CMC​/Technical Operations Program Manager - Associate Director

Position: CMC / Technical Operations Program Manager - Associate Director
Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

Location Requirement:
This position may 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 requires periodic travel between both locations to support cross-site collaboration and business needs.

The CMC / Technical Operations Program Manager - Associate Director is responsible for:

• Lead an international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs to deliver all required technical documentation supporting an approvable NDA Module 3 and translate technical & regulatory strategies into execution.

• Project manage all key CMC deliverables, incl underlaying reports, coordinate team interactions ensuring team meetings have structure and purpose, documents clear decisions/actions and communicates them to team members and relevant stakeholders, holds team members accountable for functional delivery of plans

• Assure integrated program plans are in place including cross-functional interdependencies, in particular:

• Facilitates the setting and tracking of program objectives and priorities and monitors program progress against approved project plans (ensures we deliver on time and on budget)

• Coordinates the identification and mitigation of program issues and risks, assures risk mitigation plans

• Build holistic, scientifically sound and relevant scenarios as decision proposal at all governance levels

• Coordinate the review process of technical documents (ie, protocols, reports, master and executed batch records, change controls, deviations, etc.)

• Coordinates the preparation for governance and executive management program presentations in close collaboration with the leadership team

• Responsible for program budget and long-term projections - budget planning and tracking, and evaluates project resource requirements: highlights resource gaps and works to ensure they are addressed

• Follow the invoices and confirm the corresponding work execution to the budget owner
• Other job related tasks

Qualifications

> 8 years of pharmaceutical industry experience, there of:
Significant hands-on experience in CMC Development and Program/ Project Management roles in complex environments and experience in working with cross-functional teams in the pharmaceutical industry, preferably in a global setting

• Excellent Project management skills:
  Decision- and action-oriented to facilitate quick decisions in alignment with all stakeholders, with ability to organize, prioritize and follow-up

• Experience in managing detailed program timelines to ensure timely delivery of key milestones and keeping oversight on complex projects budgets).

• Identify and evaluate risks associated with project activities and take appropriate actions to control or mitigate risks.

Skills/Knowledge/Languages

• Scientific and technical background of CMC development and manufacturing in drug substance small molecule, no-sterile products.

• Demonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision maker

• High level of flexibility and effectiveness in cross-functional,…