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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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Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products.   Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

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.

Process Development and Commercialization (Biologics) 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, interfacing with a network of facilities for product manufacturing and subsequent optimization, validation and filing documentation, and transfer to supply network.  PDC is part of the Merck Manufacturing Division.
Under the general scientific and administrative direction of the Principal Engineer in Upstream Processing within PDC and working in conjunction with internal and external partners, this individual will support late stage bulk process development, characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to therapeutic proteins (TPs).  The individual will demonstrate scientific, experimental and tech transfer skills focusing on upstream processing.
Technical Scope

    * Participates in late stage process development, characterization, and validation with line-of-sight for licensure and commercialization.  Primary focus will be on upstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including downstream purification, analytical, and site readiness.
    * Actively interacts with internal and external counterparts.  Represents functional area on cross-functional and cross-divisional teams, and communicates the basis and implications of various process and project decisions from within the functional area to outside stakeholders.
    * Responsible for process characterization and process validation studies either in-house or externally (including external partners, CROs and CMOs).  Provides technical leadership for the design of experiments supporting characterization.  Capable of managing remote teams for the execution of lab-based experiments with the ability to conduct hands-on experimentation as needed.
    * Authors required regulatory and technical documentation.  Ensures that process/product are developed and documented according to standard Merck practices.
    * Provides technical support and leadership for Merck's manufacturing processes.  Responsibilities include supporting technical due diligence, technology transfer and technical oversight of clinical manufacturing to external partners, including process monitoring, troubleshooting and continuous process improvement.

Culture and interactions with others:

    * Shows flexibility and agility in responding to changing needs across PDC and Merck.
    * Actively listens and participates in discussions and is appropriately assertive in expressing own ideas. Gives timely constructive feedback when appropriate.
    * Applies new functional and core competencies in a manner that adds value to the organization and shows understanding of the links between individual and team performance.
    * Identifies and utilizes appropriate communications channels to most effectively make contact with key customers, including internal and external partners, and keeps relevant parties informed on progress or issues.
    * Delivers what is needed on-time and holds self and team accountable for commitments, decisions, actions and behaviors.

Position Qualifications:

    * Education Minimum Requirement:
          o BS or MS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with at least 6 years relevant experience.
          o Or, Ph.D. in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with at least 0-3 years experience.
    * Required Experience and Skills:
          o Technical expertise in upstream, cell culture processing of biological molecules from mammalian-based expression systems, including bioreactor experimentation.
          o Demonstrated technical communication skills and ability for independent project leadership.  
          o Experience with technology transfer and scale-up of manufacturing processes for biologics manufacture
          o Excellent oral and written communication skills
          o Strong organizational and project management skills; ability to prioritize tasks, track and communicate progress as needed
    * Desired Experience and Skills:  
          o Experience with upstream process development of biological molecules required, with an in-depth knowledge of cell culture, passaging, bioreactor operation and experimentation, harvest and primary recovery (including centrifugation and depth filtration) desired.  Experience with microbial expression systems is a plus.
          o Prior experience in late stage bulk process development, process characterization, process validation, site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing is a plus.
          o Working understanding of analytical methods to characterize biologics and /or US/EU regulatory requirements and / or working knowledge of cGMPs is a plus.
          o Demonstrated ability to lead and collaborate within cross-functional and/or remote teams.

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 # CHE003603. 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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