China Production Lead

The China production lead provides end-to-end leadership and oversight for commercial manufacturing and supply execution through external manufacturing partners ensuring reliable supply compliant operations and sustained process performance across product lifecycle stages. This role is accountable for production strategy production supply planning manufacturing readiness startup of external manufacturing operations in China technology transfer process validation support on-site monitoring at CMO/CDMO partners oversight of in-process testing and release testing in partnership with Quality Operations deviation and change management and continuous improvement across drug substance drug product and finished goods operations including oversight of product distribution and warehousing activities performed by CMO/CDMO partners and/or other third parties. As a mandated role for the Market Authorization Holder the position ensures production and associated distribution activities are conducted in accordance with applicable regulatory requirements quality standards and internal governance expectations to support the manufacturing license. The role acts as the senior production representative for external manufacturing operations leading cross-functional decision-making risk management escalation management and cross-functional PO&T projects with internal and external stakeholders and reports to the Regional PO&T Lead. This position also builds organizational capability drives operational excellence and may lead direct and/or matrix teams supporting production oversight and cross functional initiatives.

• Leads end-to-end oversight of production and supply execution at CMO/CDMO sites including production supply planning and on-site monitoring ensuring manufacturing campaigns in-process testing release testing in partnership with Quality Operations and related distribution activities are executed safely compliantly and in line with supply commitments across drug substance drug product and finished goods; directs issue resolution escalation management and operational decision-making to protect continuity of supply and product quality.
• Serves as the production lead for the Market Authorization Holder framework ensuring production systems controls documentation and oversight mechanisms meet applicable regulatory and internal requirements for manufacturing licensing and ongoing compliance; represents production matters during inspections audits and health authority interactions as required.
• Directs manufacturing readiness startup of external manufacturing operations in China technology transfer process validation support production supply planning and lifecycle management activities across drug substance drug product and finished goods operations; oversees in-process and release testing interfaces with Quality Operations and governs change controls deviations investigations annual product reviews and process improvement plans to maintain a state of control.
• Ensure manufacturing process implementing effectively and all related training are carried out and completion as required.
• Builds and leads effective relationships across Technical Development Quality Regulatory CMC Supply Chain and external partners; provides strategic production updates to senior leadership manages cross-functional PO&T projects develops team capability and drives a culture of operational excellence inspection readiness and continuous improvement.

Qualifications:

• Bachelors degree in pharmaceutical sciences chemical engineering bioprocess engineering biotechnology or related scientific discipline; advanced degree preferred.
• Typically 10 years of relevant pharmaceutical or biotechnology industry experience in manufacturing process sciences technical operations or external manufacturing including significant experience in biologics and/or sterile products.
• Demonstrated leadership experience in complex regulated manufacturing environments including oversight of external partners cross-functional teams inspections/audits and regulatory or quality-critical decision-making.
• Professional proficiency in English and Chinese (written and spoken) required to effectively manage collaboration.

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.