Associate Director, Device TechnologyMSD Malaysia • Rahway, NJ, United States
serp_jobs.error_messages.no_longer_accepting
Associate Director, Device Technology
MSD Malaysia • Rahway, NJ, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionJob Description Job Summary : The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This position is responsible for building strategic leadership, technical expertise, and managing external partners in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject matter expert on the device components and combination products and lead a cross functional team members to support global commercialization and technology transfer activities and drive product robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance. Essential Duties and Responsibilities : Utilize extensive experience in design controls, device transfer, control strategies, device risk management, and design verification testing to develop value-added solutions for medical devices and combination products. Provide support for the external partner component manufacturing, release and distribution to global manufacturing sites. Identifying issues with minimal signals, problem solving, identification of root cause provide solutions. Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory standards. Ensure robust technical plans, risk communication, drive technical and programs decisions through the development team and governances Support responses regulatory agency questions and pre-approval inspections during a product development and life cycle management Develop and execute strategic plans for technology transfer, problem-solving, leading teams in late stages of development, and working collaboratively with external and internal partners. Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design. Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products. Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs. Build strategic partnerships with manufacturing sites and partner groups Lead, mentor, and enable the team to function as independent contributors, providing support for global and site-specific projects related to combination products and drug delivery systems. Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company's divisional and local site procedures. Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems. Qualifications : Bachelor’s degree in mechanical engineering, Biomedical Engineer, or a related a technical field (e.g., Chemical Engineering, Materials Engineering) required; advanced degree (Master's or PhD) preferred. Minimum of 8 years of experience in pharmaceutical, biologic, medical device or combination product engineering, with at least 4 years in managing external partners and suppliers. Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance. Demonstrated technical leadership in injection molding, automation, complex assembly and packaging operations for medical device or combination product component manufacturing, with experience in autoinjectors, prefilled syringes, and complex drug delivery systems. Exceptional project management skills and principled verbal and written communication abilities, and prior experience leading combination product development teams and working groupsPSCS Required Skills : Business, Combination Products, Device Development, Drug Delivery, Injection Moldings, Management Process, Manufacturing Compliance, Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory Compliance, Regulatory Inspections, Social Collaboration, Strategic Leadership, Technology Transfer Preferred Skills : Current Employees applyCurrent Contingent Workers apply US and Puerto Rico Residents Only : Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.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 : We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. 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”.The salary range for this role is$139,600.00 - $219,700.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.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 .You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only : We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only : We
#J-18808-Ljbffr
serp_jobs.job_alerts.create_a_job
Associate Technology • Rahway, NJ, United States
Job_description.internal_linking.related_jobs
The location of this position is East Hanover, NJ.The Insights and Decision Science (IDS) team is dedicated to enabling improved decision making at Novartis by.
We collaborate closely with the US bu...serp_jobs.internal_linking.show_more
Associate Director of Business Intelligence.Lead the implementation of an enterprise wide analytics strategy utilizing and having expertise in the MicroStrategy Business Intelligence tool, the Snow...serp_jobs.internal_linking.show_more
Radioligand Therapies (RLT) Associate Director, Priority Accounts.This is a field-based and remote opportunity supporting key accounts in an assigned geography.
Novartis is unable to offer relocatio...serp_jobs.internal_linking.show_more
Reporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be responsible and accountable for subject matter expert techni...serp_jobs.internal_linking.show_more
About Axtria Axtria is a global leader in cloud software and data analytics for the Life Sciences industry, empowering organizations to transform their product commercialization journey and i...serp_jobs.internal_linking.show_more
Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey.
Evergreen Theragnostics is an entrepreneurial, agile, growing or...serp_jobs.internal_linking.show_more
WHEN YOU WORK FOR US, WE WORK FOR YOU\n.With Titan Medical, you gain access to thousands of travel nursing and allied health jobs across the country.
