02 May
Senior Specialist, Analytical Technology
North Carolina, Durham

Job DescriptionOur Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.Position Description:The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company’s lifesaving vaccines.Our Technical Operations team in Durham is seeking a Senior Specialist to join our team to support vaccine analytical site readiness and technology transfer. The Senior Specialist is responsible for implementation of analytical transfer process knowledge, post approval support and post commercial assay enhancement activities for pipeline vaccine programs. To be successful in the Analytical Transfer Senior Specialist role, you will need to be an energetic, technical leader with strong interpersonal, communication, and collaboration skills.Responsibilities may include but are not limited to;

Provide technical/team support and leadership for commercial analytical transfer, and qualification studies associated with the development and implementation of assays for product release

Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process

Lead technical studies and author documentation associated with site commercialization efforts

Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects

Collaborate with internal customers and vendors to identify, evaluate, and implement new process and analytical technologies that expand site capabilities.

Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments

Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines.

Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls

Provide post approval support and subject matter expertise support to ongoing quality laboratory release activities.

Position Qualifications:Required Education, Experience and Skills:

Bachelor of Science Degree in Biochemistry, Biology, Chemistry, Bio-engineering, or related life science field AND a minimum of five (5) years of relevant experience OR

A Master of Science Degree with a minimum of three (3) years of relevant experience OR

A Ph.D. with relevant academic experience.

Experience developing analytical comparability protocols and reports

Experience in a laboratory within a current Good Manufacturing Practices (cGMP) environment

Experience authoring technical documentation within a current Good Manufacturing Practices (cGMP) context

Proven leader with influence and outstanding communication (written & presentation) skills

Experience with project strategic plan development and management

Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development

Preferred Experience and Skills:

Experience with drug substance and drug product release, stability and extended characterization testing for vaccines and biologics

Experience with analytical transfer methodologies for introduction/launch of a current Good Manufacturing Practices (cGMP) product

Experience with raw material and stability testing

Authored complex process change control

Authored complex deviation investigations

Experience with validation documentation and execution

Ability to provide scientific mentorship and guidance to technical colleagues

Ability to read Piping and Instrumentation Diagrams

Lean Six Sigma belt certification

Experience with process risk assessment tools

Experience with responding to regulatory questions with multiple agencies (e.g.FDA, EMA)

Experience with face to face presentation of technically complex subjects to regulatory inspectors

Experience or training in project management

Travel : 10% of the timeOur 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 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:Shift:1st - DayValid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R51805


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