**Job Description** We are seeking a highly motivated individual for the role of Associate Director, Biologics Down Stream Process Lead within the Enterprise Go To Market (EGTM) team, part of the larger Biologics Large Molecule Science and Technology (LMS&T) team. This role will serve as a scientific and technical resource for downstream operations (e.g. chromatography, tangential flow filtration, etc.), lead investigations and provide guidance and training to operations staff. The incumbent will demonstrate deep expertise for people management leadership and product/process sciences and engineering. The incumbent will have broad, experience-based skillsets in technology transfers of downstream operations. The incumbent must focus on standards and right first-time success for PPQ of commercial scale manufacturing processes. In addition, the incumbent will adhere to applicable business processes including program/portfolio management tools while working with internal and external manufacturing partners and influencing technical strategy. The incumbent will partner with groups across our Company and that includes the Global Human Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory-CMC, and Supply Chain. The end-to-end scope includes Drug Substance for all large molecules. The Associate Director is expected to contribute to ongoing business process improvements and all Tech Transfer activities. **Key Responsibilities:** + Leading Downstream processing (DSP) Technical Transfer (TT) activities ensuring On-time Delivery: Manages and accountable for the overall DSP technology transfer activities with end-to-end visibility on sending and receiving site deliverables for DSP operations readiness. Manages and leads collaboration for TT related regulatory authoring and filing activities. + Accountable to ensure the DSP TT project deliverables (metrics) are met and are on time. Includes regulatory filing of related sections and regulatory approval of the TT node. + Working with the TT Lead and matrix team members, accountable for detailed TT planning, TT schedules, gap assessments, risk assessments and mitigations, knowledge and data plans for that TT, stage gate readiness and reviews, supporting sending and receiving unit deliverables, authoring facility fit assessment and validation strategy documents, reviewing various sending (control strategy, comparability strategy etc.), and receiving site documents (validation protocols, Batch Reports, campaign summary reports, PPQ reports, investigation reports etc.), authoring BLA/MAA sections. + Supports Person In Plant (PIP) activities. + Manages TT Technical Issues and escalations. Works under and with program leadership teams for program escalations and works with New Product Introduction/Operations lead for business unit operations escalations. + Ensures TT standards and workflows are applied during TT. + Supports After Action Reviews and knowledge sharing with other TT teams. + Required to comply with our Company Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. + Work collaboratively to drive a safe and compliant culture. + Leads cross-functional, matrixed tech transfer team focused on Large Molecule TT of DSP processes to achieve right first-time PPQ validation with line-of-sight to filing and licensure. + Builds strong cross-divisional partnerships with site leaders, functional management, and other stakeholders (Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical Regulatory-CMC, and Supply Chain, etc.) + Contributes to presentations at stage gates and other TT local governance meetings. + Aligns program and site goals to execute the TT. **Minimum Education Requirements and Experience** + Bachelor of Science (B.S.) in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of seven (7) years of experience in Downstream Processing (DSP) Operations, technical proficiency in downstream biologics processing, and compliance with cGMP and global standards for biologics. **OR** + Master of Science (M.S.) in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of five (5) years of experience in Downstream Processing (DSP) Operations, technical proficiency in downstream biologics processing, and compliance with cGMP and global standards for biologics. **OR** + Ph.D. degree in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of three (3) years of experience in Downstream Processing (DSP) Operations, technical proficiency in downstream biologics processing, and compliance with cGMP and global standards for biologics. **Required Skills and Experience:** + Manages effectively with diverse teams (cross-functionally, cross-culturally, and across internal / external sites) to align and drive TT results. + Viewed as an expert in DSP operations. + Effective verbal and written communicator who keeps stakeholders / partners apprised of plans, status, and issues. + Works well in ambiguity. + Able to articulate TT to others. + Establishes clear goals, delegates effectively, holds self and others accountable. + Flexible and adaptable to dynamic situations + Cross-functional team management; successful at indirect management. + Ability to succeed in a dynamic environment with flexibility to respond to changing priorities. + Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas. + Well-developed and effective team facilitation and leadership skills; ability to establish inclusive team environments. + Expertise in technical aspects of product commercialization and life cycle management + Strong scientific knowledge of multiple TT types including vaccines / biologics drug substance, drug product and analytical. + Proficiency with change control, deviation management and BLA/MAA regulatory license documents. + Demonstrated creative conflict resolution and problem-solving skill. + Strong knowledge of global regulatory guidelines and cGMP principles. + Demonstrated experience with lean operational excellence in manufacturing. + Digital tool competency with One PMO, MS Teams, Power BI, MSPO, Spotfire, SharePoint and other related systems. + Demonstrated ability to create and analyze detailed, cross-functional project plans (including Gantt charting) and manage execution and change against those plans. Current 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. 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: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ 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. 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 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. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 05/10/2025 ***A 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:** R347139