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Job: SR SPECIALIST, VALIDATION FOR NEW PRODUCT FEASIBILITY, Merck Sharpe & Dohme Corp, Durham, NC

General Information


Job title:
SR SPECIALIST, VALIDATION FOR NEW PRODUCT FEASIBILITY
Job location:
Durham, NC  27701 United States
Requisition code:
Date posted:
05/14/2019
Compensation:
Job category:
Engineering
Employment type:
Full time

Job Description


Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.


The Analytical & Technical Senior Specialist will be an energetic, technical contributor with strong interpersonal, communication, and collaboration skills responsible for assay troubleshooting and analytical assay validation for pipeline vaccine programs. This is 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, and Automation groups. Minimal supervision, guidance, and direction are employed by the supervisor; however, periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort.


Responsibilities may include but are not limited to;



  • Provide analytical support for pipeline vaccine products 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 projects 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, Change Management Group 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 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

  • Production of product that is safe and efficacious.


Qualifications


Education Minimum Requirement: 



  • Bachelor of Science Degree in Engineering or Life Sciences


Required Experience and Skills: 



  • Five (5) years of relevant experience; a Master of Science Degree with three (3) years of relevant experience; or a Ph.D. with relevant academic experience.

  • Experience in Analytical or Technical/Process Development

  • Experience in vaccine or biologics manufacturing within a cGMP environment

  • Experience authoring technical documentation within a cGMP context.

  • Proven technical communication (written & presentation) skills

  • Experience with project strategic plan development and management


Preferred Experience and Skills:



  • Hands-on expertise with vaccine release assays (Biological, Biochemical, Microbiological, and Chemical).

  • Technical knowledge and experience with cell culture, performing analytical assays, and troubleshooting assay issues

  • Experience with biological and biochemical assays

  • Experience with IVRP, protein quantification, DLS, SDS-HPSEC

  • Experience using data-mining software

  • Project management certification

  • Experience in new product introduction and method transfer

  • Ability to provide scientific mentorship and guidance to technical colleagues

  • Lean Six Sigma belt certification

  • Experience with Quality by Design (QbD)

  • Working understanding of process risk assessment tools

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


Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.


If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.


Search Firm Representatives Please Read Carefully: 


Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.


Visa sponsorship is not available for this position.


For more information about personal rights under Equal Employment Opportunity, visit:


EEOC Poster


EEOC GINA Supplement 


OFCCP EEO Supplement


Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.

Job Requirements


Please see complete job description above.
(Job number: 3839061)
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