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Job Description
Our company is currently seeking a subject matter expert in packaging design, development and qualification in support of combination product images ranging from pre-filled syringes, inhalers, auto-injectors and other complex drug delivery systems. This position will be part of our company's Device Development department responsible for combination product and process development for all of our company's drugs, biologics and vaccines requiring delivery devices. The scope of the role includes design and qualification of the primary packaging interface of the drug delivery device in support of clinical product supply. Additionally, the role includes the design and optimization of trays, bulk packaging, and other interfaces for device components in support of shipping and feeding for assembly operations. The intermediate and final combination product clinical package will have line-of-sight to the commercial configuration when feasible. In these situations, the early development and clinical packaging designs must include commercial design and manufacturability considerations.
This role will partner with the working groups within the department and across the organization to design and develop the packaging interface for the drug delivery device system with intimate knowledge of the delivery device design in support of clinical supply, distribution and use. Testing of the packaging interface will be conducted (or coordinated with external facilities) to assess the suitability of the design through phase-appropriate evaluations. The successful candidate will need to collaborate effectively with both the global clinical supply operations team as well as packaging commercialization and technology teams to ensure robust machinability and shipping/distribution performance is built into the packaging design. Deep knowledge of shipping study standards and guidance, as well as medical device design controls, device risk management, design verification and human factors considerations is critical.
Responsibilities
Serve as a subject matter expert in packaging design and evaluation to a diverse team of engineering professionals in support of clinical and commercial product development
Collaborate highly effectively with internal partner groups including drug product development, analytical development, manufacturing, technical operations, packaging, quality, regulatory affairs, and clinical supplies to deliver robust combination product manufacturing processes and product quality control strategies
Establish, develop, and maintain strong business relationships with external packaging design and component suppliers
Actively participate on Device Working Groups to extract technical requirements and development timelines for all combination products in the company'sportfolio to inform on packaging design and development strategies
Actively represent Device Development externally as a member of professional committees and at relevant conferences/consortia across the industry
Required Experience & Skills
B.S. in Packaging, Mechanical, Biomedical, or related Engineering discipline
15+ years of experience in the medical device, pharmaceutical and/or combination product industry
Experience partnering with packaging development and equipment suppliers
Experience partnering with packaging test labs
Prior direct responsibility for designing, developing and evaluating packaging solutions for drug-device combination products or medical devices
Good Manufacturing Practices (GMP)
ASTM D3475, ISO 11607, ISO 15378. ISO 18601 ISO 9001, General Simulation Performance Tests ISTA 3A, European Committee for Standardization (CEN), Notified body requirements and relevant standards
Experience in authoring relevant packaging related content of clinical and registrational regulatory submissions
Preferred Experience & Skills
Experience in product design, concepting and prototyping
Experience with medical device development including an understanding of 21 CFR Part 4, Design Controls (21 CFR 820.30), Purchasing Controls (21 CFR 820.50), Corrective and Preventative Actions (21 CFR 820.100), Production and Process Controls (21 CFR 211 Subpart F), as well as ISO 13485, ISO 14971, and EU 2017/745 (MDR)
Excellent problem-solving capabilities
Strong decision-making skills, weighing advantages, disadvantages, and business impact for rapid decisions
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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, generally Tuesday, Wednesday and either Monday or 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”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$149,400.00 - $235,100.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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