Sr. Scientist, Global Vaccines & Biologics Job

Sr. Scientist, Global Vaccines & Biologics-PRO014421

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and 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 an individual 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 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 Senior Principal Scientist in Downstream 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 downstream processing.　

Technical Scope:　

- Participates in late stage process development, characterization, qualification and validation with line-of-sight for licensure and commercialization.　 Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, analytical, and site readiness.

- Actively interacts with internal and external counterparts.　 May represent functional area on cross-functional and cross-divisional teams.

- Responsible for process development, characterization, process performance qualification (PPQ) and validation studies performed either in-house or externally (including external partners, CROs and CMOs).　 Provides technical leadership for the design of experiments, data analysis and interpretation supporting characterization, as well as the execution of (internal) or management of (external) laboratory activities.　

- Authors required regulatory and technical documentation.　 Ensures that process/product are developed and documented according to standard Merck practices.

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.

- Delivers what is needed on-time and holds self and team accountable for commitments, decisions, actions and behaviors.

Qualifications

Education:

- BS or MS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 5 years (for BS) or 3 years (for MS) relevant experience.

- PhD candidates with 0+ year(s) of relevant experience will also be considered.

Required Experience:

- Technical expertise in purification of biological molecules to include laboratory skills in chromatography and filtration systems.　

- Experience with technology transfer and scale-up of processes to pilot and manufacturing scales for biologics manufacture

- Excellent oral and written communication skills

Preferred Experience:

- Experience with downstream purification of biological molecules required, with an in-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired.　 Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.

- Technical operations experience in the manufacture of biological molecules at the pilot- and/or commercial-scale is a plus.　

- Proven experience with execution of laboratory studies to support late stage bulk process development including viral clearance studies, process characterization and process validation studies

- Experiences in site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing is a plus.

- Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software's)

- Working understanding of analytical methods to characterize biologics and /or US/EU regulatory requirements and / or working knowledge of cGMPs is a plus

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. Our Company’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. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. 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.

Visa sponsorship is available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Process Engineering

Job Title:Sr. Scientist, Engineering

Primary Location: NA-US-NJ-Kenilworth

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Shift (if applicable): N/A

Hazardous Materials: Biologics process development laboratory work.

Company Trade Name:Merck