within complex environments, with experience working with cross-functional teams in the pharmaceutical industry, preferably in a global setting. Exceptional project management skills: Decision- and action-oriented to facilitate rapid decisions in alignment with all stakeholders, with a proven ability to organize, prioritize, and follow up effectively. Experience in managing detailed program timelines to ensure timely delivery of key milestones while maintaining oversight on complex project budgets. Ability to identify and evaluate risks associated with project activities and take appropriate actions to control or mitigate those risks.

About the job

Location Requirement:
This position can be based on either the U. S. West Coast (ideally near San Diego, CA) or the East Coast (ideally near Raleigh, NC or Boston, MA). The role necessitates periodic travel between both locations to facilitate cross-site collaboration and fulfill business requirements.

The Associate Director for CMC / Technical Operations Program Management plays a crucial role in:

  • Leading an international, cross-functional technical CMC team, collaborating closely with associated functions such as Quality and impacted CMO/CLOs to ensure the delivery of all necessary technical documentation supporting an approvable NDA Module 3 and translating technical and regulatory strategies into actionable execution.

  • Project managing all key CMC deliverables, including the underlying reports, coordinating team interactions to ensure meetings are structured and purposeful, documenting clear decisions and actions, and communicating them effectively to team members and relevant stakeholders while holding team members accountable for the functional delivery of plans.

  • Assuring the presence of integrated program plans that encompass cross-functional interdependencies.

  • Facilitating the establishment and tracking of program objectives and priorities while monitoring progress against approved project plans to ensure timely and budget-compliant delivery.

  • Coordinating the identification and mitigation of program issues and risks, ensuring comprehensive risk mitigation plans are in place.

  • Building holistic, scientifically sound, and relevant scenarios as decision proposals for all governance levels.

  • Coordinating the review process of technical documents, including protocols, reports, master and executed batch records, change controls, and deviations.

  • Preparing governance and executive management program presentations in close collaboration with the leadership team.

  • Managing program budgets and long-term projections, including planning and tracking, evaluating project resource requirements, highlighting resource gaps, and ensuring they are addressed.

  • Overseeing invoice follow-ups and confirming work execution aligns with the budget owner's expectations.

  • Performing other job-related tasks as necessary.

About Sobi

At Sobi, we recognize that women and underrepresented groups often hesitate to apply unless they meet 100% of the qualifications. We encourage you to break that pattern and apply, as candidates rarely meet every requirement. We are eager to receive your application!Sobi thrives on the unique talents of each individual, collaborating as a team to make a meaningful difference. We are dedicated to developing and delivering innovative therapies to enhance the lives of individuals living with rare diseases. Our strength lies in our team and our unwavering commitment to patients. Our mission and culture at Sobi North America inspire us to come to work every day. Here are a few more reasons to consider joining our team:Competitive compensation packageGenerous time-off policyOpportunities for professional development through attendance at popular conferencesFocus on work/life balanceCollaborative, team-oriented environment

Similar jobs

Tailoring 0 resumes

We'll move completed jobs to Ready to Apply automatically.