Analytical & Strategic Improvements Lead

Job Description

Job Purpose:

• Lead strategic continuous improvement initiatives (e.g. Lab Transformation) across Quality, including Quality Control, Quality Operations, and Quality Assurance.

• Work closely with the Global Quality Leadership Team and Site Quality leaders, and Digital Manufacturing partners to define and deploy transformation and continuous improvements strategies to deliver key business outcomes in alignment with our company priorities.

• Lead the Analytical Procedure Lifecycle (APLC) program in accordance with USP <1220> and ICH Q14.

• Partner with Analytical Research and Development (ARD), Large Molecule Analytical Sciences (LMAS), Analytical Chemistry in Development and Supply (ACDS), Digital Manufacturing and Site Quality to ensure that methods are developed, validated, and transferred to QC in alignment with APLC expectations.

• Oversee the Procedure Performance Verification of analytical methods in QC ensuring methods continue to perform in line with expectations to support reliable, compliant supply from Quality Control.

Key Accountabilities:

• Collaborate with site quality leaders to understand their business challenges and create improvement plans to address gaps.

• Accountable to the Global Quality Leadership Team to ensure installation of foundational Manufacturing concepts aimed at delivering the most critical business outcomes.

• Coach and influence quality leaders in accordance with the operational excellence standards

• Facilitate governance and report progress against strategic milestones defined in the continuous improvement plans.

• Oversee the development of monitoring and improvement plans for key products and gain approval for these plans via APLC Steering Committee. Monitor completion of plan actions and update APLC Steering Committee as appropriate.

• Work seamlessly with partners across site Quality Control internally as well as with external partners to ensure standardized and continuous Procedure Performance Verification (PPV).

• Accountable for global standardization of APLC activities for analytical methods, building strong strategic partnerships across the Manufacturing and Research and Development divisions.

• Support ARD in the implementation and execution of the enhanced APLC approach to method development, validation, and transfer for new and inline methods.

• Lead the overall scientific technical and operational efforts for APLC implementation for products. 

Educational Requirements:

• Bachelor’s degree or Master’s degree in a technical discipline (e.g. biochemistry, chemistry, microbiology) with at least 15 years of experience or a PhD with 10 years of experience in industry, working directly with technology transfer and QC.

• 10+ years of analytical testing or development experience with assay validation expertise.

• 5+ years of experience leading a team in a regulated environment.

Desired Skills and Experiences:

• Experience with process improvements and application of Lean tools and techniques such as standardized work, scientific problem solving, value stream mapping, etc.

• Ability to recognize and mitigate barriers to cross-functional initiatives and act as an intermediary across divisional, geographical, and cultural boundaries.

• Ability to influence decision making, execute and coach on change management, and interact with all levels of the business (senior leaders to shop floor working teams).

• Strong emotional intelligence with a proven ability to build trust and develop new relationships to achieve successful outcomes at a local, regional, or global level.

• Experience enabling and leveraging diverse perspectives, experience, and talents to achieve business outcomes.

• Experience working in a GMP/regulated environment.

• Experience with Analytical Method Validation and relevant compendial guidelines, such as USP <1220>, ICH Q2/Q14, as well as analytical tech transfer.

• Expertise with late-stage regulatory submissions.

• Ability to manage multiple priorities and know when to escalate issues for resolution.

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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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