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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Reporting to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is responsible and accountable for the packaging development activities from , as well as the strategic management of the development portfolio and organizational unit priorities. This position is responsible for new product packaging development for parenteral products in the human health portfolio covering small molecules, biologics and vaccines.
The leader will manage a group of engineers that are developing packaging for sterile products from conception through successful launch and supply – including the development and engineering of the products, completing and assessing shipping qualification for drug substance, drug product, and final packaging, packaging development and testing, and transfer of a robust design to the packaing site.
The successful candidate will have direct leadership experience and project execution in sterile product development, primary and secondary packaging development, risk management, design for experiments. The succesful candidate will manage a team of engineers working on a portfolio of programs and manage employee development, resourcing, budgeting, technical reviews, escalation and resolution of problems.
The candidate will be expected to build inclusive collaborative partnerships with internal and external stakeholders such as drug substance, drug product, regulatory, project leaders, manufacturing sites, and other key stakeholders in drug product and packaging development. The successful candidate will display ownership and make informed cost/ benefit decisions based on analysis of inputs, outcomes, risks and company-wide prioritization.
Primary Responsibilities include:
Lead the organization and proivde techincal guidance and oversight for engineering of new products
Enhance the processes, methods and procedures for development of sterile products. Provides Leadership in the establishment and gathering of metrics, procedural updates and business systems development.
Works in collaboration with Drug Product, Analytical, and Packaging engineering to ensure thorough engineering and packaging science is applied to deliverables. Builds talent and provides proactive support in training and coaching to cross functional team members as needed to support the development work.
Maintains an expert level of knowledge related to primary and secondary packaging components, comendial and regulatory changes, etc.
Supports preparations for regulatory filings of new products and regulatory inspections
Remains informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards.
Maintains an active network of practitioners and resources in relevant fields of expertise.
Demonstrate financial stewardship in all areas of responsibility.
Education Minimum Requirement:
Minimum of a Bachelor’s degree in mechanical engineering, chemical engineering, packaging science, biomedical engineering, or related disciplines.
Minimum of fifteen (15) years’ experience with B.S./M.S. or seven (7) years’ experience with Ph.D. in pharmaceutical development / engineering or medical device development
Required Experience and Skills**:
The ideal candidate for this position possesses all the following:
Knowledge and understanding of dosage forms and delivery methods, including injection devices for self-administration, primary packaging components, secondary packaging requirements, and cold chain distribution practices.
At least 7 years experience working on Intergrated Development and Supply Teams (IDST) teams or new product development in drug product or packaging development.
Strong leadership skills including team facilitation across multiple functions
Prior people management experience
Ability to complete analysis of complex problems through critical analytical thinking and the design/execution of development plans for new products and new technology, including laboratory/pilot scale experiments
An enthusiasm for collaboration with a diverse set of business partners within research, development, and supply, at a variety of locations within and external to Merck.
Strong interpersonal collaboration and communication skills and the ability to manage projects and lead discussions with partners from other functional areas when conducting risk assessments, designing experimental test plans, and seeking to utilize materials and resources outside the control of packaging commercialization
Strong project and time management skills to allow for the ability to successfully track multiple project assignments at a variety of different stages of development.
Preferred Experience and Skills:
Lean Six Sigma or Design for Six Sigma or Quality by Design technologies. Candidates must also exhibit competency in all Merck Leadership and Inclusion behaviors.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
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Kenilworth, NJ, US
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