Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.Durham’s Technology Transfer Senior Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process enhancement activities for pipeline vaccine programs.This position will primarily support the downstream purification process for the technology transfer of our HPV vaccine drug substance. Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Off-shift and weekend coverage will be required based on business unit needs and specific assignments.The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus.Responsibilities may include but are not limited to;
Provide technical/team support and leadership for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. buffers, media and cleaning solutions.
Actively participate on cross-functional manufacturing teams to advance project 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
Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related)
Collaborate with internal/external partners, e.g. Other sites, Procurement, Raw Material & Component Suppliers
Develop effective data analytics methodologies, including statistical process control, deepening process understanding
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
Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements
Provide post approval support and subject matter expertise support to ongoing manufacturing activities.
QualificationsEducation Minimum Requirement:
Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of five (5) years of relevant experience; a Master of Science Degree with a minimum of three (3) years of relevant experience; or a Ph.D. with relevant academic experience.
Required Experience and Skills:
Experience in vaccine or biologics manufacturing within a cGMP environment
Experience authoring technical documentation within a 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
Experience with Change Management, Deviation Management, and MES/Pas-X
Experience with Quality Risk Management Process
Experience with large scale buffer formulations and tangential flow filtration
Experience with technology transfer methodologies for introduction/launch of a cGMP product
Preferred Experience and Skills:
Experience in bulk upstream and/or downstream vaccine processes within a cGMP environment
Experience with Clean-in-Place and Sterilize-in-Place systems
Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions
Authored complex process change control
Authored complex deviation investigations
Experience with validation documentation and execution
Experience with SAP
Experience with Delta V
Experience with LIMS/GLIMS
Ability to provide scientific mentorship and guidance to technical colleagues
Ability to read Piping and Instrumentation Diagrams is desired
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
Advanced degree (MS, PhD) in science or engineering
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.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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/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 (https://survey.sogosurvey.com/r/aCdfqL) 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:EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.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 another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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 CarefullyMerck & 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:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aRequisition ID: R284126
