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Director, Manufacturing Science
2 months ago
Position Summary
At Empower, the role of Director of Manufacturing Science & Technology (MS&T), is pivotal to our mission of producing innovative medications that help people live healthier, happier lives. This role is integral in driving the optimization of our manufacturing processes and workflows, ensuring that our commitment to quality, efficiency, and continuous improvement is upheld. You will lead efforts to enhance Right First Time (RFT) rates, reduce waste, and bolster overall product quality.
As the Director of MS&T, you will be at the forefront of technical support for both clinical and commercial manufacturing campaigns. This position requires a deep understanding of technology transfer, process scale-up, and validation, ensuring seamless integration of new processes into our manufacturing operations. Collaboration is key in this role; you will work closely with cross-functional teams including Research and Development (R&D), Quality Assurance (QA), Regulatory Affairs, and Supply Chain to ensure that all manufacturing processes align with our organizational objectives.
In this role, you will ensure compliance with regulatory standards and quality control measures, overseeing the implementation of Good Manufacturing Practices (GMP) and other relevant regulations. Additionally, you will function as a technical subject matter expert (SME) in drug substance and drug product manufacturing, sterile filling, and packaging processes. In this leadership position you will support routine manufacturing and continuous improvement efforts, leading a dedicated team and managing projects from ideation through to completion.
If you are dedicated to innovation, collaboration, and continuous improvement we invite you to apply and join our team at Empower. Your leadership and expertise will contribute to our mission of expanding access to quality, affordable medications and helping people live healthier, happier lives. Be a part of our vision for the future of pharmaceutical manufacturing.
Duties and Responsibilities
Drives efforts to optimize manufacturing processes and workflows to increase RFT, enhance efficiency, reduce waste, and improve quality.
Provides technical support for manufacturing preparation activities for clinical and/or commercial manufacturing campaigns.
Supports technology transfer, process scale-up, process validation, and process optimization activities.
Works closely with cross-functional teams, including R&D, QA, Regulatory Affairs, and Supply Chain, to ensure alignment and integration of manufacturing processes with organizational objectives.
Serves as a technical subject matter expert in drug substances, drug product manufacturing, sterile filling, and/or packaging processes.
Identifies, evaluates emerging technologies, trends in the compounding industry, and implements innovative solutions to drive continuous improvement.
Authors and executes experiments for process development, characterization, and scale-up following the principles of Quality by Design.
Facilitates criticality and risk assessments for manufacturing processes and raw materials, soliciting and incorporating feedback from the appropriate SMEs.
Provides technical support for manufacturing execution and subsequent batch release activities for clinical and/or commercial manufacturing campaigns.
Ensures compliance with regulatory standards and quality control measures and oversees the implementation of GMP and other relevant regulations.
Supports deviations through assessment of impact, reviews & makes recommendations for corrective and preventative actions, and providing input into root cause investigations.
Supports routine manufacturing and continuous improvement efforts through ownership of changes and document revisions (ownership of change control development, planning, execution, and documentation).
Supports execution of Engineering and GMP manufacturing batches (i.e., through document review, technical support, on-floor support, etc.).
Provides leadership and direction to the manufacturing team, fostering a culture of innovation, collaboration, accountability, and continuous improvement.
Completes and communicates annual performance evaluations and provides coaching and feedback to direct reports, recognizing achievements and addressing areas for improvement as needed.
Evaluates department headcount needs and actively participates in interview, selection, and onboarding of new employees.
Manages timelines and deliverables from project ideation through completion.
Performs process performance analysis and trend process performance.
Performs other duties as assigned.
Experience and Qualifications
Bachelor of Science in Biomedical Engineering, Chemical Engineering, Chemistry, or related technical discipline. Advance degree preferred.
2+ years of experience in manufacturing sciences, process development, process validation, or related function within the biopharmaceutical industry (i.e., biologics, vaccines, etc.).
5+ years of substantial experience managing technical operations in a sterile manufacturing environment.
Prior experience with tech transfer, risk assessments, and quality systems in GMP environment.
Knowledge and Skills
Familiar with Food and Drug Administration and European Union regulations and GMP standards.
Possess a sound understanding of engineering fundamentals.
Strong leadership and management skills, with demonstrated experience leading cross-functional teams.
Key Competencies
Customer Focus: Ability to build strong customer relationships and deliver customer-centric solutions.
Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
Resourcefulness: Secures and deploys resources effectively and efficiently.
Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
Ensures Accountability: Holds self and others accountable to meet commitments.
Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
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