About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

Manage process development projects under the guidance of the lead manager and/or director. To be an integral team member who designs and develops robust, scaleable fermentation processes. To be proficient in fermentation scale-up and methodologies, fermenter operation, cell lysis and protein recovery operations. To generate reports and group presentations summarizing the data and activities behind experimental work. Liaising with other departmental scientists to keep moving projects forward. To create tech transfer documents, and edit new SOPs and batch records. To monitor, troubleshoot and provide technology support for production runs at scale. To ensure upkeep of equipment required for lab operations. To maintain a substantial knowledge of state-of-the-art principles and theories and may contribute to scientific literature and conferences. To be involved in regulatory filings and participate on project teams. To manage the work of associates under direct line management and cross-resourced on specific projects. To understand GMP requirements and procedures.

KEY TASKS & RESPONSIBILITIES

• Manage and/or execute experiments in the role of project or unit operation lead for the development & characterization of upstream unit operations.
• Perform and/or manage supporting analytics (in conjunction with direct reports, other lab members or QC).
• Record experiments and results using Patentsafe.
• Generate reports detailing individual experiments and results. Create and archive BPS cell banks appropriately and ensure cell banks are tested as per project timelines.
• Supply BPS Purification with suitable material for downstream studies.
• Deal with issues that arise in the PPL in a timely, proactive manner.
• Understand PPL requirements for processes transferred into the facility.
• Generate development reports for individual and managed activities in the role of project or unit operation lead.
• Present experimental results in group meetings, project meetings (CMC and GPT), and other cross-functional team meetings.
• Manage and/or create tech transfer documents for unit operations developed.
• Participate in teams as required to support MS-BMPD initiatives.
• Track and report group KPIs. Provide and support development plan for direct reports and interns
• Position requires both domestic and international travel up to 20% of time