CMC / Technical Operations Program Manager - Associate Director

CMC / Technical Operations Program Manager - Associate Director

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:

• Leading 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 managing all key CMC deliverables, including underlying reports, coordinating 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.
• Assurance of integrated program plans are in place including cross-functional interdependencies, in particular:
• Facilitating the setting and tracking of program objectives and priorities and monitoring program progress against approved project plans (ensures we deliver on time and on budget)
• Coordinating the identification and mitigation of program issues and risks, assures risk mitigation plans
• Building holistic, scientifically sound and relevant scenarios as decision proposal at all governance levels
• Coordinating the review process of technical documents (ie, protocols, reports, master and executed batch records, change controls, deviations, etc.)
• Coordinating 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
• Following the invoices and confirming the corresponding work execution to the budget owner
• Other job related tasks

Qualifications

More than 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, international, and cross-regional environments.
• Proven ability to adapt to an ever-changing business environment.
• Fluent in English, intermediate to full proficiency in Chinese is a plus.

Personal Attributes

• Strategy and operational excellence minded with the ability to quickly define key program priorities, risks and issues, and lead teams in focusing on urgencies and solutions of greatest importance
• Outstanding relationship building and communication skills, including ability to navigate throughout the organization and with individuals at all levels both internally and with external partners
• Ability to lead, manage, develop, and motivate others in a matrix organization and in a changing environment
• Structured and analytical

Additional Information

At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.

The base salary range for this role is $153,000-$211,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.