Director, Assembly and Packaging Platform Technical Leadership

Job Description

Director Packaging and Assembly Platform Technical Leadership

At our company we aspire to be the premier research-intensive biopharmaceutical company. Were at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join us in our mission to make a difference.

Responsibilities

• Lead mentor and develop a team of technical staff fostering a culture of continuous improvement.
• Provide subject matter expertise and ensure scientific rigor technical problem solving and execution excellence across the assembly and packaging platform portfolio.
• Drive proactive risk management activities including risk assessment risk mitigation and risk communication strategies.
• Develop and maintain strong relationships with internal stakeholders to facilitate effective technical support and platform stewardship.
• Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities.
• Provide strategic leadership and direction for technical support for the platform stewardship team including management of ongoing changes and tech transfers.
• Provide technical guidance to lifecycle changes for packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards.

Qualifications

Required

• Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience in pharmaceutical packaging combination product assembly and packaging or related technical fields; OR
• Master of Science (MS) in packaging/ mechanical/ chemical/ biochemical engineering pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience in pharmaceutical packaging combination product assembly and packaging or related technical fields; OR
• PhD in packaging/ mechanical/ chemical/ biochemical engineering pharmaceutical science or chemistry or related fields with eight (8) years relevant experience in pharmaceutical packaging combination product assembly and packaging or related technical fields
• Subject matter expertise in medical device and combination product commercialization and tech transfer assembly and packaging process improvement and support from early stage through launch and supply.
• Demonstrated experience in a leadership role; managing technical teams supporting packaging as well as combination product assembly & packaging.
• Strong problem-solving and decision-making skills with an ability to interrogate the science identify true requirements and detect critical flaws.
• In-depth knowledge of global regulatory requirements for medical devices and combination products and packaging.
• Strong understanding of risk management principles including ISO 14971 and other relevant standards.
• Strong strategic and analytical thinking with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship.
• Excellent communication and interpersonal skills with the ability to effectively engage with internal and external stakeholders.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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 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 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:

EEOC Know Your Rights

EEOC GINA Supplement

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 anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

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 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

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 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 will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.