Merck Associate Director, Combination Product Engineering (Packaging & Combination Product Commercialization) in Rahway, New Jersey

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 Director of Packaging Commercialization, the Associate Director of Combination Product Engineering is responsible for independent support of combination product packaging development in accordance with 21CFR Part 820, as well as the strategic management of the development portfolio and organizational unit priorities. This position will interact with cross functional teams working with all levels of employees. Activities will include developing, documenting, and maintenance of technical business systems, procedures, project deliverables and reporting metrics. The successful candidate will have direct leadership experience and project execution in Medical Device/Combination Product Design Development & Control, Human factors engineering, Combination Product design verification, transfer and validation, primary packaging, device risk management, and Design History Files for programs in clinical development through licensure. They will ensure appropriate design control strategy and document control processes are followed in completion of designated project activities and as per project timelines.

The candidate will be expected to build inclusive collaborative partnerships with internal and external stakeholders such as: commercial manufacturing, commercial planning, analytical operations, clinical research, and other relevant development groups, so an understanding of the relationships between formulation, primary packaging, process, and device design is required. The successful candidate will provide leadership in selecting off the shelf device components including establishing specifications, test method development/validation as needed.

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:

  • Supports execution of combination product development.

  • Participates on Merck cross functional teams to ensure appropriate planning and execution of design controls deliverables.

  • Works in collaboration with Packaging engineering to ensure design and development controls are applied to engineering deliverables.

  • Provides Leadership in the establishment and gathering of metrics, procedural updates and business systems development.

  • Provides proactive support in training and coaching to cross functional team members as needed to support the integration design controls deliverables.

  • Executes work functions in approved formats and as aligned with 21 CFR Part 820 regulations.

  • Supports preparations for regulatory filings of new products.

  • 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.

  • Serves as a technical consultant for development project.

  • Maintains an expert level of knowledge related to 21CFR Part 820 – Design Controls as well as other applicable medical device and combination product standards and regulations.

  • Demonstrate financial stewardship in all areas of responsibility.

Education Minimum Requirement:

  • Minimum of a Bachelor’s degree in appropriate Science or Engineering discipline

  • Minimum of ten (10) years’ experience with B.S./M.S. OR five (5) years’ experience with Ph.D. in pharmaceutical / engineering/ academia with medical device/combination products.

Required Experience and Skills**:

  • Combination product Packaging experience

  • Work experience must demonstrate leadership and expertise in medical device and combination product development

  • Demonstrated patient centered design emphasis and Human Factors experience.

  • Excellent communication skills (both verbal and technical) and interpersonal skills are required.

  • Demonstrated experience in building collaborative partnerships with cross-functional groups both internally and externally.

  • Author/review global Regulatory submissions.

  • Knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for combination products.

  • Experience in developing and commercializing devices / combination products under Design Control (21 CFR 820), ISO13485 quality system requirements (ISO 13485) and execution of Risk Management processes and tools (ISO 14971).

  • Understanding of project management methodologies and demonstrated ability to provide technical leadership for projects of substantial complexity and scope.

  • Must possess independent judgment in developing methods, techniques and evaluation criteria for obtaining results.

Preferred Experience and Skills:

  • Working knowledge of technical aspects of device development and commercialization.

  • Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset.

  • LEAN Management/Manufacturing methodologies

  • Device Risk Management expertise

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 staffingaadar@merck.com .

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Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Packaging Engineering

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Other Locations: NA-US-NJ-Whitehouse Station West, NA-US-NJ-Rahway, NA-US-NJ-Kenilworth

Title: Associate Director, Combination Product Engineering (Packaging & Combination Product Commercialization)

Primary Location: NA-US-PA-West Point

Requisition ID: PAC000295