Associate Director, Lyophilization Steward

Company: Merck
Location: Charleston
Posted on: May 3, 2021

Job Description:

Job DescriptionA Lyophilization Steward is the designated expert in Lyophilization process technology and will provide end-to-end support of manufacturing science and technology for both commercial products and pipeline vaccines with a global scope. The position resides within the Bio-Technology Solutions (BTS) Product and Platform Steward group and supports existing and manufacturing operations within our Company's Manufacturing Division. This incumbent is expected to serve as a leading scientific expert providing guidance, recommendations and judgment for strategic technical issues and decisions pertaining to Lyophilization process technology within large molecule Global Animal Health Manufacturing (GAHM). This position will not have employee management responsibilities.Primary Responsibilities+ Serve as the subject matter expert for Lyophilization process technology throughout the GAHM organization. + Collaborate as needed with research, process development, and internal/external manufacturing sites to support New Product Introductions, enabling on-time, right-first-time technology transfers. + Serve as the single point of technical governance to the Research & Development, Value Chain/Supply Chain Management, Manufacturing Operations and Commercial/Marketing groups to manage all technical aspects pertaining to Lyophilization process technology. + Build and maintain strong and trusting relationships with R&D Species Leaders, Value Chain Leaders, site leaders, functional management, and other stakeholders to ensure effective communication of plans and issues. + Stay abreast of scientific developments and trends in Lyophilization process technology and participate in external industry/regulatory forums in order to maintain an industry-leading level of subject proficiency. + Provide technical/scientific guidance and oversight to project teams that are doing process changes, process improvements or technology transfers involving Lyophilization process technology. + Provide technical/scientific guidance to major investigations related to Lyophilization, for example, investigations related to yield declines or stability trends + Establish company best practices and standards where appropriate as related to Lyophilization process technology. + Develop recommendations and options for Lyophilization process improvements.Education Minimum Requirements+ Bachelor's degree in a technical or scientific discipline such as Biology, Chemistry or Engineering + Preferred: PhD or advanced degree with specialization in a subject pertinent to vaccine/large molecule manufactureRequired Experience and Skills+ At least seven years of relevant work experience in the pharmaceutical, biotech, or related industry + Commercial processes experience for vaccines/large molecules/small molecules is required, either in development or in technical support + Demonstrated problem solving, effective verbal and written communication + Strong scientific understanding of vaccine and/or biologic products and/or small molecule processes and their effective integration with relevant regulatory/GMP requirements + Ability to collaborate effectively, across functional boundaries, to align stakeholders and sponsors on technical strategies + Proficiency with pharmaceutical industry technical business processes, i.e. change control, deviation management, technical protocols/reports, and regulatory license documents Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted to delivering a high quality, reliable supply to customers and patients on time, every time.Who we are We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.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 continueInventing For Life, Impacting LiveswhileInspiring 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.Residents of ColoradoClick here (/r/O2fDro) to request this roles pay range. Current Employees apply HERE (/msd/d/inst/1422$1533/rel-task/3001$14.htmld) Current Contingent Workers apply HERE (/msd/d/task/1422$4020.htmld)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 (/r/aCdfqL []) if you need an accommodation during the application or hiring process. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster (ol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf) EEOC GINA Supplement? OFCCP EEO Supplement (ol.gov/ofccp/regs/compliance/posters/pdf/OFCCP/_EEO/_Supplement/_Final/_JRF/_QA/_508c.pdf) 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 anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.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:Flex Time, Remote Work, TelecommutingShift:1st - DayValid Driving License:YesHazardous Material(s):Number of Openings:1Requisition ID:R111758

Keywords: Merck, Charleston , Associate Director, Lyophilization Steward, Other , Charleston, West Virginia