Job Description

Are you passionate about transforming scientific innovation into life-saving therapies? Join our dynamic team, where you'll play a pivotal role in advancing large molecule and biologics commercialization.

Together, we'll set new standards in quality and safety while making a tangible impact on global health! Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Global Quality Large Molecule Analytical Sciences, in our Manufacturing Division, is accountable for the commercialization of large molecule, vaccines and biologics, analytical techniques from Phase III through launch and transfer to supply. This team is highly motivated, fast-paced and focused on the rapid advancement of our Company's large molecule pipeline, plus growth of existing products. This position will involve oversight of late-stage method development, validation, and life-cycle management of methods but mainly global method transfer activities.

Within the Global Quality Large Molecule Analytical Sciences organization, this Analytical Transfer Team include activities interfacing with a global network of product manufacturing and testing sites, collaborating with product development groups within our manufacturing division and our Research Laboratories division, continuous improvement of analytical methodology, assay validation, analytical technical transfer, and Biologics License Application preparation.

Position Responsibilities

• Lead method transfers and/or validations across vaccine and biologics programs including gap analysis.

• Provide sponsorship of both in-line and pipeline analytical methods. The candidate will interface across our Company network and external partners to ensure the successful commercialization of assays promoting our pipeline programs

• Involvement in development, troubleshooting and optimization of analytical methods

• Continuous improvement using laboratory standardization, lean laboratory, and six sigma methodology

• Analytical Procedure Life Cycle activities across various large molecule franchises and analytical platforms

• Promote various vaccine and/or biologics registrations, launches, and troubleshooting activities external to the US, including documentation preparation

• Direct strategic initiatives within departmental and cross-functional teams representing Global Quality Large Molecule Analytical Sciences.

• Manage global registration and test on importation activities

• Collaborating with commercial manufacturing teams to support facility start-up activities, New Product Introduction and provide analytical support both within our Company network and at contract manufacturing organizations or contract testing laboratories

Education and Experience Requirement

• Bachelor's degree, Master's degree or PhD in biology, chemistry, biochemistry, or related science

• Six (6) years of relevant industry knowledge in systematic development, validation, and/or quality control

Required Knowledge | Skills

• Knowledge of ICH, USP and other compendial chapters required for method transfer and validation.

• Knowledge with late-stage method development, validation, and transfer

• Minimum two years working knowledge in a current Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics)

• Development and management of project timelines and deliverables

• Participation in cross-functional project teams

• Authoring and review of technical documents

• Ability to work objectively and within a cross-functional team

• Technical, verbal, and written communications, stakeholder management, and teamwork skills

• Self-motivated with a positive attitude and proven performance record

• Knowledge with drug substance and drug product release, stability, and extended characterization testing for vaccines and biologics

• Strong organizational and project management skills

• Ability to effectively identify and express risks

• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ)

Preferred Experience and Skills

• Deviation management and change control processes

• Global launch or supply experiences

• Supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA)

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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.

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U.S. Hybrid Work Model

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".

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
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:R332229