Sr. Manager, Upstream Process Technology

About This Role:

As the Sr. Manager of Upstream Process Technology within the Manufacturing Science and Technology (MSAT) team, you will be the key technical leader and innovator for our upstream process technology at our dynamic site. Your expertise will be pivotal in coordinating with various department leads, scaling up process technology, and ensuring scientific leadership in lab studies and operations. This role is not just about maintaining the status quo but pushing the boundaries of upstream process technologies to enhance robustness and productivity. You will be at the forefront of technical support for post-approval and commercial manufacturing campaigns, shaping our strategic collaborations with other sites and global technical functions. Your decisions and leadership will directly impact our clinical operability, commercialization, productivity, and the quality of our drug substance operations. You will be an integral part of our team, reporting to the Head of Global Manufacturing Sciences and liaising with a diverse range of stakeholders across the organization.

What You’ll Do:

• Serve as the site's key technical lead in USP process technology, collaborating closely with manufacturing, process engineering, and biological engineering services.
• Coordinate technical expertise for the scale-up and transfer of downstream processes and oversee process science technical SME activities.
• Lead process scientific efforts for laboratory studies, investigations, and maintain lab support for site operations.
• Provide technical leadership for pre-approval and commercial manufacturing campaigns, managing deviations and CAPAs efficiently.
• Foster strategic alliances to transfer and advance USP process technologies, enhancing robustness and productivity.
• Author and review scientific and technical reports, protocols, and regulatory documents, ensuring compliance and excellence.
• Engage with regulatory audits and internal quality organizations for process and batch review and approval.
• Analyze data to support process science studies and drive process improvements.
• Oversee technical projects and lab studies that add value to the drug substance site.
• Communicate the status of batch activities, deviations, and process transfer deliverables to management and partners.
• Manage the PFDs and PCDs for all LSM and SSM products, implementing changes related to transfers, GCCs, and CAPAs as needed.

Who You Are:

You are a technical maestro in upstream process technologies with a penchant for driving innovation and efficiency in biopharmaceutical manufacturing. You thrive in environments that challenge you to coordinate complex technical projects and cultivate strategic collaborations. You are skilled in data analysis and possess a keen eye for detail, enabling you to provide insightful process improvements. Communication is your forte; you articulate complex technical details with clarity to stakeholders at all levels. Resilient and proactive, you are adept at leading through change and uncertainty, ensuring the highest standards of quality and regulatory compliance.

Required Skills:

• Bachelor’s or Master's Degree in a relevant technical discipline.
• A minimum of 10 years' experience with a Bachelor's degree or 8 years with a Master's degree in the biopharmaceutical industry.
• Demonstrated project management, technical writing, and communication skills.
• Proven ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy.
• Strong presentation skills and experience working collaboratively in a team environment.
• Practical knowledge and application of cGMP and familiarity with FDA/EMA regulations and inspections.
• Experience interfacing with regulatory inspectors and/or agency personnel.

Preferred Skills:

• Advanced problem-solving and decision-making capabilities.
• Strong leadership qualities with a track record of mentoring and developing teams.
• Expertise in technology transfer and commercial operations activities.