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Company Name:
Approximate Salary:
USD 
Location:
Rahway, New Jersey
Country:
United States
Job Categories:
IH Manager/Coordinator: Single site
IH Manager/Coordinator: Multi-site
Industry Segments:
Pharmaceuticals
Experience level:
6-10 years
Education level:
Doctorate Degree
Reference Number:
R12646

Industrial Hygiene Laboratory Manager

Job Description

The Industrial Hygiene Laboratory (IHL) Manager & Quality Control Coordinator position will lead and drive technical and quality functions of operating an American Industrial Hygiene Association (AIHA) Accredited laboratory. 

  • Through the IH Lab staff and approved external IH laboratory partners, are responsible for developing methods, analyzing samples and reporting.  Maintains accreditation status of the our Company's IH Laboratory with the American Industrial Hygiene Association, develops methods, participates in inter-laboratory testing programs, adheres to recognized standards of quality control and remains prepared to defend results if legally challenged.
  • Expert knowledge, proven leadership abilities and experience in lab management, program development and execution within pharmaceutical and biopharmaceutical industries.  As a leading technical expert in industrial hygiene method development and analysis, must be able to lead, influence, collaborate and communicate with all levels of organization.  Proven ability to solve problems efficiently and effectively.
  • Responsible for industrial hygiene sampling and analysis method development and validation using HPLC, UPLC, LC/MS/MS and ELISA.  Executes documented method development/validation protocols to support new sampling and analysis method activities.  Ability to work independently using sophisticated laboratory instrumentation and computer systems.
  • The successful candidate will need to collaborate with global colleagues to ensure proper sampling methods, analyses and quality programs are maintained.  The IH Lab Manager must be able to drive prioritization and management of IH method development and sample analyses, ensure regulatory compliance, maintain AIHA accreditation (ISO 17025 compliance) and prioritize continuous performance improvement efforts.

 

Major Activities and Responsibilities:

  • Lead program and develop industrial hygiene sampling and analysis methods and validate using HPLC, UPLC, LC/MS/MS and ELISA
  • Technically review all industrial hygiene sampling results, create reports and communicate results to sites.
  • Conduct annual reviews of Quality Manual and Chemical Hygiene Plan
  • Act as system administrator for Laboratory Information Management System (LIMS) and internal Company IH database SHEMIS; works with approved external laboratories to enable uploading of analytical data.
  • Administers technical aspects of operating the Laboratory including establishing the policies under which the Laboratory will operate and the detailed procedures for receiving, assigning, analyzing, recording, and reporting results pertaining to samples submitted by health professionals worldwide
  • Decides and publishes the most appropriate IH sampling and analytical methods (air & wipe) to evaluate potential workplace exposures / surface contamination and advises the clients.
  • Works with IH Team and IH Coordinators to prioritize and develop appropriate IH air and wipe sampling methods, validates the analytical methods and is accountable for the accuracy and precision of each.
  • Is the final signatory to all Certificates of Analysis performed by the IH Lab
  • Oversees the analyses by approved external IH laboratories
  • Provides technical guidance to Laboratory staff members, provides training and resolves problems. 
  • Manages a system of communications with clients on sampling errors and unanticipated results; when necessary, notifies clients of unusual results immediately and provides interpretation.
  • Maintains a database management system so that (a) all data retrievable in sorted format (b) laboratory performances can be monitored and analyzed, and (c) site data can be transferred electronically to health professionals as needed.
  • Establishes a program for quality control of the methods, equipment and lab staff.  Participates in voluntary inter-laboratory testing programs and submits to the proficiency testing program for Accreditation by the American Industrial Hygiene Association.
  • Remains current in the field by reviewing the literature, participating in professional organizations and where appropriate, contributes to the profession by publishing articles or making presentations.
  • As requested, represents the Company on external panels, committees and advisory groups and if necessary, provides depositions or testimony regarding any litigation supportable by the work of the Laboratory.
  • Remain current in the method development and analytical techniques for potent small molecules and large molecules practice of industrial hygiene, have current knowledge of regulatory requirements and recognized pharmaceutical industry IH practices and controls. Participate in professional organizations, on outside panels, committees and advisory groups as appropriate. 

Required:

  • Ph.D. and 5 years of experience, or MS and 10 years of experience in Analytical Chemistry or related discipline.
  • Hands-on laboratory experience with HPLC/UPLC and LC/MS/MS
  • Direct experience in developing analytical techniques and understanding equipment for pharmaceutical method development and analyses including HPLC/UPLC and LC/MS/MS
  • Minimum of 3 years of laboratory management experience
  • Experience using Laboratory Information Management System (LIMS) and Empower instrument management software (or similar)
  • Excellent written and verbal communication skills
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Access)
  • Working knowledge of laboratory regulatory requirements, industry consensus standards, and recognized best practices
  • Demonstrate attributes consistent with the Our Company's workforce of the future; adaptability, flexibility, teamwork, accountability and innovation
  • Formal course in statistics (documentation via transcript or certificate required)

 

Preferred:

  • Experience in pharmaceutical or life sciences industry within a production-oriented laboratory
  • Experience using Immunoassay technology (ELISA, MARIA) to test samples and develop analysis methods
  • Certification by the American Board of Industrial Hygiene
  • Experience in running an ISO-17025 certified lab
  • Proficiency in other Microsoft applications - SharePoint, Teams
  • Experience managing databases

 

Our Support Functions deliver services and makes recommendations about ways to enhance our workplace and the experience of working at our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security. 

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.