Job Description

GENERAL SUMMARY:

Our company is expanding its global Bacillus Calmette Guerin (BCG) vaccine production by adding an end-to-end laboratory capability located in the Durham, NC campus. The new facility will be used to produce the bulk active ingredient, finished product, and laboratory testing for the BCG vaccine.

The Senior Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing of the BCG Product. Initially the position will focus on microbiology and sterility testing readiness in preparation for commercial production. The selected candidate will initially work on assay development, assay validation, equipment validation, and GMP laboratory readiness. The Senior Specialist, Quality Control will be responsible for starting testing in new laboratories using principles of our Production Systems, Lean Laboratories, and GMP requirements. At the completion of assay development and qualification, the Senior Specialist, Quality Control will execute routine testing of new and or existing products, continuing process improvements, troubleshooting, writing SOPs, and investigational testing support. The selected candidate will support the sterility and microbiology testing laboratories with emphasis on microbiological methods (such as microbial enumeration, bacterial endotoxin, sterility). The analyst will also be expected to review and authorize testing results, collaborate in day-to-day lab scheduling, provide leadership in lean lab initiatives, have a strong understand of Labware LIMS, handle Quality Notification authoring and provide audit support.

GENERAL PROFILE:

• Collaborate with internal customers and vendors to identify, evaluate, and implement new analytical technologies that expand site capabilities. Apply project management concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/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

• This position will be located at the Durham, NC site. Short periods of travel may be required as needed for training.

BUSINESS EXPERTISE:

• Understands the fundamental business drivers for the company; uses this knowledge in own work

• Understands and applies regulatory/ compliance requirements relative to their role

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

FUNCTIONAL EXPERTISE:

The Senior Specialist, Quality Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to include the following:

• Lead for microbiology and sterility assay qualification, including but not limited to microbial enumeration testing, endotoxin, rapid microbiology methods, compendial sterility testing and non-compendial sterility testing.

• Microbiology and sterility routine testing, including but not limited to microbial limits, endotoxin, rapid microbiology methods, compendial sterility testing and non-compendial sterility testing.

• Schedule daily testing of laboratory samples based on internal metrics and production needs.

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

• Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions

• Execute test method qualification

• Trouble-shoot method and equipment issues as needed

• Sample management

• Planning and test method execution to meet established delivery timelines

• Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning

• Train and mentor laboratory analysts on test methods, techniques, and good documentation practices.

• Review of laboratory generated data and results

• Has knowledge of cell culture propagation and maintenance procedures, and/or microbiological laboratory procedures

• 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 Divisional and Quality initiatives.

• Additional project and routine testing support as required by vaccine analytical testing requirements

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

PROBLEM SOLVING:

• Identifies and solves a range of problems in straight forward situations; analyzes possible solutions and assesses each using standard procedures

INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:

• Responds to standard requests from internal and external customers

IMPACT:

• 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 situations

• 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

PROJECT MANAGEMENT:

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

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

RESOURCE MANAGEMENT:

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

QUALIFICATIONS:

Required

• B.S. or M.S. degree in Biological Sciences, with minimum of 5 years of laboratory experience

• Experience with aseptic manipulations

• Exceptional pipetting techniques

• Good technical writing skills and high attention to detail.

• Experience with execution and trouble-shooting of cell based and other microbiological/biological assays.

• Previous GMP-laboratory experience

• Work independently and within a team environment

• Sterility testing (compendia or rapid microbiological methods) experience

• Experience with compendial microbiological testing such as (USP Chapters <61>, <62>, and <85>)

• Experience with assay development, validation, or technical transfers

Preferred:

• Experience with responding to regulatory questions with multiple agencies (FDA, EMA, JNDA,).

• Equipment Validation

• Root cause analysis methodology

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

• Experience in regulatory agency audits and/or regulatory filings

• Experience in technical writing, including Standard Operating Procedures and method transfer/qualification reports

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

• Ability to travel

WORKING RELATIONSHIPS:

• Reports to Microbiology Manager

• Interacts with employees within own department

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

• Interacts with representatives from regulatory agencies

• Interacts with external suppliers

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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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Relocation:

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Requisition ID:R322564