Senior Director, Technical Operations

Bachem Holding AG; Vista (CA); Hybrid; USD 142,000 - 195,000; Full time

Benefits offered by this job

Competitive pay

Annual performance bonus

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Job summary

Bachem Americas seeks aSenior Director, Technical Operations to lead the local Technical Operations organization, aligning site manufacturing technology, capabilities, and readiness with site strategy and regulatory expectations.

You will oversee manufacturing science, tech transfers, product stewardship, validation support, and digitalization initiatives, partnering with Manufacturing, Quality, Engineering, Supply Chain, and R&D to strengthen operational excellence.

Qualifications

• Master's or PhD in chemical, biochemical engineering, pharmaceuticals sciences or related field.
• 10+ years of GMP experience in pharmaceutical/biotech with senior operations leadership.
• Strong knowledge of GMP, quality systems, validation, and inspection readiness.

Responsibilities

• Provide senior leadership for technical operations across manufacturing science and tech transfer.
• Lead technology transfers, validation readiness, and process optimization initiatives.
• Drive manufacturing efficiency, deviations investigations, and CAPA governance.
• Coordinate with cross-functional teams to ensure site strategy alignment and operational excellence.
• Support regulatory inspections and ensure robust technical documentation and CMC content.

Skills

GMP knowledge

Lean Six Sigma

Data analytics

Leadership

Cross-functional teamwork

Project management

Technology transfer

Communication with leadership

Budget planning

Regulatory collaboration

Education

Master's Degree in chemical, biochemical engineering, pharmaceuticals sciences or related fields

PhD in chemical, biochemical engineering, pharmaceuticals sciences or related fields

Tools

ERP/MES systems

Job description

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. This position reports to the Vice President of Global Technical Operations.

What you will do

• 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.

Qualifications

• 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.

Annual Salary Range: $141,566.40 - $194,653.80

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

AtBachem, you'll find a diverse, multicultural team. The(a) in the job title stands forall. We welcome applications from all candidates. What matters are your skills and motivation - regardless of age, gender, background, religion, or sexual orientation.