The Sr. Engineer III will be leading, facilitating, or coordinating all activities pertaining to tech transfer within the Switzerland internal drug substance manufacturing site. Additionally, this individual will lead technology transfer assignments and prioritization for the drug product external network. Responsibilities include creating, updating, and communicating technology (tech) transfer deliverables, managing the overall tech transfer schedule, and tracking applicable tech transfer metrics. The role requires the ability to analyze complex issues and identify opportunities for business process optimization. Effective communication with senior leadership regarding transfer plans, program status, and risk mitigation is essential. The individual will lead large, cross-functional teams towards common goals, articulate departmental priorities to stakeholders, and assist in aligning these priorities. They will also be a key member of the Global Manufacturing Science Technology Transfer team.
What You'll Do
1. Provide leadership for tech transfer at the Switzerland-based drug substance manufacturing site, cultivating relationships with senior leadership and stakeholders to enhance the TT business process. Lead deployment and assignment of technology transfer leaders for the modality.
2. Lead tech transfer efforts for the Drug Product external network from the Baar site, including relationship building and process development.
3. Coordinate and lead tech transfer meetings, attend process sub-team meetings as needed, and manage information flow and decision-making within multiple tech transfers. Activities may include process/facility fit, process introduction, change controls, process transfer, manufacturing readiness, production status, testing reports, material disposition, and project closeout.
4. Serve as a strategic leader and team member of the global manufacturing sciences tech transfer team, providing insights and direction, ensuring adherence to processes, schedules, risks, audits, and escalation procedures.
5. Support reporting and data management for CAPAs, deviations, investigations, presentations, and process optimization. May also provide technical expertise in biopharmaceutical manufacturing or process development to support tech transfers.
Who You Are
You are a highly skilled Scientist/Engineer prepared to lead activities related to technology transfer at our Switzerland drug substance manufacturing site. You possess exceptional leadership qualities, with the ability to build strong relationships with senior leadership and stakeholders. You excel in coordination, managing information flow, and ensuring project adherence and success.
Qualifications
Required Skills
* Educational Qualification: Bachelor's degree with 14 years, Master's degree with 12 years, or PhD with 6 years of relevant experience.
* Leadership Abilities: Proven ability to lead cross-functional teams and engage stakeholders at various levels.
* Communication: Excellent skills to articulate transfer plans, program status, and risk mitigation strategies.
* Project Management: Experience in coordinating meetings, managing schedules, and ensuring project success.
* Data Management: Skilled in managing reports and data to support investigations, decisions, and process improvements.
Additional Information
Why Biogen?
We are a global team committed to excellence and innovation. As a mid-sized biotech company, we offer stability and growth opportunities. Our talented team works together to deliver life-changing medicines. We value inclusion and diversity, fostering an environment where every employee can thrive and contribute to our mission of changing lives.
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