Job Description Due to continued growth, our company is hiring an Associate Director, Engineering within the Large Molecule External Manufacturing Technology team. This role will serve as the key technical interface between our company and External Partners for the biologics, vaccines, and sterile product manufacturing network. The Associate Director will lead and execute technical transfers and commercial supply from External Partners, navigating complex drug substance and product networks. The role requires collaboration across multiple technical functions to ensure successful transfers and commercial manufacturing, as well as leadership of high-impact, cross-functional teams.The Associate Director is accountable for achieving excellence in compliance, supply, continuous improvement, and cost reduction, in partnership with internal technical teams and External Partner leadership. This individual will work closely with the Large Molecule Focus Factory Operations lead, Technology Leads, External Quality Assurance, and Procurement to support both new and in-line product transfers. With a strong background in biologics or vaccine manufacturing, process sciences, and analytics, the ideal candidate will have proven leadership, business acumen, and the ability to drive technical risk management across a rapidly expanding third-party manufacturing network.Travel Requirements: >30% for partner assignments outside of primary location (primarily traveling within designated US region). Travel and flexibility in partner assignment location is required; assignments may require short term travel assignments. Job Details: The primary focus of the Associate Director is to provide technical and project leadership to Large Molecule External Manufacturing business for:
Provides a single point of technical contact to assigned External Partners, impacted our company's sites, and Commercialization.
Provides technical oversight, management, and planning support for complex partnership models. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues
Accountable to External Manufacturing for overall tech transfer delivery (on-time, within budget), working closely with the Operations Unit leadership to assure resourcing for each activity.
Provides technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
Collaborates with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate External Partner(s) for inclusion in our company's Network. Executes technical due diligence assessments at External Partner(s).
Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.
Leads team for identification and assessment of partner risks and develops mitigations plans.
Develops and executes validation strategies for new and existing products.
Provides manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
Ensures targeted communications and alignment across technical functions. Guides and coaches others in change leadership.
Support/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites
Determines resource plans across all relevant technical functions.
Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes. Minimizes duplication of efforts between External Partner and our company's systems.
Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility.
In concert with Commercialization, Quality, and Regulatory, ensures that External Partner(s) are inspection ready for all new product introductions and transfers.
Understands the true regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.
Collaborates with External Partners to achieve business goals and to establish a common culture that benefits both our company and EP.
Minimum Education Requirements and Experience:
Bachelor’s degree (BA/BS) in Engineering, Science or applicable Science, or Business with ten (10) years’ experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing, engineering, and/or technical support of operations; OR
Master’s degree (MA/MS) in Engineering, Science or applicable Science, or Business with eight (8) years’ experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing, engineering, and/or technical support of operations; OR
PhD in Engineering, Science or applicable Science, or Business with three (3) years’ experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing, engineering, and/or technical support of operations
Required Skills and Experience:
Expertise and demonstrated accomplishments leading technical transfers is required.
Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues is required.
Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) is required.
Preferred Skills and Experience:
Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s) is preferred
Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements is preferred
Ability to motivate a team around a common vision and deliver expected results is preferred.
Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and process troubleshooting is preferred
Experience in complex international environment with matrix organization structures is preferred
Experience in Large Molecule (i.e. Monoclonal Antibody) unit operation design, startup, and/or operation is preferred.
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.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 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 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: No relocationVISA Sponsorship: NoTravel Requirements: 25%Flexible Work Arrangements: HybridShift: 1st - DayValid Driving License: NoHazardous Material(s): n/aJob Posting End Date: 02/26/2025A 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: R335799