Description

The following is a job summary of the Associate Director/Director of Small Molecule Manufacturing:

• Plan and execute daily activities in a multi-product clinical manufacturing facility.
• Adopt small-scale models constructed during process development and test at large scale via pilot-scale production in manufacturing to determine whether production models are scalable.
• Coordinate the support of internal and external resources to accomplish production goals with minimal oversight.
• Oversee manufacturing supervisors, lead chemists and technicians including training, daily assignments and perform document reviews and owning deviations and change controls where applicable.
• Provide direction and hands-on training for staff.
• Collaborate with cross-functional teams to resolve technical and logistical challenges e.g.,process development, process transfer and supply chain.
• Foster an environment of safety, quality compliance, strong work ethic and ongoing learning.
• Lead projects related to continuous improvement, operational readiness, and campaign startup/close out during non-production periods and support activities including non-clinical development runs, recipe programming and testing, and maintenance / qualification / calibration.

Note: The position may require off-hour support as needed. Work may include weekends, off hours and holidays.

Key Responsibilities:

• Oversee manufacturing operations, suite and team by coordinating and monitoring activities.
• Provide necessary program direction (tracking and reporting tools) for planning, organizing, developing, and integrating projects across multiple functional areas.
• Mentor and manage a growing team of supervisors, chemists, and technicians.
• Hands-on lead in troubleshooting efforts related to processing and process equipment problems.
• Writes and/or reviews MBR's, SOP's, and other technical documents.
• Ensures operations are in compliance with all Regulatory, EHS, and cGMP quality systems that assure proper design, monitoring, and control of manufacturing processes and suite.
• Manages the raw material needs, production schedules, finished product inventories and logistics of shipments.
• Evaluate and implement new technologies as needed.
• Reporting of KPIs, operational metrics and project updates to SLT.
• Act as a change agent to implement necessary manufacturing suite improvements as dictated by business needs.
• Produce key operations deliverables including URS's, commissioning, start-up, and operator training.
• Maintain Quality System and GMP training requirements.
• Collaborates with the EHS group on environmental, health and safety-related aspects of all operations.
• Participation in multidisciplinary alignment meetings, safety, and quality risk assessments
• Effectively partner with diverse internal stakeholders (process chemistry, analytical development, quality assurance, regulatoryaffairs, manufacturing science and technology, supply chain, quality control, facilities, and manufacturing operators) to build robust processes and supporting resources.

Qualifications

Required Knowledge, Skills and Abilities

• Experience in small molecule chemistry and/or manufacturing preferred.
• >5 years management level experience with ability to develop staff.
• Excellent interpersonal and communication skills
• Ability to influence stakeholders and drive decision-making.
• Proficient in MS Office Software such as Excel, Word, Outlook and PowerPoint.
• Experience in MasterControl eQMS and eBR is a plus.
• Experience in Unicorn, Opti-Dry, Rockwell Studio is a plus.
• Knowledge of chemical engineering principles including reaction kinetics, reactor design, chemical thermodynamics, process modeling, heat, and mass transport a plus.
• Business acumen including experience with Asana, Smartsheet or Microsoft project or equivalent management tool and proven ability to learn and adapt to new systems.
• Understanding and/or experience in chemical process scale-up and manufacturing of pharmaceuticals
• Proven record of calm under pressure and a positive attitude.
• Highly organized.
• Ability to effectively collaborate.
• Outstanding communication skills (verbal and written).

Education and Experience Requirements

Minimum of a Bachelor of Science (BS) in Chemical Engineering, Organic Chemistry, Process Chemistry or Physical Chemistry and a minimum of 10 years of experience within Pharmaceutical or CDMO industries. GMP experience a plus.

Working Conditions

Office environment with some lab/manufacturing environment