Vacancy expired!
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.We currently have an exciting opportunity for an experienced product development Scientist/Engineer to join Sterile Liquid Commercialization (SLC) supporting sterile/liquid process development. The group is based out of West Point, PA.SLC is responsible for product development, process scale-up, registration support, and launch support for our Company’s sterile drug products. SLC develops formulation and filling processes for sterile pharmaceuticals, vaccines, and biologics programs starting at Phase II and extending through initial years of product launch. SLC also supports life cycle management opportunities and significant process improvements for in-line sterile products.The person in this role will have the opportunity to:
Perform product and process development studies for sterile/liquid products.
Author experimental protocols and reports
Participate on project teams and working groups.
Develop robust and scalable manufacturing processes while minimizing time to product launch.
Implement process improvements to reduce product cost structure.
Participate in transfer of processes to commercial supply sites
Support execution of validation lots and contribute to regulatory filing documentation.
Evaluate new technologies related to pharmaceutical processing
Education Minimum Requirement:
Bachelor's degree in Pharmaceutics, Chemical Engineering or related-field with a minimum of 2 years of relevant experience; or Master's degree (non-thesis) with a minimum of 1 year of relevant experience; or Master's degree (with thesis) with less than 1 year of relevant experience
Required Experience and Skills:
Relevant experience commensurate with education level, as listed above
Preferred Experience and Skills:
Experience with product/product characterization, e.g. DSC, HPLC, etc.
Experience operating or managing analytical lab activities, including creation of standard procedures, etc.
Knowledge of cGMP and typical unit operations for the manufacture of sterile dosage forms.
Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale
Experience in process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
Experience in Design of Experiment (DoE) and statistical data analysis.
Competency in technical writing.
Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
Analytical problem solving skills
Experience in Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing)
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.US and Puerto Rico Residents OnlyIf you need an accommodation for the application process please email us at staffingaadar@merck.comFor 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:10%Flexible Work Arrangements:Not SpecifiedShift:Not IndicatedValid Driving License:Hazardous Material(s):Number of Openings:2Requisition ID: R57214
