Release & Stability Coordinator (Raw Materials / Culture Media, and Vaccine / Biologics Drug Job

Employer
Merck
Location
West Point, PA, US
Posted
September 01 2017
Discipline
Other
Organization Type
Pharma
Release & Stability Coordinator (Raw Materials / Culture Media, and Vaccine / Biologics Drug Substance / Product GMP Clinical Supplies)-BIO004928

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Applications are being sought for a Release and Stability Coordinator position in MRL’s GxP Systems Group. The individual will support pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies.

The incumbent will be responsible for the generation and review of documentation for the submission, and testing of raw materials, culture media, excipients, clinical lots materials (drug substance and/or drug product), stability studies, and other materials of regulatory interest.

Responsibilities include release and stability protocol development, forecasting submissions for internal and external testing laboratories, managing clinical supply re-evaluation dating, preparing/maintaining appropriate critical GMP documentation through the use of laboratory information management system (RLIMS), document management systems (MIDAS) and change management software (Trackwise). The incumbent will also participate in cross-functional project team meetings, support regulatory filings, and adhere to clinical study initiation timelines.

Management of critical documentation requires adherence to cGMPs and internal policies and procedures and use of validated IT systems.

Qualifications

Education

- Bachelor of Science or equivalent degree in a related field

Required:

- At least three years of experience working with cGMPs.

- Experience with Release and Stability management

- Experience working with LIMS systems, validated document repositories (MIDAS or Documentum), and Change Management software (Trackwise)

- Understanding of applicable regulations and guidelines governing clinical supply manufacture and release (CFR, ICH)

Preferred:

- Strong communication, interpersonal, and organizational skills, including time management.

- Candidate must have the ability to work independently on several projects maintaining critical timelines.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

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

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


Job: Biological Manuf-Pilot Plant

Job Title:Scientist, Biologics Pre Manf

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Number of Openings: 2

Company Trade Name:Merck