Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.
Our 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.
The Senior Specialist, Vaccine Technical Operations Analytical Lead will be an energetic, technical contributor with strong interpersonal, communication, and collaboration skills responsible for project management, shop floor assay transfer and qualification support, assay troubleshooting and developing the analytical strategy for inline vaccine programs at Durham. This position will primarily support vaccine drug substance site readiness and technology transfer.
The successful candidate must embrace and help to establish an empowered team culture, including significant interaction with Manufacturing, Quality, Automation, Process Support Laboratory, Global Engineering Solutions (GES) and a number of other global groups within the vaccine network. The successful candidate must be a self-starter with the capacity to understand the manufacturing process, analytical details, data integrity considerations, and equipment/instrumentation details. This role will be a member of the Technical Leadership Team and have responsibility in all process areas.
Provide analytical support for the drug substance vaccine process by bringing a technical background with a systematic problem-solving approach
Author technical reports and documents associated with site commercialization efforts (i.e. SOPs, CRs, investigations)
Provide technical/team support as required for analytical technology transfer, assay qualification, and assay validation
Determining the detailed specifications of lab equipment and participate in the equipment specification, selection/procurement, and qualification phases of a project
Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to the analytical process | Author technical documents to support regulatory filings including technical reports and risk assessments
Establishing a good working relationship with partners across the Merck network (Commercialization, Biologics & Vaccines Analytics and Merck Research Laboratories)
Works with the Technology, Automation, and Quality functions to determine the breadth and scope of investigations to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition
Supports all relevant quality and safety initiatives
Helps to establish empowered teams to achieve site mission, vision and goals through efficient and safe operation of process systems, compliance with current Good Manufacturing Practices and production of product that is safe and efficacious
Bachelor degree in Biology, Chemistry, Biochemistry, Engineering, or related engineering/science field with a minimum of five years of relevant experience; a Master of Science degree with a minimum of three years of relevant experience; or a Ph.D. with relevant academic experience
Experience and Skills
Analytical, Technical, or Process Development and Support
Vaccine or biologics manufacturing within a cGMP environment
Authoring technical documentation within a cGMP context
Proven technical communication (written & presentation) skills
Project strategic plan development and management
Direct expertise with vaccine release assays (Biological, Biochemical, Microbiological, and Chemical)
Technical knowledge and experience with cell culture, UPLC/HPLC, DLS, SoloVPE, Raman spectroscopy, Process mass spectrometers, and troubleshooting analytical methods
Project management certification
New product introduction and method transfer
Ability to provide scientific mentorship and guidance to technical colleagues
Lean Six Sigma belt certification
Data Integrity assessments
Working understanding of process risk assessment tools
In person presentation of technically complex subjects to regulatory inspectors
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 that's 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 …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In 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.
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Merck & 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.
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