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Merck & Company, Inc.

Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. The company provides human health pharmaceutical products, such as therapeutic and preventive agents for the treatment of human disorders in the areas of cardiovascular, diabetes and obesity, respiratory, immunology infectious diseases, neurosciences and ophthalmology, oncology, vaccines, and women's health and endocrine. It also ... Read More

Address      One Merck Drive PO Box 100 Whitehouse Station, NJ 08889-0100 United States
Website      www.merck.com/
Holding      No Holding Details

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Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Position Overview
Biologics Manufacturing Commercialization and Sciences (BMSC), Merck Manufacturing Division (MMD) is responsible for the commercialization of biological processes (novel therapeutic proteins and follow-on biologics) from Phase III through launch and transfer to supply.  Activities include process development, scale-up and optimization, late-stage analytical support. Process and analytical activity include, interfacing with a network of facilities for product manufacturing and subsequent optimization, process and assay validation, analytical technical transfer, BLA filing documentation, and transfer to supply network.  The incumbent will be responsible for coordinating the analytical interface between Merck and external partners and/or contract manufacturing and research organizations (CMO/CRO) in the area of biologics manufacture.  He/she will coordinate with analytical and process development groups to prepare for and coordinate trouble-shooting, assay validation and analytical transfers between Merck, external partners and CMO/CROs. The incumbent will have experience in analytical development and quality control (QC), with a working knowledge of current Good Manufacturing Practices (cGMP).  At any given time, the individual could be responsible for contributing to and coordinating analytical activities across multiple projects. He/she will also ensure alignment with late-stage analytical strategies and Quality Systems.
Additional Responsibilities Include:

    * Coordinate analytical issue resolution as needed via subject matter experts within the global biologics network.
    * Prepare and execute analytical method transfers and assay method validations - write and coordinate review of protocols and reports.
    * Co-author and coordinate reviews of analytical comparability protocols and reports.
    * Provide on-going support to external partners/CMOs/CROs to resolve analytical issues and trouble-shooting.
    * Assist in the development and execution of critical reagent qualification protocols and stability studies.
    * Act as the BMSC representative on cross-functional analytical sub-teams.
    * Assist with the technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods.
    * Contribute as author and reviewer to regulatory submissions including marketing applications.

Position Qualifications:
Education Minimum Requirement:
BS in Chemistry/Biochemistry/Biological Sciences or equivalent
Required Experience and Skills:

    * More than 8 years in bio/pharmaceutical experience (BS)
    * More than 5 years in bio/pharmaceutical experience (MS)
    * 1-3 years in bio/pharmaceutical experience (Ph.D.)
    * Experience with assay development, validation, technical transfer, and trouble-shooting.
    * Late stage analytical experience.
    * Experience preparing and executing biochemical assay validation and transfers protocols and reports.
    * Experience in effectively managing analytical development and testing activity at external vendors such as CMOs
    * Experience with drug substance and drug product release, stability and extended characterization testing for biologics.
    * Experience developing analytical comparability protocols and reports.
    * Strong organizational and project management skills.
    * Strong oral and written communication skills.
    * Ability to work independently with minimal supervision.
    * Effectively identify and communicate risks.
    * Experience with deviation management and change control processes.  

 Desired Experience and Skills:  

    * Ph.D. in Biochemistry/Biological Sciences or equivalent, with 2+ years of relevant late-stage industry experience
    * Experience operating as part of cross functional/cross divisional teams.
    * Experience with analytical support for process development activities.
    * Experience working with contract laboratories and contract manufacturing organizations, and managing relationships with other external partners.

Our employees are the key to our company's success.  We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition # PRO009855. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives
Please Read Carefully:
Merck is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

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Full Time

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