Associate Director, Parenteral ExM MS&T

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Job Function

Associate Director, Parenteral MS&T will lead technical support for parenteral manufacturing of BMS products at Contract Manufacturing Organizations (CMO's) primarily based in the US. This position is accountable for the technical interface with Quality, Procurement, Supply Chain, External Manufacturing and Contract Manufacturing Organization (CMOs) to support commercial manufacturing, projects and Technology Transfers for parenteral products. The individual will lead a team of engineers and scientists and will work directly with CMO's. This position is located in New Brunswick, NJ

Responsibilities

• Leadership and hiring of a small technical team of permanent and/or contract scientists/engineers to provide Person-in-Plant support for technology transfers and commercial manufacturing according to business agreements.

• Technical direction and oversight for the External manufacturing (ExM) parenteral network ensuring the delivery of business objectives with our external partners in terms of product delivery.
• Responsible for commercial manufacture support for the ExM parenteral network including resolution of complex technical investigations, change control implementation, delivery of operational targets and technical strategies.

• Management of Process Owner Roles for commercial manufacture support for the ExM parenteral network. This includes process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO, identifying and executing process robustness improvement projects where required.

• Oversight and/or preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of Supplier Proposal requests (RFP), and other business agreements. 
• Provides leadership and technical oversight for technology transfer projects or other related projects in the parenteral ExM environment. Review and approval of top-level site technology documents such as validation masterplans, process risk assessments, etc.
• Member of the global MS&T parenteral team and will have responsibility for driving continuous improvement across the ExM network and within MS&T parenteral aligning with quality and regulatory requirements.
• Optimization of business processes and ways of working to drive team and network performance.
• Review and approval of CMC documentation for health authority responses and regulatory filings.

• Establish relationships to foster collaboration with key stakeholders in partner organizations. Routinely liaising within the MS&T internal BMS network for technical and operational improvements and investigation resolution.

• Participates actively within the extended leadership team to establish team objectives while undertaking supportive actions to drive global network initiatives.
• Role may include balancing multiple responsibilities such as technical oversight of a commercial brand along with oversight of external commercial manufacturing. Leadership and hiring of a small technical team of permanent and/or contract scientists/engineers to provide Person-in-Plant support for technology transfers and commercial manufacturing according to business agreements.
• The position will require varying levels of travel- estimated at 25%.

Required Competencies

• Thorough knowledge of relevant aspects of biologics/sterile/liquid parenterals (Lyophilisation and RTU), fill, finish and inspection operations and associated Quality and Regulatory expectations for filing, approval and Continued Process Verification (CPV).
• Demonstrated successes with