**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. As part of Our Company’s Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. CCFS supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. Under the general scientific and administrative direction of Principal Scientist in the CCFS group and working in conjunction with internal and external partners, this person will support late stage and commercial large molecule program activities within CCFS. The person will be responsible to support development activities, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing vaccines and biologics. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring. **Technical scope:** + Directs project team focusing on process characterization, technology transfer and validation of biopharmaceutical molecules with line-of-sight for licensure and commercialization. + Responsible for planning or executing scale studies to support commercial process validation, process characterization, and investigation evaluations, including studies performed either in-house or externally. + Design, plan, and execute laboratory experiments to generate high quality data. Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports. + Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within our Company network and at contract manufacturing organizations (CMOs). + Provides technical leadership in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA). Lead technical investigations and process changes that drive improvements to yield and/or robustness. + Authors required regulatory and technical documentation associated with process Tech Transfer and validation.  Ensures that process/product are developed and documented according to standard company practices.  Supports regulatory queries and inspections as required. + Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner. **Minimum Required Education and Experience:** + Bachelor’s Degree in in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with five (5) years of cell culture experience in pharmaceutical industry; **OR** + Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with three (3) years of cell culture experience in pharmaceutical industry; **OR** + Ph.D. in in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with no experience. **Required Expertise and Skills:** + Large molecule process development, including scaling (up and down) and tech transfer of drug substance processes.   + Expertise in upstream lab scale experimental execution, Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions.  + Expertise authoring technical documentation to support regulatory submissions leading to product licensure.  + Outstanding communication and people skills. Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.  + Working comprehension of analytical methods to characterize large molecules, US/EU regulatory requirements and working knowledge of cGMPs principles and regulations. **Preferred Expertise and Skills:** + Hands-on expertise with mammalian cell culture bench scale and high-throughput bioreactor systems (e.g. 2L,3L, Ambr250) and ability to oversee teams through these requirements as lab lead. + Expertise with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations. + Expertise with mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles.  + Expertise supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA). 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/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.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 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:** Not Applicable **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 03/12/2025 ***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:** R337582