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  • Technical Lead - Lyophilization - Global Animal…

    Merck (North Wales, PA)



    Apply Now

    Job Description

    This is a fantastic opportunity to make a substantial impact in establishing new lyophilization manufacturing. As announced earlier in 2025, our Animal Health division is investing $895M to expand manufacturing and R&D in De Soto, Kansas— the 2nd largest economic development project in the state’s history. This new role in in Global Animal Health Manufacturing (GAHM) Biotechnology Solutions (BTS) will serve as the leading scientific authority for the new commercial lyophilization (freeze‑drying) capacity being built at the site.

     

    This role is the Technical Lead for Lyophilization with both deep scientific experience and practical commercial manufacturing judgment. You will lead technical strategy, science‑based technology transfer and scale‑up of freeze‑drying and fill‑finish processes for vaccine and biologic drug products used in Animal Health. This role partners closely with Large Molecule strategy, regional operations, capital engineering, and process development/R&D.

    What we offer:

    + Opportunity to lead technical strategy for a major investment in Animal Health manufacturing and R&D.

    + Collaborative environment where scientific rigor and practical manufacturing experience are valued.

    + Competitive compensation and benefits; career development and leadership opportunities within a global manufacturing network.

     

    If you are a science‑driven technology steward for lyophilization and fill‑finish, passionate about applying first‑principles engineering to deliver safe, robust animal health vaccines and biologics at scale, we’d like to hear from you.

    Why this role matters:

    + Influence design and scale‑up decisions for freeze‑drying cycles and integrated fill‑finish operations that affect product quality, throughput, and regulatory compliance.

    + Act as the internal and external subject matter steward — translating theory to practice, mentoring teams, and elevating standards across R&D and commercial manufacturing.

    + Drive continuous improvement and risk‑based technical governance at this new lyophilization site.

    Key Responsibilities:

    + Provide authoritative scientific guidance and technical stewardship across commercialization, tech transfer, and scale‑up of lyophilization and aseptic fill‑finish processes.

    + Lead first‑principles characterization of products and equipment (primary packaging, shelves, vials/stoppers, trays, bulk fill systems) and apply mathematical and heat/mass transfer modeling to design and optimize freeze‑dry cycles and loading strategies.

    + Own the technical aspects of lyophilization tech‑transfer: develop acceptance criteria, comparability strategies, process design space, and critical process parameter (CPP) rationales for transfer from R&D to commercial lines.

    + Partner with capital engineering and vendors to specify freeze‑drying equipment, auxiliary systems, and automated fill‑finish lines; provide technical input to FAT/SAT protocols, installation qualification (IQ/OQ), PQ, Post-PQ testing, transfer batches and commercial manufacturing.

    + Collaborate with regional operations and QC/QA to ensure readiness: process validation/qualification planning, batch record design, change control, deviations assessment, and regulatory file support.

    + Translate complex scientific literature into actionable process improvements; represent the company in external industry/regulatory forums, standards bodies, and scientific publications where appropriate.

    + Coach, train, and mentor cross‑functional project teams (R&D, process development, manufacturing tech ops, engineering) to build internal capability and promote sound scientific practices.

    + Maintain technical roadmaps, best‑practice libraries, and decision frameworks that balance innovation with animal health quality and regulatory expectations.

    _Who you are (profile):_

    + Recognized, published authority in lyophilization/fill‑finish for biologics or vaccines with a track record of applying science to commercial manufacturing.

    + Experienced at guiding technical decisions across R&D and commercial manufacturing with strong systems thinking and governance discipline.

    + Practical experience with freeze‑dry studies, cycle development and optimization, load configurations, and product characterization (residual moisture, collapse, reconstitution).

    + Comfortable using mathematical modeling and data‑driven approaches (e.g., heat/mass transfer, primary drying kinetics, mathematical models to inform scale‑up and tech transfer decisions.

    + Fluent in quality and regulatory expectations for vaccines/biologics, and pharma technical documentation (protocols, validation reports, change control, deviations, regulatory submissions).

    _Minimum qualifications_

    + Bachelor of Science in Biology, Chemistry, Chemical Engineering, or related technical discipline required.

    + Preferred: PhD or advanced degree with specialization relevant to vaccine/large molecule manufacture (or equivalent technical experience).

    _Experience & skills_

    + Minimum ~7 years’ relevant experience in vaccines, biologics, pharmaceutical, or related industries, spanning R&D, tech transfer, or commercial manufacturing support.

    + Direct hands‑on experience planning and conducting freeze‑dry studies and assessing commercial lyophilization processes.

    + Demonstrated capability in product and equipment characterization, process development, and scale‑up for lyophilization and aseptic fill‑finish.

    + Strong written and verbal communication; proven ability to influence cross‑functional stakeholders and train technical teams.

    + Familiar with change control, deviation management, protocol/report authorship, and regulatory license documentation.

    _Preferred qualifications_

    + Published papers, conference presentations, or recognized contributions in the domain of lyophilization.

    + Experience working across both R&D and commercial manufacturing environments in Animal Health or human biologics.

    Required Skills:

    Aseptic Manufacturing, Aseptic Processing, Biologics, Driving Continuous Improvement, Drug Product Development, Fill and Finish, Formulation Optimization, Freeze Dry, Freeze Drying, Good Manufacturing Practices (GMP), Manufacturing, Manufacturing Operations, Manufacturing Scale-Up, Strategic Thinking, Technical Issues, Technical Problem-Solving, Technology Transfer, Vaccine Manufacturing

    Preferred Skills:

    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/)

     
     

    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”.

     

    The salary range for this role is

     

    $126,500.00 - $199,100.00

     

    This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

     

    The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

     

    We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

     

    You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

     

    **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:

    Yes

    Hazardous Material(s):

    N/A

    Job Posting End Date:

    11/14/2025

     

    *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:** R361112

     


    Apply Now



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