QC Bioassay Lead, Associate Director - Rahway - MSD Malaysia

    MSD Malaysia
    MSD Malaysia Rahway

    6 days ago

    Description
    QC Bioassay Lead, Associate Director - Dundalk page is loaded## QC Bioassay Lead, Associate Director - Dundalkremote type:

    Not Applicablelocations:
    IRL - Louth County - Dundalktime type: Full timeposted on: Posted Todaytime left to apply:

    End Date:
    March 23, days left to apply)job requisition id: R387387
    Job Description## Join our company as a QC Lead and play a crucial role in ensuring the highest quality standards in our products and services.

    This is an exciting opportunity to lead a dynamic team, drive continuous improvement, and make a significant impact on our quality programs at our state-of-the-art site in Dundalk.

    Our facility is dedicated to formulating and filling vaccine products that improve and transform lives globally.###
    Your Core Responsibilities Develop and lead a world-class Bioassay team QC team, including planning, recruiting, coaching, and training.

    This role will enable you to shape and enhance our team's capabilities.
    • Serve as a technical expert to develop, qualify, and validate bioassay/cell-based potency methods for vaccines in a GMP environment.
    • Prepare, review, and approve technical documents such as method protocols and validation reports.
    • Provide technical guidance, evaluate new analytical technologies, and enhance department capabilities.
    • Oversee GMP quality oversight, including deviations, investigations, change controls, and CAPAs.
    • Manage lab scheduling and planning for Vaccines QC labs, ensuring streamlined workflows and operational efficiency.
    • Lead project management interactions with internal and external clients, including Quality Assurance and Regulatory Affairs.
    • Handle regulatory inspections and GMP audits, ensuring continuous improvement of QC quality systems and safety measures.
    ###
    Who You AreYou are ready if you have:

    BSc or MSc in Biology/Cell Biology, Biochemistry/Molecular Biology, Immunology, Virology or related field. Strong understanding of analytical and QC operations in the biopharmaceutical/vaccine industry. Proven track record in people management, problem-solving, and interpersonal skills. Knowledge of current regulations and industry trends for vaccine development, manufacture, and testing, including cGMP, ICH, EMA, and FDA guidelines. Proven ability to lead continuous improvement initiatives to enhance quality standards and operational efficiency within the QC Bioassay team. Exceptional skills in collaborating with cross-functional teams to integrate QC Bioassay processes and address issues promptly. Strong leadership skills, including strategic planning, innovation, and talent development, with a commitment to diversity, equity, and inclusion.

    Nice to have, but not essential:     PhD or MSc Biology/Cell Biology, Biochemistry/Molecular Biology, Immunology, Virology or related field.
    • Minimum of 8 years of vaccine industry experience preferred, or minimum 10 years relevant pharmaceutical/biopharmaceutical experience in CMC process development and/or GMP manufacturing.
    • Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-3.
    • Proven track record working cross-functionally across a wide variety of technical, business, and operational areas.

    Required Skills:

    Analytical Method Development, Cell Cultures, Deviations, GMP Compliance, Laboratory Management, People Management, Potency Assays, Quality Control (QC), Vaccine Manufacturing, Virology

    Preferred Skills:    Biosafety, Vaccine SafetyCurrent Employees applyCurrent Contingent Workers apply
    Secondary
    Language(s)


    Job Description:    We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

    As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

    Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

    We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

    Please feel free to speak to us about what flexibility means to you during your application.


    So, if you are ready to:Invent solutions to meet unmet healthcare needs,
    please apply today.*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:


    RegularRelocation:

    VISA Sponsorship:*Travel Requirements:

    Flexible Work Arrangements:    Not Applicable
    Shift:*Valid Driving License:
    Hazardous Material(s):*Job Posting

    End Date:

    03/23/2026\*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.**#J-18808-Ljbffr
  • Work in company

    Associate Director

    Only for registered members

    The Analytical Research & Development (AR&D) Stability Operations & Compliance department within our Research & Development Division is seeking applicants for a stability operations Associate Director position available at the Rahway NJ research facility. · The successful candida ...

    Rahway $129,000 - $203,100 (USD)

    1 month ago

  • Work in company

    Associate Director

    Only for registered members

    Job Description · About the role: · The Process Intelligence and Experience Design organization serves as a strategic enabler of enterprise transformation. We bring end-to-end visibility to business processes, connect data and user insights to decision making and ensure that opti ...

    Rahway $142,400 - $224,100 (USD)

    1 week ago

  • Work in company

    Associate Director

    Only for registered members

    Job Description · The Associate Director, Accounting Standards at our Company serves as a key subject‑matter expert responsible for evaluating, interpreting, and advising on complex and non‑routine accounting matters across the organization. This role ensures the company's financ ...

    Rahway $129,000 - $203,100 (USD) Full time

    4 days ago

  • Work in company

    Associate Director

    Only for registered members

    Job Description · The Associate Director, Accounting Standards at our Company serves as a key subject‑matter expert responsible for evaluating, interpreting, and advising on complex and non‑routine accounting matters across the organization. This role ensures the company's financ ...

    Rahway $129,000 - $203,100 (USD) Full time

    3 days ago

  • Work in company

    Associate Director

    Only for registered members

    The Associate Director will develop market access strategies and solutions for assigned brands in the US HIV Payer Marketing team at Merck & Co., Inc. · ...

