Senior Director, Technical Operations

Bachem AG•Vista, CA

5d•$141,566 - $194,654

About The Position

To ensure Bachem can meet the demands of its evolving business and diverse customer base, the Senior Director, Technical Operations leads the local Technical Operations organization and ensures that site manufacturing technology, technical capabilities, and operational readiness are aligned with site strategy, customer needs, global standards, and regulatory expectations. The role provides senior leadership for technical operations across manufacturing science, technology transfers, product stewardship, process optimization, validation support, automation and digitalization initiatives, technical documentation, and lifecycle management. The Senior Director, Technical Operations leads scientists, chemists, engineers, technical writers, process specialists, and other technical experts supporting clinical and commercial manufacturing, major capital investments, new product introductions, and transfers within the Bachem network or from client sites to BAM. The role partners closely with Manufacturing, Quality, Engineering, Supply Chain, R&D, Project Management, and global TechOps to strengthen process robustness, inspection readiness, operational excellence, and future site capabilities.

Requirements

Master's Degree in chemical, biochemical engineering, pharmaceuticals sciences or any other chemistry or engineering related fields or PhD in chemical, biochemical engineering, pharmaceuticals sciences or any other chemistry or engineering related fields
10+ years of GMP experience in pharmaceutical, biotech, CDMO, process development, manufacturing science, technical operations, or manufacturing operations, with strong exposure to clinical and commercial manufacturing environments.
5+ years of senior leadership experience in Technical Operations, manufacturing science, process development, or related technical functions, including leadership of cross-functional or matrix teams, technology transfers, process optimization, validation support, technical documentation, lifecycle management, and digital or data-driven improvement initiatives.
Strong knowledge of GMP, quality systems, regulatory frameworks, validation expectations, process safety principles, and inspection-readiness requirements for pharmaceutical manufacturing.
Demonstrated decision-making, analytical, troubleshooting, and problem-solving skills; familiar with Lean Six Sigma, operational excellence, data analytics, trending, and proactive process-monitoring approaches in manufacturing environments.
Proven ability to lead and develop managers, technical experts, and cross-functional teams with diverse scientific, engineering, manufacturing, quality, and documentation backgrounds.
Strong project and stakeholder management skills with the ability to communicate effectively with site leadership, global functions, customers, regulatory interfaces, and external stakeholders.
Good understanding of business financial management, budget planning, CAPEX support, COGS improvement opportunities, and business-case development for technical operations and manufacturing technology investments.
Proven ability to collaborate across multiple sites and functions, influence without direct authority, align stakeholders through matrix leadership, and implement global technical standards in local operations.
Proven ability to build a high-performing Technical Operations organization, develop future-ready talent, drive change, and integrate new technologies, automation, digital tools, and innovation for operational excellence.
Strong technical understanding of manufacturing processes, equipment, technology transfer, product stewardship, lifecycle management, CMC-related technical documentation, FMEA, SOPs, qualification protocols, ERP/MES systems, and process-intelligence tools.

Responsibilities

Ensure adequate technical support for clinical and commercial products through Process Performance Qualification (PPQ), technology transfer, process monitoring, troubleshooting, product stewardship, validation support, manufacturing readiness, lifecycle management, complex troubleshooting, and process optimization activities requiring expertise beyond the capabilities of the Commercial Manufacturing Team (CMT), ensuring robust, compliant, and reliable manufacturing operations.
Lead technology transfer activities including internal site transfers and transfers from client sites to BAM, ensuring robust transfer governance, technical risk assessment, process understanding, validation readiness, clear documentation of transfer requirements and lessons learned. Establish and maintain structured checklists, standards, governance processes, and sustainable knowledge-transfer practices for intra-site and inter-site technology transfers.
Lead and implement efforts to improve manufacturing efficiency, process robustness, and operational excellence for clinical and commercial products, including troubleshooting manufacturing deviations, root cause investigations, process change controls, implementation and effectiveness reviews of CAPAs, data analytics, data mining, trending, process simulations, and digital process-intelligence approaches that strengthen process understanding and monitor commercial process health.
Lead technical support for manufacturing activities, special events, site ramp-up activities, and new product introductions, ensuring effective coordination with Manufacturing, Quality, Engineering, Supply Chain, R&D, and Project Management to support successful execution and operational readiness.
Establish and ensure alignment of technology requirements, technical capabilities, automation and digitalization priorities, and platform technologies with site strategy, future product needs, global standards, and long-term operational excellence objectives while identifying opportunities to leverage emerging technologies and industry best practices.
Serve as a member of the site leadership team and the extended science and technology network, representing Technical Operations in site strategy, global TechOPS alignment, operational readiness, cross-site harmonization of technical standards, risk-management practices, and long-term technical strategy development across the network.
Coach, develop, and retain internal technical talent by building future-ready capabilities, conducting after-action reviews, strengthening knowledge management, establishing best-practice guidelines, fostering accountability, innovation, and continuous improvement, and building a high-performing Technical Operations organization.
Partner with cross-functional and global stakeholders across Supply Chain, Quality Control, Quality Assurance, Procurement, Production, Facilities, Engineering, Project Management, R&D, and Global TechOPS to drive COGS improvement, strengthen risk portfolio management, support regulatory inspections and inspection readiness, participate in GEMBA walks, oversee process-validation and PPQ activities, support pre-approval inspection preparation, and ensure appropriate technical documentation and CMC-related technical content. Promote process safety, equipment stewardship, and a state-of-the-art technical work environment.