Job Details

ID #2800446
Estado Wisconsin
Ciudad Madison
Full-time
Salario USD TBD TBD
Fuente Merck
Showed 2019-10-22
Fecha 2019-10-23
Fecha tope 2019-12-21
Categoría Etcétera
Crear un currículum vítae

Director, API Technology & Portfolio Development

Wisconsin, Madison 00000 Madison USA

Vacancy caducado!

Job DescriptionOur 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.Reporting to the Head of the API Technology Portfolio Management as part of Global Technical Operations for Animal Health, the Director will be part of the API Technology Portfolio Management Group, and will be responsible for a portfolio of Active Pharmaceutical Ingredient (API) projects and or supply nodes with a focus R&D Projects and coordinating the R&D portfolio. The potential project types include sourcing, technical transfer, R&D, process improvement, and trouble shooting. The role is global and the individual will be part of a global team. Critical Skills include Technical, project management, verbal communication, and electronic communication.At the director level, the individual will be eligible for advanced projects, deep trouble shooting and innovation projects. A focus will be placed on coordinating the contract manufacturing and generic activity and will include owning a portfolio of Research and Development projects. The individual will be a technical lead during API sourcing, will be an end to end leader of the contract manufacturing project execution after supplier selection, and will be a leader of supplier technical management for complex relationships. They will be expected to generate innovations with the supply base and lead global initiatives as required.Your role at our Company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our Company, we’re inventing for life.Responsibilities include but are not limited to:

Leveraging external API suppliers to provide material primarily to our Company Animal Health internal formulation facilities across the world.

Enhancing the function through Operational excellence projects.

End to end leadership of a contract manufacturing technical transfer after supplier selection including managing all aspects of the interface with the supplier and with the internal of our Company Animal Health departments.

Maintaining project schedules, call regular global meetings with the needed departments to manage the relative work streams, and hold sponsor meetings to communicate the project status and request support at stage gates.

During global sourcing leading to supplier selection, the individual will be expected to partner with External Manufacturing & Global Procurement organization of our Manufacturing Division Animal Health and the different Animal Health departments.

During the sourcing phase of a project, the individual will be a technical lead on the sourcing team and be responsible to define the requested services and physical properties including generating technical packages, leading technical due diligence for supplier selection, planning formulation and regulatory timelines, and verifying that the evaluation of the supplier is balanced.

A close partnership with procurement and formulation site leads during the sourcing process is important and knowledge of the importance of physical properties on formulation success is needed.

Technical strength will be needed in areas such as process chemistry, process engineering, analytical chemistry, physical property engineering, environmental, Industrial Hygiene, and regulatory. Strong business acumen and partnership with procurement will be expected to ensure financial targets are met and contracts are managed well.

A close partnership with procurement and formulation site leads during the sourcing process is important and knowledge of the importance of physical properties on formulation success is needed.

For inline supply, Supplier Technical Management (STM) will be conducted to ensure the on time and full delivery of API to our Company Animal Health.

Leading cross functional meetings with the external suppliers and Internal in our Company personnel to monitor the technical aspects of the relationship including tracking all changes, deviations, and improvement projects.

Lead the process change team inside of our Company Animal Health working closely with our formulation facilities, regulatory, and quality in order to execute changes at the supplier

Following up on deviations and ensure resolved quickly and appropriately

Ensuring appropriate knowledge management of API technology

Developing and pursue innovation projects with the supplier as appropriate

Leveraging appropriate software systems including for supplier communication and change control

Providing strong leadership and business acumen for project management and lead cross-functional team members effectively

Displaying our Company leadership behaviors and demonstrate a high emotional intelligence

Creating and ensuring the overall project schedules including regulatory and formulation site inputs are appropriate for the project delivering end to end outcomes

Working closely with external suppliers to assess the chemistry and processing equipment and limit risk on transfer

Evaluating material physical property and chemical comparability and mitigate risk.

Presenting status updates in the API Governance forum

As required, the individual will assist communications with the suppliers during trouble shooting or visit facilities to conduct due diligence.

Technical strength will be needed in areas such as process chemistry, process engineering, analytical chemistry, physical property engineering, environmental, Industrial Hygiene, and regulatory. Strong business acumen and partnership with procurement will be expected to ensure financial targets are met and contracts are managed well.Education Minimum Requirement:

PhD in Chemistry or Chemical Engineering or comparable appropriate for API technical understanding.

Required Experience or Skills:

Minimum 10 yrs. of relevant experience

Experience with chemical processes or a demonstrated high level of technical capability

A strong business acumen, communication skills, and a proven track record of managing projects in the areas of sourcing / commercialization / tech transfer / chemistry process trouble shooting supply of API products

Strong Leadership attributes including a global mindset

Demonstrated ability to lead cross-functional teams with an end to end supply chain view

Ability to collaborate across functions and geographies and support global activities

Strong interpersonal skills

Ability to maintain strong working relationships with technical, quality and operations leaders in the internal and external network

Experience using Microsoft Project

The ability to travel up to 30%

Preferred Experience and Skills:

An understanding of the technical characterization or product physical properties and familiarity or expertise with chemistry and finishing crystallization is preferred.

Expertise in trouble shooting chemical manufacturing for API

Familiarity with Regulatory strategy and execution

Six Sigma certification preferred

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.Who we are …Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.What we look for …In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .INVENT.IMPACT.INSPIRE.NOTICE FOR INTERNAL APPLICANTSIn 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.If you need an accommodation for the application process please email us at [email protected] more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprintposter.pdfEEOC GINA Supplement​ at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdfOFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdfOFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdfWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:NoTravel Requirements:25%Flexible Work Arrangements:Remote Work, TelecommutingShift:Not IndicatedValid Driving License:NoHazardous Material(s):noNumber of Openings:1Requisition ID: R19421

Vacancy caducado!

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