Director, Engineering Assembly and Packaging Platform Technical Leadership

Overview Director, Engineering Assembly and Packaging Platform Technical Leadership role at BioSpace. Reporting into the Executive Director Packaging Technical Operations, the Director Packaging and Assembly Platform Technical Leadership is responsible for technical leadership, strategic planning and portfolio execution of key packaging and assembly platforms, with a focus on combination drug products such as prefilled syringes and autoinjectors. The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to accelerate the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Director of Packaging and Assembly Platform Technical Leadership provides deep technical expertise, strong problem-solving capability, strategic acumen, and execution excellence to shape the technical capabilities and strategic direction for a global, cross-modality technical team. Responsibilities Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement. Provide subject matter expertise and ensure scientific rigor, technical problem solving and execution excellence across the assembly and packaging platform portfolio, including data and science reviews and evaluating alternative approaches to meet safety, efficacy, quality, and robust supply standards for platforms (e.g., syringes, autoinjectors, bottles, blisters). Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies. Develop and maintain strong relationships with internal stakeholders (packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, Technical Product Leaders, Value Chain) to facilitate effective technical support and platform stewardship, including support for significant investigations, complaints monitoring and rapid response activities. Develop and maintain KPIs to measure and improve the effectiveness of technical platform stewardship activities and manage the total platform portfolio of work to deliver on priorities. Provide strategic leadership and direction for technical support for the platform stewardship team, including management of ongoing changes and tech transfers for components, equipment, and processes; develop and refine technical platform lifecycle management plans and platform standards. Provide technical guidance to lifecycle changes for packaging platforms, ensuring internal technical requirements are met and filings with regulatory bodies for compliance; apply engineering, medical device and packaging science to deliverables for new product introductions and tech transfers across the network, including alignment of control and validation strategies. Minimum Education Requirements And Experience BS in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years of relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR MS in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years of relevant experience; OR PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years of relevant experience. Required Skills And Experience Subject matter expertise in medical device and combination product commercialization and tech transfer, assembly and packaging process improvement and support from early stage through launch and supply, including components, process, and equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/validation. Demonstrated experience in a leadership role; managing technical teams supporting packaging as well as combination product assembly & packaging. Strong problem-solving and decision-making skills with ability to interrogate the science, identify true requirements, and detect critical flaws including risk identification, gap analysis and mitigation strategies. In-depth knowledge of global regulatory requirements for medical devices and combination products and packaging. Strong understanding of risk management principles, including ISO 14971 and other relevant standards. Strong strategic and analytical thinking with a focus on continuous improvement and best practices in technical support and product stewardship. Excellent communication and interpersonal skills to effectively engage with internal and external stakeholders. Compensation and Work Model Salary range: $153,800.00 - $242,200.00. This range reflects the current hiring range for this role. The actual offer within the range will be based on factors including education, experience, location, and business needs. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will follow a Hybrid schedule (three days on-site per week, Monday-Thursday; Friday remote unless business-critical tasks require on-site). Some roles may require daily in-person attendance or be remote-only. Eligible for annual bonus and long-term incentives, if applicable. Comprehensive benefits are available including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days. More information about benefits is available at the employer’s compensation and benefits page. Equal Opportunity and Accommodation As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other protected characteristics. Reasonable accommodations are available during the application or hiring process. Details on rights under US EEO laws are available through the EEOC Know Your Rights resources. Additional Information San Francisco residents: we will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance. Los Angeles residents: we consider all qualified applicants consistent with applicable state and local laws, including the City of Los Angeles Fair Chance Initiative for Hiring. #J-18808-Ljbffr BioSpace