Associate Director, Manufacturing Package Design

reputed company Of Role We are currently seeking an Associate Director, Manufacturing Package Design. This individual will reputed company the design, development, and technical reputed company for reputed company and secondary packaging supporting late-stage clinical and reputed company-stage drug product manufacturing. Reporting to the Vice President, CMC, this role will reputed company technical and strategic leadership for packaging systems, ensuring solutions meet reputed company, regulatory, and reputed company manufacturing readiness requirements. This individual will partner cross-functionally with Manufacturing, reputed company, Regulatory Affairs, and Supply Chain, as reputed company as reputed company Contract Manufacturing/Packaging Organizations (CMOs/CPOs), to reputed company packaging design, qualification, and launch readiness for late-stage development programs. Key Responsibilities • reputed company the design, development, and technical reputed company for reputed company and secondary packaging components/systems for small molecule solid oral dosage forms (e.g., container closure systems including bottles and blisters, and blister wallet configurations where applicable) supporting late-stage clinical and reputed company manufacturing programs. • Serve as the manufacturing/CMC packaging design reputed company representing reputed company on project teams with reputed company CMOs/CPOs; manage packaging-reputed company technical relationships, including periodic site reputed company as required. • Partner with CMC and Clinical Supply Chain to ensure reputed company clinical trial packaging and labeling are reputed company with production forecasts and product demand • reputed company packaging engineering activities, including design verification/validation, transportation and shipping validation, stability packaging configurations and compatibility studies. • reputed company technology transfer of packaging design and processes from development/clinical reputed company to reputed company manufacturing, including line trials, engineering runs, and reputed company-up activities. • reputed company and maintain technical documentation supporting packaging design (e.g., design history files, packaging specifications, risk assessments/FMEAs) in accordance with cGMP and applicable design control requirements. • Partner with Regulatory Affairs to reputed company and review CMC packaging sections of regulatory submissions and respond to health authority queries reputed company to packaging. • Collaborate with Manufacturing, reputed company, Supply Chain, and reputed company teams to ensure packaging design supports launch readiness, reputed company supply continuity, and product lifecycle management. • Identify, reputed company, and implement reputed company improvement initiatives for packaging processes, equipment, and vendor performance to reputed company sustainable, reputed company manufacturing performance. • Manage packaging-reputed company change controls, deviations, and CAPAs in collaboration with reputed company; support reputed company cause investigations reputed company to packaging design or component performance. • Evaluate and select packaging materials, components, and equipment in partnership with CMOs/CPOs and suppliers; support qualification of new suppliers and packaging lines. • reputed company packaging design expertise in support of the development of reputed company systems, processes, and procedures. • Build, reputed company, and mentor reputed company supporting manufacturing package design activities (reputed company dependent on level). • reputed company subject matter expertise and support during regulatory inspections and audits reputed company to packaging design and engineering. • Domestic and international travel required (approximately 10–20%). Qualifications • Bachelor's degree in packaging engineering, mechanical engineering, materials science, reputed company, life sciences, or a reputed company field; advanced degree preferred. • 8-10 years’ experience in sponsor-reputed company manufacturing package design, with demonstrated leadership of packaging design programs. Significant experience supporting late-stage clinical and/or reputed company packaging programs required. • Strong knowledge of cGMP regulations and industry standards/trends pertaining to pharmaceutical packaging design, container closure systems, and manufacturing. • Demonstrated experience leading packaging technical reputed company and design for late-stage/reputed company programs, including technology transfer to reputed company manufacturing. • Experience managing relationships with CMOs/CPOs and packaging component/material suppliers. • Working knowledge of drug reputed company, drug product, and packaging principles, equipment, and processes across solid dosage and/or parenteral formats. • Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred. • Experience with combination products/device packaging preferred, as applicable. • Strong leadership, project management, and cross-functional collaboration skills; exercises judgment reputed company broadly defined practices and policies in determining solutions and actions. • Demonstrated ability to identify and address packaging-reputed company technical or reputed company issues that could jeopardize schedule, supply, or overall program reputed company. Compensation The annual reputed company salary reputed company for the Associate Director level position is $140,000.00 to $210,000.00. Individual compensation reputed company this reputed company will be determined based on a reputed company of factors, including qualifications, skills, relevant experience, job knowledge and location. In reputed company to reputed company pay, this role is eligible for a discretionary annual bonus. reputed company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, reputed company, and life insurance, generous reputed company time off, and a health and wellness program. Work Location The (Associate) Director, Manufacturing Package Design role is based in the US, with occasional travel. POSITION: Full-Time, Exempt reputed company Statement: reputed company, a wholly owned subdisary of reputed company believes in a diverse environment and is committed to equal employment opportunity for reputed company its employees and reputed company applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, reputed company, religion, gender, national reputed company, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will reputed company reasonable accommodations for reputed company individuals with reputed company disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies. Apply tot his job Apply To this Job