Associate Director, Packaging Engineer

Role Details

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Position Description:

Reporting to a Director of Packaging Commercialization, the Associate Director, Engineering, Packaging Commercialization will lead activities in support of packaging development of new oral solid dosage and parenteral products in the human health portfolio covering small molecules, biologics and vaccines.

Through participation on a New Product Development and Commercialization Team and on functional working groups, the successful candidate will build inclusive, collaborative partnerships with internal and external stakeholders from drug substance, drug product, analytical, regulatory, quality, supply chain, and marketing areas, as well as partners at the packaging manufacturing sites.

The successful candidate will lead Packaging Working groups and will be responsible for the development of primary, secondary and tertiary packaging for non-sterile and sterile drug substances, drug products and devices from conception through successful launch and supply to ensure the transfer of a robust design to the packaging site.

Packaging development responsibilities may include selection of primary packaging material, determination of package images to support commercialization incorporating user experience, technical, regulatory and business requirements into the packaging development process to ensure development of optimal packages. The successful candidate will ensure technical qualification of all packaging components including primary, secondary, tertiary packaging are met through protocol design and qualification including shipping distribution studies to test robustness of packages. The successful candidate will design and testing of packaging components and author packaging specifications for primary, secondary and tertiary packaging as well as relevant sections of NDA’s, WMA’s, and JNDA’s interfacing with Packaging Site Operations and External Manufacturing on development line trials, and Packaging process Qualification. Finally, the successful candidate will ensure packaging is compliant with rapidly evolving environmental regulations and corporate goals for sustainable packaging.

The successful candidate will have strong technical and analytical skills, and will be passionate about problem solving and technical troubleshooting to aid in assessing technical, regulatory, and business risks and benefits for complex projects in a fast paced environment.

The successful candidate will display ownership and use scientific excellence and strategic decision making to make informed decisions based on analysis of inputs, outcomes, risks and company-wide prioritization.

The successful candidate will also seek to understand the product and packaging requirements of physicians, patients and payers

Education Minimum Requirement:

• The successful candidate will have a completed a B.S. or higher degree in relevant fields which include Packaging Engineering, Packaging Science, or Chemical Engineering with a minimum of 15 years of relevant Pharmaceutical development experience

Required Experience and Skills**:

• Demonstrated understanding of pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components

• Demonstrated understanding of Medical Device and Combination Product regulations

• Demonstrated understanding of the use of Design of Experiments (DOE) and Risk Assessment tools

• Demonstrated ability to work both independently and as part of a larger team

• Demonstrated experience in leading cross-functional groups both internally and externally

• Demonstrated project management experience and ability to provide technical leadership for complex projects while managing multiple projects in a fast paced environment

• Excellent technical written and oral communication skills that support presentation of information clearly and concisely for all levels of the organization

• Demonstrated knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging

• Strong interpersonal skills and the demonstrated ability to influence senior leaders

• Ability to manage complex programs and support multiple activities/projects

• Willingness to grow and learn all areas of Pharmaceutical new product development

Preferred Experience and Skills:

• Direct people management and behavior coaching experience

• Experience specifying, processing and characterizing packaging materials including rigid and flexible barriers, pulp/paper-board and recyclables

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

Residents of Colorado

Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

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.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Under New York City, 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:

$118,640.00 - $186,800.00

Available 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 (https://www.benefitsatmerck.com/) .

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid, Remote Work

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID: R235806

Merck provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.