Associate Director, Drug Product and Finished Goods MSAT

Overview

The Associate Director, Drug Product and Finished Goods (DPFG) MSAT is the process owner, focusing on drug product and finished goods manufacturing at FDBN. This role sets up and maintains cGMP Aseptic operations and processes for integrating finished goods into the site. During the project phase, leads projects and owns the technical transfer set up and initiation for DPFG. Works closely with the commissioning, qualification and validation organization to ensure all equipment and processes are established and aligned, leads projects to create new processes and expands the capabilities and functionalities into operations. This role supports the Global team providing subject matter expertise level inputs for drug product and finished goods group and ensures the business processes are in place.

External US

Major Accountabilities:

• Builds the DPFG MSAT team in alignment with current directives• Hires, retains, trains, leads and develops a team of DPFG MSAT engineers and technical transfer associates• Manages a team to lead, develop and implement scientifically sound and fit for purpose policies and procedures based on current regulations, industry standards and industry practices for drug product manufacturing, process and technology transfer, and process validation

• Leads the Drug Product and Finished Goods MSAT team in developing and maintaining internal data-focused webapps to support different stakeholders• Provides leadership and direction to the manufacturing site to refine the process requirements for execution• Partners with users (internal and clients) to define functional specifications and process requirements from a specifically process• Partners with users (internal and clients) for data used to support continuous manufacturing and validation, continuous improvement and regulatory commitments• Continuously seeks to optimize the manufacturing processes to ensure effective use of capacity and minimize costs• Partners with Client, Program Design, Quality, Manufacturing and Engineering on platform development, technology innovation, scale-up, and manufacturability as part of technology transfers, as needed• Ensures successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and solving equipment/process issues• Explores, assesses, and recommends new equipment/platforms which improves manufacturing processes from a cost, efficiency, quality, and compliance perspective• Performs tech transfer stage gate reviews on incoming processes/changes to ensure the change is ready for introduction to Manufacturing ensuring manufacturability of the process. This includes acceptable process characterization/validation, risk assessments and mitigation and robust supporting data for the proposed changes. Is responsible for leading all aspects of process validation including: ancillary process validation (both at-scale and small-scale studies as applicable), process performance qualification, and continued process verification, validation master plans, risk assessments, protocols and reports• Develops and oversees a robust technical transfer process supporting at-scale transfer of manufacturing processes between manufacturing partners and locations• Authors or provides guidance to CMC sections of regulatory filings• Supports the CMC review of regulatory submissions, manufacturing site inspections and health authority inquiries• Establishes systems and procedures to enable proactive process monitoring, analysis, and reporting of manufacturing process data• Provides team support for critical manufacturing investigations and technical oversight of deviations, change controls and CAPA's• Resolves technical problems through scientific understanding and application of innovative solutions• Provides team support for investigations, root cause analysis, and optimization with data support and analysis• Functions as senior technical leader and contact for process data and statistics• Leads team in curating critical knowledge and developing best practices in DPFG manufacturing• Serves as a key stakeholder, providing expertise inputs for business development and defining the future large-scale operations model for DPFG• Coaches and mentors direct reports and team members to foster professional development and growth• Enforces and ensures team adheres to company policies and procedures• Participates in the recruitment process to attract talent• Collaborates with other departments (e.g., HR, Talent Acquisition) and provides input to develop retention strategies• Performs other duties, as assigned

 

Minimum Requirements:

• Bachelor’s degree in Life Sciences, Engineering or related field with 10 years of CMC experience leading pre-approval and post-approval activities for biologic product, including process development and/or GMP manufacturi