Quality Control Operations Laboratory Manager (R131676)

Job Description

Our Company is expanding its global vaccine production by adding a new laboratory within the Hilleman facility in Durham, NC. The new laboratory will be used to perform quality control testing for the specific vaccines. The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer activities to develop vaccines and future testing capability at the Durham site. The successful candidate will report to the Associate Director, Laboratory Operations to lead start-up of the new laboratory for microbiological, chemistry, and/or biologic based assays. Method transfer activities will include qualification of equipment, facility, and utilities.

Successful start-up of the laboratory will require candidates to work cross-functionally with existing Merck Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using principles of Merck Production Systems, Lean Laboratories, and GMP requirements.

Responsibilities

General

• Work cross-functionally with internal Merck sites and global partners to build testing capability within the Quality Laboratory Operations

• Collaborate with internal customers to ensure successful execution of method transfer or method validation activities

• Apply project management concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and budgeting

• Build knowledge of the company, processes and internal/external customers

• Build and maintain strong relationships with site leadership, stakeholders, and customers

• Build relationships to work in a highly functioning diverse team environment

• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals

• Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing

• Capability to function effectively within an automated/electronic laboratory environment

• Utilizes performance metrics and lean six sigma tools to drive continual improvement and efficiencies

Business Expertise

• Understands the fundamental business drivers for the company; uses this knowledge in own work and applies regulatory/compliance requirements relative to their role

• Influence, motivate, and energize individuals at all levels in the organization

Functional Expertise

The Laboratory Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation activities and routine product testing to include the following:

• Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods

• Trouble-shoot laboratory process and equipment issues

• Sample management

• Planning and test method execution to meet established delivery timelines

• Provide active support during audits and inspections (regulatory, internal, safety)

• Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations

• Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements

• Influence, motivate, and energize individuals at all levels in the organization

• Support the Manufacturing Division Divisional and Quality initiatives

• Additional project and routine testing support as required by laboratory testing requirements

• Other duties as requested by management to support effective laboratory operations and performance metrics

Problem Solving and Impact

• Identifies and solves a range of problems in both straightforward and undefined situations; analyzes possible solutions and assesses each using standard procedures

• Errors on the job may cause time delays and impact the work of others in own work group or potentially impact product disposition

• Influence and Decision Making

• Represents Quality in the laboratory to influence cGMP compliance and ensure product quality

• Explains information and persuades others in straightforward and low complexity situations as a subject matter expert

• Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines

• Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality

Internal | External Client and Customer Focus

• Responds to standard requests from internal and external customers

Project and Resource Management

• Accountable for quality and/or technical contribution to project team or sub-team.

• Lead project team initiatives to ensure timelines are met and laboratories are prepared for routine product testing

• Aware of costs and assists in controlling costs related to own work

Education Requirements

• Bachelor or Master of Science degree in Biological Sciences

Experience and Skills

Required

• A minimum of five (5) years of laboratory experience

• Implementation and trouble-shooting of microbiological, chemistry, and biologic assays

• Aseptic handling techniques

• Technical writing skills

• GMP laboratory

Preferred

• Leadership

• Direct expertise with executing and trouble-shooting with microbiological, chemistry and biologic assays

• New assay development, validation, and/or technology transfer

• Authoring technical documents supporting regulatory filings (FDA, EMA, JNDA)

• Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry

• Biological assay testing in microbiology, virology, and chemistry

• Regulatory agency audits and/or regulatory filings

• Lean Six-sigma and problem-solving tools

Physical Requirements

• Ability to sit, stand and move within work space for extended periods

• Ability to work standing in a laboratory environment for extended periods

• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling

Working Relationships

• Reports to Associate Director, Laboratory Operations

• Represents analytical laboratory in cross functional project meetings

• Interacts with employees within own department

• Frequent interaction with employees from other departments and across Merck sites

• Interacts with Representatives from regulatory agencies | External suppliers

Travel

• Travel to sites in Virginia and Pennsylvania for training and assay development

#BCGExp

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.

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Requisition ID:R131676