Director, Assembly and Packaging Platform Technical Leadership

Director Packaging and Assembly Platform Technical Leadership 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. Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies. Develop and maintain strong relationships with internal stakeholders to facilitate effective technical support and platform stewardship. Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities. Provide strategic leadership and direction for technical support for the platform stewardship team, including management of ongoing changes and tech transfers. Provide technical guidance to lifecycle changes for packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards. Qualifications Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR Master of Science (MS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields 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. 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 an ability to interrogate the science, identify true requirements, and detect critical flaws. 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 driving continuous improvement and implementing best practices in technical support and product stewardship. Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders. Work Model U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". Salary $156,900.00 - $247,000.00 Benefits We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at . EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement #J-18808-Ljbffr