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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.
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:
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:
$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.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aOfficial account of Jobstore.
Job Description
The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Manufacturing Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
These positions provide candidates with great personal/career development opportunities, the opportunity to work on projects having an impact to vaccine manufacturing, and a chance to see if our Company is the right company for their long-term goals. The intern projects vary with current business needs and can be in one or more of the following areas:
VACCINE MANUFACTURING OPERATIONS SUPPORT
Work as part of the team manufacturing life-saving vaccines for counties all over the world
Collaborate with cross-functional teams to improve and/or optimize manufacturing processes
Support/lead projects directly tied to improving the safety and/or compliance performance of the manufacturing areas
IN-LINE AND NEW PRODUCT TECHNICAL SUPPORT
Work with operations and quality groups to maintain products at a high level of performance/compliance through completion of effective investigations, process improvement activities, and other key projects.
Transfer products within our Company's internal manufacturing network or help start up new product and/or manufacturing facilities
Execute strategic technical projects to enhance our World Class Supply posture – decrease inventory, shorten cycle times, lower costs
EQUIPMENT AND FACILITIES MAINTENANCE, DESIGN, AND CONSTRUCTION
Support the design, build, and/or renovation of advanced manufacturing plants, laboratory, and office facilities
Potential involvement with all phases of project management from the first engineering drawing to the last phase of project start up
Work with cross-functional teams to improve reliability of equipment and facilities
Required Education:
Candidates must be Sophomore level curriculum or higher, working toward BS, MS, or PhD in Chemical, Biochemical, Biomedical, Biological, Computer, Electrical, Packaging, or Mechanical Engineering or other related science (Chemistry, Biology, Virology, or Microbiology) or manufacturing related program (Operations Research, Industrial Engineering, etc.).
Preferred Experience and Skills:
Candidates should have pharmaceutical or vaccine manufacturing-related experience.
Candidates should have strong collaboration skills, strong communication skills, lean six sigma experience/ knowledge, and strong project management skills.
Candidates should have knowledge of current Good Manufacturing Practices (cGMPs), some data analytics experience, and strong problem-solving skills.
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.
FTP2024
MMD2024
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:
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”.
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:
Intern/Co-op (Fixed Term)Relocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Shift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aOfficial account of Jobstore.
Job Description
Position Description:
Director, Product Line Technical Lead, Experimental Design and Execution
We are seeking an energetic and collaborative person to join the Research and Development Sciences value team responsible for enabling data and technology products and services that accelerate our scientists’ ability to discover and develop innovative medicines that change the course of human health.
As the technical leader of the Experiment Design and Execution (EDE) product line you will develop and evolve a vision for the suite of products that enable the workflows of scientific experimentation and direct a cross functional team to the successful realization of that vision, solving challenging business problems by bringing together technologies, capabilities, and talent to create products that deliver insight, efficiency, and fantastic user experience. You will help define the standard of excellence in product management in our organization and combine this with your knowledge of drug discovery and development to inspire the cross-functional product organization to deliver value to our scientists.
You will be responsible for identifying opportunities that lead to the growth of our products through constant improvement and innovation while also ensuring consistent delivery and stable operation of products. You will use your knowledge of these products to promote their meaningful use by giving product demos, sharing user stories, and showing the connection of our data and technology products to our mission to serve patients.
Requirements:
Single point of accountability for Experiment Design and Execution (EDE) Product line technology vision, roadmap, and delivery ensuring strong architectural alignment of products in the product line. Proactively seek to understand technology trends, vendor marketplace and upcoming business needs to guide product teams on providing forward looking technology solutions.
Ensure strong architectural alignment of products in the product line with the overall outcomes and success metrics of the Research and Development Sciences value team through setting and managing Objectives and Key Results (OKRs)
Evaluate and provide input into strategic plans for other product lines across the Research and Development Sciences value team, identifying opportunities for experiment design and execution platform products to accelerate value delivery by user-experience product teams through creation of reusable services and capabilities.
Coach, guide, and manage a team of technical leads, engineers, architects across product line to own technology solutions from conception to retirement, aligned with key architectural design patterns
Ensure ongoing compliance with regulatory safety, GMP and Validation requirements. Ensure all systems are designed, built, and operated to full SDLC requirements.
