CMC / Technical Operations Program Manager - Associate Director at Sobi

Raleigh, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

27 May, 26

Salary

211000.0

Posted On

27 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CMC Development, Program Management, Project Management, Cross-functional Team Leadership, Regulatory Strategy, NDA Module 3 Documentation, Risk Mitigation, Budget Management, Timeline Management, Scientific Soundness, Decision Making, Relationship Building, Communication, Analytical Skills, Small Molecule Manufacturing, Non-sterile Products

Industry

Pharmaceutical Manufacturing

Description

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, 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 Compensation and Total Rewards at Sobi 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. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected] Know Your Rights Sobi Location: United States

Responsibilities

The Associate Director leads an international cross-functional technical CMC team, coordinating with Quality and CMO/CLOs to deliver documentation for an approvable NDA Module 3 and translating strategies into execution. This role involves project managing key CMC deliverables, ensuring integrated program plans, tracking progress against budgets and timelines, and coordinating risk identification and mitigation.