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Pharmaceutical Sciences & Clinical Supply (PSCS) is the group responsible for developing the composition and manufacturing processes for all drug product formulations within our Company.
PSCS has created a stimulating, diverse and creative culture and is an industry leading organization with the following key cultural attributes: a culture of scientific excellence where staff feel enabled to take technical risks to drive the pipeline and influence the external scientific and regulatory communities; a culture strong on people development where diversity in all manifestations is respected and valued; a culture where future leaders are being developed with requisite leadership and technical foundations to significantly influence drug development within Research & Development; a culture in which innovative drug delivery is championed for pipeline value creation to position the company with options that fully take advantage of our treatments for the betterment of patients, examples include fixed-dose combinations, cutting edge oral and non-oral delivery modalities, and devices; and lastly a work culture where individuals are intellectually stimulated, challenged, continuously learning and having fun surrounded by world-class colleagues.
The major sub-functions of PSCS include: Drug delivery, responsible for composition and process design for all routes of administration and modalities from discovery to transition to manufacturing; Pharmaceutical Operations, responsible for pilot plant manufacturing of clinical trial materials; Global Clinical Supply, responsible for packaging, labeling and shipping logistics for all clinical trial materials within our Company; and Device Development & Technology, responsible for developing and commercializing a wide variety of drug delivery devices to support all therapeutic modalities in the pipeline.
In addition to supplying formulations to support our Company's pipeline products, PSCS also prides itself in proactively identifying innovative drug delivery solutions for alternate delivery approaches and lifecycle management opportunities to create value for patients.
As our company's pipeline demands an increasing need for device-enabled delivery, we are enhancing our investment in our Device Development and commercialization capabilities. The Device Development & Technology team has a mission to optimize product market image and patient outcomes across global markets. The group manages all aspects of delivery Device Development from strategic design concept through prototyping and tooling development through assembly automation, qualification, and technical transfer to global commercial manufacturing sites. The team also has the important responsibility for enabling supply continuity, commercial product investigations and product lifecycle management.
Within Device Development, product stability, safety, dose delivery, process engineering, manufacturing and patient convenience are proactively engineered and integrated into the Product Market Image for global markets through close interaction with a variety of stakeholders, including: marketing, quality, procurement, regulatory affairs, supply chain, manufacturing site, external partners and manufacturing technical operations.
Primary Responsibilities:
Education Requirement:
Required Experience and Skills:
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.
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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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.
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, 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:
$285,920.00 - $450,000.00
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.
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Pharmaceutical Sciences & Clinical Supply (PSCS) is the group responsible for developing the composition and manufacturing processes for all drug product formulations within our Company.
PSCS has created a stimulating, diverse and creative culture and is an industry leading organization with the following key cultural attributes: a culture of scientific excellence where staff feel enabled to take technical risks to drive the pipeline and influence the external scientific and regulatory communities; a culture strong on people development where diversity in all manifestations is respected and valued; a culture where future leaders are being developed with requisite leadership and technical foundations to significantly influence drug development within Research & Development; a culture in which innovative drug delivery is championed for pipeline value creation to position the company with options that fully take advantage of our treatments for the betterment of patients, examples include fixed-dose combinations, cutting edge oral and non-oral delivery modalities, and devices; and lastly a work culture where individuals are intellectually stimulated, challenged, continuously learning and having fun surrounded by world-class colleagues.
The major sub-functions of PSCS include: Drug delivery, responsible for composition and process design for all routes of administration and modalities from discovery to transition to manufacturing; Pharmaceutical Operations, responsible for pilot plant manufacturing of clinical trial materials; Global Clinical Supply, responsible for packaging, labeling and shipping logistics for all clinical trial materials within our Company; and Device Development & Technology, responsible for developing and commercializing a wide variety of drug delivery devices to support all therapeutic modalities in the pipeline.
In addition to supplying formulations to support our Company's pipeline products, PSCS also prides itself in proactively identifying innovative drug delivery solutions for alternate delivery approaches and lifecycle management opportunities to create value for patients.