Ensure products within the product are meeting/exceeding business enablement, life cycle management SLAs and adherence to policy compliance procedures with performance metrics in place to track actual relative to goals and identify opportunities for improvement.
Become the key evangelist of EDE products and engage with experts within and outside of our company.
Position Qualifications:
Education Minimum Requirement:
Required Experience and Skills:
Minimum of 10 years in technology product management or in IT leadership roles in complex matrix environments supporting scientific discipline such as biology, chemistry, or computational sciences
Has managed technical product teams and architects. Proven experience in team building, mentoring, and leadership with a demonstrated ability to inspire others to follow a common vision. Ability to function in geographically distributed culturally diverse environment.
Worked with lab management products and technologies such as notebook, lab information management, Sample Management, registration, archiving etc.
Has experience with technical and/or solution architecture, driving better and purposeful decision making on capability and last mile solutions across the value team, experience and comfort making build-buy-assemble decisions as well as technology stack decisions.
Awareness of relevant industry business, information and technology trends in lab systems. Demonstrated knowledge of business processes and industry/market trends within the biopharmaceutical scientific space.
Strong communication skills with ability to align the organization on complex technical decisions. Proven negotiation and guiding through influence skills, along with good problem-solving skills.
Demonstrate strategic thinking skills and an eagerness to learn scientific processes, drug discovery and development processes, regulatory requirements as necessary to solve problems.
Preferred Experience and Skills:
Five or more years in a Drug discovery environment is preferred.
Worked with Product Management tools like Jira, Jira Align, Workboard and has worked in agile methodologies (scrum, Kanban etc.)
Extensive hands-on experience with one or more Inventory & Sample Management solutions, Entity Registration Systems, Lab Information Management Systems, Electronic Lab Notebooks, Request Management and/or Resource Planning systems, Chemical Registration and other laboratory software systems is desired for this position.
Worked with one or many of the following suite of products Titian, Brooks, Dotmatics, Scilligence, Biovia, Revvity, or Benchling software will be added advantage.
Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include Human Resources, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.
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:
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:
$164,800.00 - $259,400.00Available 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.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
naOfficial account of Jobstore.
Job Description
The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. This opportunity within our Manufacturing Division will provide you with hands-on experience in both project and change management, as well as cross-functional collaboration.
Our Manufacturing Division 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.
The Manufacturing Strategy, Business Development and Alliances (MSBDA) group is responsible for the development and realization of the strategy for the Manufacturing division and oversees the core enterprise manufacturing functions. The team designs, executes, and monitors processes required to deliver on our Manufacturing Division strategic portfolio commitments, as well as, managing business development, strategic alliances, and manufacturing network strategy. The organization also provides project, program, and change management support for prioritized projects within the divisional portfolio.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The MSBDA intern will support project management and business realization initiatives led by the MSBDA organization. This individual must be a quick learner with the ability to work efficiently and independently in a fast-paced, dynamic environment. This role requires strong problem-solving capabilities, the ability to synthesize complex data into concise, actionable measures, and the ability to make rapid, sound decisions. The candidate must also demonstrate strong partnership and communication skills to enable interfacing with stakeholders.
The MSBDA intern will complete one or more projects over a 10 to 12-week period beginning late May or early June 2024. This experience will provide you with the opportunity to develop your business acumen, as well as provide you with insight into pharmaceutical manufacturing.
Locations: West Point, PA; Rahway, NJ; Hybrid
Required Education & Skills:
Candidates must currently be enrolled in a minimum of a BS/BA in: Engineering, Supply Chain, Business, Life Sciences, or related disciplines.
Must be available for a period of 9-12 weeks, beginning June 2024..
Preferred Experience & Skills, candidate should have:
G.P.A of 3.0 or higher
Demonstrated ability to quickly learn on the job
Ability to work both independently and in cross-functional teams
Proactive and adaptable in navigating ambiguous and complex environments
Effective problem-solving skills
Excellent interpersonal and communication skills (written and oral), including the ability to build consensus
Strong presentation skills, including advanced PowerPoint skills
Advanced data analytics skills with strong knowledge and experience in Excel or other data analysis tools (ex: Spotfire, Tableau, etc.)
Strong technical competency and a desire to innovate
Previous experience in project management and business strategy
FTP2024
MMD2024
Current Employees apply HERE
Current Contingent Workers apply 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:
Intern/Co-op (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.