Director, Regulated Bioanalytics, Sample Management

Job DescriptionThe Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Department is seeking a Director to lead our Regulated Bioanalytics Sample Management group, which is based at our WP and Springhouse, PA sites, but also has oversight of related staff and processes in Germany. At these facilities, our sample management teams support the receipt and distribution of study samples and reagents for our Regulated Bioanalytics organization, which develops/validates/implements bioanalytical methods to generate pivotal study results for small molecule, biotherapeutic, and vaccine candidates in non-clinical through clinical phases of development.The individual will be responsible to lead all aspects of sample management operations across our West Point, PA, Springhouse, PA, and Schwabenheim, Germany facilities, while building strong relationships with clinical operations and other global staff to drive study improvements from clinical sites through the reporting of bioanalytical data. The individual will also support efforts to implement and enhance Laboratory Information Management Systems (LIMS) or other applications used by the team. The candidate should be current on state-of-the art technologies and is expected to champion evaluation of new technologies and optimize processes.  Representing the lab during quality and regulatory audits will be required.Education Minimum Requirement

B.A./B.S. in Biology, Molecular Biology, Chemistry, Biochemistry, Engineering, Biotechnology, or related discipline with at least 15 years, M.S. with at least 10 years, or Ph.D. with 8 years experience in a related field

Responsibilities

Manage the development, implementation, operation, and troubleshooting of automation solutions (e.g., sample stores, liquid handlers) within the sample management laboratory that addresses the receipt, aliquoting, and storage of regulated clinical samples and reagents

Recruit and develop a global sample management team and provide coaching and mentorship to grow talent to sustain our current and future pipeline

Develop and sustain strong relationships with clinical operations and drive process improvements that may occur starting at the clinical site, through the receipt, testing, and reporting of sample results

Lead staff through automated and manual sample receipt, processing, aliquoting, and distribution, ensuring efficiency and quality in sample management operations

Evaluate and validate new or updated applications (e.g., LIMS, automation systems) that enable improved sample management processes

Partner with IT on interfacing sample management automation data and systems into LIMS or other inventory management applications

Serve as an internal subject matter expert on new and existing automated liquid handler and automated samples store technology and capabilities

Author SOPs or job aids associated with sample management systems and processes

Perform responsibilities in compliance with departmental SOPs and regulatory guidances (e.g., GxP)

Serve as lab lead during internal or external regulatory audits

Develops priorities and objectives for the sample management team to align with division scorecard

Required Experience & Skills

Experience leading sample management staff within a GxP regulated lab

Experience working with lab automation, such as liquid handlers, robotics, or automated sample stores

Experience implementing and validating new or updated lab applications such as a laboratory information management systems (LIMS) or related systems

Strong verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators

Ability to communicate effectively in presentations to stakeholders in partner organizations, to write technical reports, and to participate on cross-functional teams 

Ability to build and maintain strong relationships with site leaders, corporate management, and other stakeholders to ensure effective communication of plans and issues

Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously

Ability to prioritize projects and resources to deliver required level of output and support

Ability to lead, mentor, and inspire team members at various levels; encourages curiosity in others and challenges the status quo to foster innovation

projectadvanCurrent Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.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.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:EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA Supplement​Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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.Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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 OrdinanceLos 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 OrdinanceSearch 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:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:12/27/2024A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Requisition ID: R327627