    Rahway, NJ

    1 month ago

  • Work in company

    Associate Director

    Only for registered members

    The AR&D Stability Operations & Compliance department within our Research & Development Division is seeking applicants for an Associate Director position available at the Rahway NJ research facility. · ...

    Rahway, NJ

    1 month ago

  • Work in company

    Associate Director

    Only for registered members

    The North America (NA) Associate Director of Regional Security (ADRS) will support all the NA Regional GSG's Operations in North America by leading the investigation of escalated GSG investigations. · This specific role will be primarily responsible for approximately six assigned ...

    Rahway $129,000 - $203,100 (USD)

    1 month ago

  • Work in company

    Associate Director

    Only for registered members

    Job Description · The Associate Director, Accounting Standards at our Company serves as a key subject‑matter expert responsible for evaluating, interpreting, and advising on complex and non‑routine accounting matters across the organization. This role ensures the company's financ ...

    Rahway $129,000 - $203,100 (USD)

    3 days ago

  • Work in company

    Associate Director

    Only for registered members

    The North America (NA) Associate Director of Regional Security (ADRS) will support all the NA Regional GSG's Operations in North America by leading the investigation of escalated GSG investigations. · ...

    Rahway $129,000 - $203,100 (USD) Full time

    1 month ago

  • Work in company

    Associate Director

    Only for registered members

    Job Description · The Associate Director, Accounting Standards at our Company serves as a key subject‑matter expert responsible for evaluating, interpreting, and advising on complex and non‑routine accounting matters across the organization. This role ensures the company's financ ...

    USA - New Jersey - Rahway $100,000 - $190,000 (USD) per year

    2 days ago

  • Work in company

    Associate Director

    Only for registered members

    This role is responsible for regional category management and sourcing leadership of Creative, Digital Production & Publishing, and Medical Education within Marketing Procurement. · Bachelor's degree in supply chain, procurement, business administration. · ...

    Rahway $126,500 - $199,100 (USD)

    1 month ago

  • Work in company

    Associate Director

    Only for registered members

    Job Description · About the role: · The Process Intelligence and Experience Design organization serves as a strategic enabler of enterprise transformation. We bring end-to-end visibility to business processes, connect data and user insights to decision making and ensure that opti ...

    Rahway, NJ $100,000 - $190,000 (USD) per year

    1 week ago

  • Work in company

    Associate Director

    Only for registered members

    Job Description · The Associate Director, Accounting Standards at our Company serves as a key subject‑matter expert responsible for evaluating, interpreting, and advising on complex and non‑routine accounting matters across the organization. This role ensures the company's financ ...

    Rahway, NJ $100,000 - $190,000 (USD) per year

    3 days ago

  • Work in company

    Associate Director

    Only for registered members

    The North America (NA) Associate Director of Regional Security (ADRS) will support all NA Regional GSG's Operations by leading investigation of escalated GSG investigations. · Bachelor's Degree minimum or equivalent. · Recognized international security qualifications/accreditatio ...

    Rahway, NJ

    1 month ago

  • Work in company

    Associate Director, Engineering

    Only for registered members

    Our company is seeking an Associate Director of Engineering to manage a significant portion of a very large capital project. · Managing an integrated project team to deliver critical assets on time and within a prescribed budget · ...

    Rahway $142,400 - $224,100 (USD)

    2 weeks ago

  • Work in company

    Associate Director, Engineering

    Only for registered members

    The Associate Director of Engineering supports the FLEx Sterile Operations team in maintaining safety quality regulatory compliance working closely with Operations Quality Environmental Health Safety Regulatory Affairs Facilities Management Engineering and Analytical teams ensuri ...

    Rahway $142,400 - $224,100 (USD) Full time

    1 month ago

  • Work in company

    Associate Director, Engineering

    Only for registered members

    The Rahway FLEx Center is seeking an Manufacturing Engineering Lead to support specialty dosage forms development activities on second shift. · ...

    USA - New Jersey - Rahway $126,500 - $199,100 (USD) Full time

    1 month ago

  • Work in company

    Associate Director, Engineering

    Only for registered members

    We are seeking an Associate Director of Engineering to manage a significant portion of our global capital projects in manufacturing laboratory and infrastructure lines of business. · A bachelor's degree in engineering is required with ten years' experience executing/delivering ca ...

    Rahway, NJ

    2 weeks ago

  • Work in company

    Associate Director, Engineering

    Only for registered members

    The Rahway FLEx Center is seeking a Manufacturing Engineering Lead to support specialty dosage forms and oral solid dosage GMP development activities. Key Responsibilities: · Own technical decisions for the shift; evaluate safety quality equipment status make real-time technical ...

    Rahway $126,500 - $199,100 (USD)

    1 month ago

  • Work in company

    Associate Director, Engineering

    Only for registered members

    The Rahway FLEx Center is seeking an Engineering Director to support GMP development activities. · Evaluate safety, quality, and equipment status. · Make real-time technical determinations on next steps. · ...

    Rahway $126,500 - $199,100 (USD) Full time

    1 month ago

  • Work in company

    Associate Director, Engineering

    Only for registered members

    The Compliance Engineer supports the FLEx Sterile Operations team in maintaining the highest standards of safety, quality, and regulatory compliance. · Lead the development,maintenance,and assignment of training curricula. · Monitor,the track,and report on training completion,eff ...

    Rahway $142,400 - $224,100 (USD) Full time

    1 month ago

Jobs
>
Rahway