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Job Description Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The Executive Director of Analytical Procedure Lifecycle (APLC) will be responsible for the continuous assay lifecycle of critical large molecule inline analytical methods in accordance with USP <1220> .The Analytical Procedure Lifecycle and ICH Q2 Validation of Analytical Procedures: Text and Methodology. This includes conceptualizing how APLC will be strategically implemented across Quality Control over time, while immediately standing-up a targeted APLC program that ensures routine monitoring, analytical control strategy, knowledge management and change control for the most critical analytical methods. The candidate will work seamlessly with partners across large molecule Quality Control, both internally and with external partners, to ensure standardized and continuous procedure performance verification, gap analysis and remediation. To that end, this person will work with Quality Leadership and experts in the analytical community to identify gaps to existing analytical methods, highlight issues in a systematic way and remediate gaps to ensure all methods remain in a state of cGMP compliance. The candidate will be responsible for leading a team of analytical subject matter experts and scientists who will be accountable for the technical assessments of analytical methods, gap analysis, coordination of testing and completion of the work needed to enable remediation. Most importantly, the candidate will be tasked with global standardization of APLC for vaccines and biologics, and thus must be a transformational leader with the ability to build strong and strategic partnerships across the Manufacturing division globally and across the enterprise with Research & Development (R&D). The team will contribute or lead health authority inquiries regarding analytical method performance, as well as provide leadership and subject matter expertise for investigations, change control and CAPA plans and effectiveness.The Executive Director reports directly to the Associate Vice President, Quality Control and will be responsible for managing an indirect multidisciplinary team of project managers and scientists, starting with a small team focused on building the APLC program over 12-24 months’ time across our company working with all local sites, global QC and AR&D (R&D). As the QMS and implementation of APLC rolls out, the leader will build the right-sized workforce to support the program by capitalizing on the existing framework in QC such that the APLC program is built to serve the needs of each site QC while being predictive of continuous performance monitoring. This position will partner very closely with the Assay Monitoring Strategy Lead and TEL in order to strategize and streamline the modernization of QC laboratory operations. The Executive Director manages the work across QC to ensure that the goals of the project team is met in a timely, cost-sensitive, and compliant manner. They would be accountable for the growth/career development and performance of any direct reports with a demonstrated ability to collaborate, build high-performing teams, develop diverse talent, set and achieve a strategic direction for the team and implement and manage change to enable process improvement and optimal workflows.Responsibilities include, but are not limited to, the following:Scientific Excellence & Innovation : Responsible for leading the overall scientific, technical and operational efforts of APLC implementation for our company. The lead will also work closely with the Assay Monitoring Strategy Lead and TEL to build a cohesive deployment strategy for APLC. Quality and Regulatory Standards : Develops, maintains and implements quality standards for APLC. Addresses quality-related inquiries from regulatory agencies and assists in managing significant QNs related to analytical robustness.Compliance Systems : Sets a high compliance standard and ensures that systems and resources are in place to conduct the activities in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, and OSHA safety standards and in accordance with corporate requirements. Partners with colleagues to ensure overall laboratory readiness for regulatory inspections and internal audits.Project Management and Teamwork : Responsible for managing quality and timelines for key APLC assessment activities supporting analytical projects and bringing analytical representation and expertise to CMC, project teams and task forces as appropriate. Facilitates teamwork and coordinates execution of plans with key stakeholders. Allocates resources or works with department leadership to install resources and ensures tracking and follow-up as necessary. Ensures the department works as a partner with collaborators and teams.Building Teams & Talent : Responsible for setting high standards, building and managing a high performing team. Sets department goals and performance objectives, supports talent development and proactively addresses performance issues. Identifies department needs and recruits/hires/promotes talent as appropriate to grow and progress the organization. Allocates proper resources for meeting goals and objectives. Communications : Maintains productive communications with staff, colleagues across QC and commercialization, Quality Assurance, Technical Operations, and CMC Regulatory Affairs as needed to ensure understanding of needs, proper prioritization and timely delivery of product knowledge, customer-oriented data and documentation. Regularly exchanges ideas and information to develop effective plans and strategies to meet business needs.Education: Bachelor's or Master’s Degree with at least 15 years of industry experience; OR a PhD with 10 years of industry experience, working directly in the field of analytical development, testing and/or tech transfer.
Required: 10 + years of analytical testing or development experience with assay validation expertise
5 + years of experience leading a team in a regulated, Quality laboratory environment.
Demonstrated experience in participating in regulatory inspections as a subject matter expert
Demonstrated ability in leading large analytical teams and mentoring and developing talent.
Incumbent must have excellent interpersonal, communication, and collaboration skills.
Strength in delivering results on firm deadlines in support of drug/vaccine development and commercialization
Must have a strong Quality background with demonstrated, direct experience defending content during health authority inspections, writing/reviewing regulatory technical questions
Ability to lead teams demonstrated through 3 key levers:
Experience as a direct manager of a platform, including people (day-to-day work, EDP, performance management), financial budget and department resources.
Experience as a cross-functional leader with the ability to drive right first-time execution of projects/testing, while maintaining strong relationships and collaborative mindset.
Demonstrated examples of driving change across the global environment in a positive way. Having previous experience with cross-functional, transformational efforts is highly desired.
Demonstrated experience with Analytical Method Validation and relevant compendial guidelines, such as ICH Q2/Q14, as well as analytical tech transfer.
Preferred: Experience with late-stage regulatory submissions
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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., Rahway, 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.NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company. Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) 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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf) EEOC GINA Supplement OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf) Pay Transparency Nondiscrimination 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Residents of Colorado: Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range. Search Firm Representatives Please Read CarefullyMerck & 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. Employee Status: RegularRelocation: DomesticVISA Sponsorship: NoTravel Requirements: 25%Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1Requisition ID: R204710
Vacancy expired!