As our company's pipeline demands an increasing need for device-enabled delivery, we are enhancing our investment in our Device Development and commercialization capabilities. The Device Development & Technology team has a mission to optimize product market image and patient outcomes across global markets. The group manages all aspects of delivery Device Development from strategic design concept through prototyping and tooling development through assembly automation, qualification, and technical transfer to global commercial manufacturing sites. The team also has the important responsibility for enabling supply continuity, commercial product investigations and product lifecycle management.
Within Device Development, product stability, safety, dose delivery, process engineering, manufacturing and patient convenience are proactively engineered and integrated into the Product Market Image for global markets through close interaction with a variety of stakeholders, including: marketing, quality, procurement, regulatory affairs, supply chain, manufacturing site, external partners and manufacturing technical operations.
Primary Responsibilities:
- The Associate Vice President, Device Development & Technology will lead our end-to-end Device Development and commercialization team and will be a recognized leader in the field with the necessary experience and leadership skills to build talent, set strategy, deliver tangible results and continuously improve our business processes.
- Possess strong expertise, people leadership skills and a track record of success in developing combination products from development through commercial supply lifecycle support.
- Advance a well-conceived drug-device combination product that adds value to both the patient and the healthcare system.
- The incumbent should have a track record in driving innovative expertise in drug device combinations including experience with intellectual property creation in these areas.
- Experience in managing an effective "end to end" integrated drug device combination team would be valuable.
- Demonstrated experience collaborating across a broad range of stakeholders and in change management, process improvement and implementation of new workflows/ processes.
- Deep understanding and appreciation of the interaction of formulation and the device, integrating solutions across formulation, process, and device assembly for robust launch and supply.
- Develop and retain top talent in the organization while empowering others to drive necessary change to achieve industry-leading excellence.
Education Requirement:
- BS/BE/BA required, advanced engineering degree preferred (MS/ME, PhD)
- Continued education relevant to drug device combination product engineering
- 10+ years of experience in drug device combination product leadership role
- 5+ years of management experience
Required Experience and Skills:
- Deep scientific expertise and reputation in drug device combination products
- Organizational understanding and sensitivity facilitating cross divisional collaboration and execution
- Lead external relationships and engage strategically with, regulators, customers, CROs, and KOLs to keep a pulse on market trends and anticipate needs for business.
- Inspire, motivate, and facilitate innovation to deliver the best science & engineering to meet business and patient needs
- Advocate diversity, equity, and inclusion with a multicultural/ multigenerational workforce
- An entrepreneurial approach to business and problem solving, leveraging internal and external capabilities.
- Drive to conceive, create, and advance new products within our company's portfolio, as well to grow and defend existing products through lifecycle management by proactive problem-solving and issue resolution.
- Confidence in taking risks and deploying resources in advance of formal sanctions/approvals (making smart bets)
- Ensure readiness for robust manufacturing and reliable supply throughout the lifecycle of the device
- Be a matrix leader with an ability to influence without authority, collaborating with key stakeholders
- Ability to inform and drive our company's investment strategy, internally and externally pertinent to devices
- Strong business acumen and strategic product positioning
- Ability to manage ambiguity and complexity within a dynamic portfolio
- Executive presence and business acumen
- Broad understanding of Device Development and regulatory processes, across both development and commercial supply space.
- Extensive experience and proven track record in leading the development of drug device combination products of various types/complexity.
- Demonstrated ability to work cross functionally and develop business relationships (regulatory, quality, manufacturing, etc.) and effectively collaborate with both internal and external stakeholders.
- Experience directly influencing business partners, prioritizing resources, and addressing lifecycle needs related to device performance.
- Experience leading external relationships and engaging strategically with, regulators, customers, CROs and KOLs.
- Advanced understanding of global regulatory requirements and processes governing the development and registration of devices.
- Direct experience with relevant regulatory agencies (FDA, EMA, PDMA, etc.).
- Experience in the creation and defense of intellectual property.
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.
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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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.
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, 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:
$285,920.00 - $450,000.00
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.
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
