CMC / Technical Operations Program Manager - Associate Director
Sobi - Swedish Orphan Biovitrum AB (publ), Raleigh, NC, United States
Company Description
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.
Mission And Culture
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 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, including 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, including underlying reports; coordinate team interactions ensuring 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: facilitate the setting and tracking of program objectives and priorities and monitor program progress against approved project plans (ensures we deliver on time and on budget).
Coordinate the identification and mitigation of program issues and risks, assure risk mitigation plans.
Build holistic, scientifically sound and relevant scenarios as decision proposal at all governance levels.
Coordinate the review process of technical documents (e.g., protocols, reports, master and executed batch records, change controls, deviations).
Coordinate 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, 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 Over 8 years of pharmaceutical industry experience, including significant hands‑on experience in CMC Development and Program/Project Management roles in complex environments and experience 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 managing detailed program timelines to ensure timely delivery of key milestones and keeping oversight on complex project 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 in CMC development and manufacturing in drug substance small molecule, non‑sterile products.
Demonstrable experience working in cross‑functional teams 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 The base salary range for this role is $153,000–$211,000. Each individual offer will be determined based on several factors, including 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. Our culture empowers every person to be the one that makes a difference for rare disease.
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 irina.conc@sobi.com.
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Mission And Culture
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 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, including 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, including underlying reports; coordinate team interactions ensuring 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: facilitate the setting and tracking of program objectives and priorities and monitor program progress against approved project plans (ensures we deliver on time and on budget).
Coordinate the identification and mitigation of program issues and risks, assure risk mitigation plans.
Build holistic, scientifically sound and relevant scenarios as decision proposal at all governance levels.
Coordinate the review process of technical documents (e.g., protocols, reports, master and executed batch records, change controls, deviations).
Coordinate 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, 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 Over 8 years of pharmaceutical industry experience, including significant hands‑on experience in CMC Development and Program/Project Management roles in complex environments and experience 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 managing detailed program timelines to ensure timely delivery of key milestones and keeping oversight on complex project 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 in CMC development and manufacturing in drug substance small molecule, non‑sterile products.
Demonstrable experience working in cross‑functional teams 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 The base salary range for this role is $153,000–$211,000. Each individual offer will be determined based on several factors, including 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. Our culture empowers every person to be the one that makes a difference for rare disease.
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 irina.conc@sobi.com.
#J-18808-Ljbffr