Associate Director - Sample Management Lead

Job Description

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, subject to applicable law.

The Company's Regulated Bioanalytics (BA) group in West Point, PA and Kenilworth, NJ supports regulated bioanalytical assay development and validation, and testing for the development of small molecule, vaccines and biotherapeutics. We are seeking a highly talented and motivated individual to lead the Sample Management Team responsible for the lifecycle of nonclinical and clinical study specimens and critical reagents. The candidate will oversee the day to day activities of nonclinical and clinical sample receipt and distribution while driving innovative and strategic projects that will automate and improve processes (e.g. automated biostores and/or liquid handlers, improve data flow and documentation, LIMS enhancements, etc.). The candidate will directly manage a team that operate across the bioanalytical labs and help to mentor and drive career development for the staff in this team. As a leader within the organization, this individual will be a key collaborator across the various BA, GLP, and clinical teams as we partner to support critical therapeutic and vaccine candidates and make improvements in related study processes.

Responsibilities:
  • Lead a small team of sample managers across two GLP regulated bioanalytical labs and maintain the chain of custody of all incoming and outgoing nonclinical and clinical samples and critical reagents.
  • Develop and implement innovative improvements to automate sample receipt and tracking, sample/reagent aliquoting, and drive process changes that improve the overall sample workflow.
  • Demonstrate inspirational leadership; supporting staff development through mentorship and training, while working with staff side by side on both innovative and routine projects.
  • Monitor and track key metrics for the lab, partnering with IT or related staff for the creation of dashboards to generate automated/real-time displays of sample receipt and testing progress.
  • Collaborate with study personnel to coordinate sample and reagent shipments, resolve sample discrepancies, and handle logistics of international import/exports.
  • Build key partnerships with external long-term sample storage facilities and help to manage the movement of samples and reagents across on-site and off-site locations.
  • Develop expertise in the use of our company's Laboratory Information Management Systems (LIMS) to setup studies, maintain sample chain of custody records, facilitate data reconciliation, and partner with IT and BA staff to develop ongoing system improvements.
  • Manage sample freezers, including the handling of temperature alarms and oversight of monitoring system/software.
  • Represent the laboratory during audit as the sample management lead
  • Responsible for authorship of sample management related SOPs, job aids, and electronic notebook documentation templates.
  • Position will require travel between West Point, PA and Kenilworth, NJ sites through 4Q2022, after which sample management teams will be consolidated in Pennsylvania.


Position Qualifications :

Education Minimum Requirement:
  • B.S. Degree in Biology, Chemistry, Engineering, or related sciences with at least 8 years of industry experience or an M.S. with 6 years of related experience.


Required Experience and Skills:
  • Experience working within a GLP or GMP laboratory, preferably in a bioanalytical lab
  • Experience managing the chain of custody of study samples from receipt to destruction/off-site shipment
  • Experience with the use of Laboratory Information Management Systems (e.g. Watson, Labware, etc.) for the management of samples and/or reagents
  • Experience with the use or implementation of laboratory automation (liquid handlers, biostores, etc.)
  • Prior experience supervising and training laboratory staff
  • Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators
  • Capable of working independently, and overseeing operations of at least 2 distinct lab locations
  • Innovative thinker, with a track record of driving process improvement


We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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.

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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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
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.

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:

Shift:
1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R144035