You also get unmatched service.From the moment y...serp_jobs.internal_linking.show_more
Zelis is modernizing the healthcare financial experience across payers, providers, and healthcare consumers.We serve more than 750 payers, including the top five national health plans, regional hea...serp_jobs.internal_linking.show_more
Please use Google Chrome or Mozilla Firefox when accessing Candidate Home.By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spi...serp_jobs.internal_linking.show_more
Associate Director, Revenue Accounting - Innovative Medicine and Biosimilars (Gross to Net).Together, we're on a mission to make good health more affordable and accessible, to help millions around ...serp_jobs.internal_linking.show_more
Associate Director / Director plays a key role as clinical technical lead on global Phase I-III and other clinical pharmacology centric projects.
Serves as a team member supporting multiple facets of ...serp_jobs.internal_linking.show_more
Brighton Gardens of Florham Park.The Associate Director of Sales (ADOS) is responsible for supporting and assisting the Sales and Marketing team in achieving the Community’s occupancy and revenue g...serp_jobs.internal_linking.show_more
Reporting to the Head of Finance, Global Manufacturing & Supply, the Sr.Director, Finance Lead Biologics Manufacturing will be responsible for the Platform Finance organization, including oversight...serp_jobs.internal_linking.show_more
Hybrid schedule with flexibility and excellent benefits!.This Jobot Job is hosted by : Doug Goldman.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary...serp_jobs.internal_linking.show_more
Company Overview KMK Consulting Inc.Commercial Analytics, Sales Planning & Operations, and HEOR|RWE.We partner with pharmaceutical and biotech clients to transform complex data into strat...serp_jobs.internal_linking.show_more
Associate Director, Revenue Accounting.Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives.It's a mission that b...serp_jobs.internal_linking.show_more
Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturi...serp_jobs.internal_linking.show_more
Associate Director, Patient Access Strategy - Biosimilars.Parsippany, United States, New Jersey, 07054.Together, we're on a mission to make good health more affordable and accessible, to help milli...serp_jobs.internal_linking.show_more
Associate Director, AI Tech Lead
Novartis Group Companies • East Hanover, NJ, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Associate Director of Business Intelligence
New Jersey Institute of Technology • Newark, NJ, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Radioligand Therapies (RLT) Associate Director, Priority Accounts - Tri- State
USA Jobs • East Hanover, NJ, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
Associate Director, Logistics and Distribution Technology
Hispanic Alliance for Career Enhancement • Rahway, NJ, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Associate Director / Director - RWE (1221)
Axtria, Inc. • Berkeley Heights, NJ, US
serp_jobs.job_card.full_time
serp_jobs.filters_job_card.quick_apply
serp_jobs.last_updated.last_updated_variable_days
Associate Director of Quality Control
Evergreen Theragnostics • Springfield, NJ, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Travel - MRI Tech
Titan Medical Group • 08535, NJ, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
Sr. Director, AI Enablement
Zelis Healthcare, LLC • Morristown, NJ, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Executive Director
American Red Cross • Fairfield, NJ, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Associate Director, Revenue Accounting - Innovative Medicine and Biosimilars (Gross to Net)
Teva Pharmaceuticals USA • Parsippany, NJ, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
Associate Director / Director-Global Clinical Pharmacology
HUTCHMED • Florham Park, NJ, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Associate Director of Sales
Sunrise Senior Living • Florham Park, NJ, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Sr. Director, Finance Lead Biologics Manufacturing
Zoetis, Inc • Parsippany, NJ, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Director, FP&A
Jobot • Woodbridge Township, NJ, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Associate Director, Advanced Analytics
KMK Consulting, Inc. • Morris Plains, NJ, US
serp_jobs.job_card.full_time
serp_jobs.filters_job_card.quick_apply
serp_jobs.last_updated.last_updated_30
Associate Director, Revenue Accounting - Innovative Medicine and Biosimilars (Gross to Net)
Veterans Staffing • Parsippany, NJ, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
Associate Director. Technical Project Management
Merck • Rahway, NJ, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Associate Director, Patient Access Strategy - Biosimilars
Teva Pharmaceuticals • Parsippany, NJ, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted