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Director GMP

Requisition ID: PRE000697
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.
The primary objective of the Analytical Sciences (AS) team is to carry out R&D activities supporting formulation & process development and clinical trial material testing in Pharmaceutical Sciences. In this position the Analytical Sciences Director will set guidance, lead activities and develop a team whose roles include development and validation of GMP analytical characterization methods to characterize and release clinical drug product and their stability tests, raw materials/excipients, and packaging components for our research pipeline. Further, the director will lead efforts on GMP compliance, data integrity, SOP development and quality systems for the laboratories. This research opportunity is fast paced and contributes to Pharmaceutical Sciences deliverable which is the development of robust market formulations and their processes for non-sterile and sterile products.
This challenging position requires vision to develop a team, demonstrated leadership skills, critical thinking, strong technical and communication skills, strong understanding of the regulatory environment, and vision to influence the regulatory environment.
Nature and Scope of Position:
The Director reports to the Executive Director of Analytical Sciences and will lead a team in Rahway ( 10 - 15 scientists) who work closely within multidisciplinary Pharmaceutical Sciences teams. This role has a wide responsibility for parenteral, oral, and specialty dosage form method development and testing and delivering results within fixed timelines. The role will also include the exciting opportunity to be a leader in the development, implementation and maintenance of a GMP testing laboratory within a new-state-of-the-art formulation development center which will supply clinical materials. The Director should be well engaged with regulatory and industry trends to guide future activities for Analytical Sciences and Pharmaceutical Sciences. The successful candidate will have experience in an innovative analytical/regulatory/GMP environment.
Further the Director will be responsible for identifying work appropriate for contract research organizations / service providers and ensures that appropriate quality and time attributes are achieved. The Director will effectively team with the Analytical Sciences leadership, and extended leadership teams in order to identify and advance key departmental strategic and cultural initiatives. The Director will identify, recruit, onboard and develop employees to their full potential. S/he will contribute and establish a viable succession plan for key positions within the functional area (scientific and management pathways), including their own role. The position is responsible for approves disclosures prepared within her/his group to be used as the basis for external publications and filings.
Essential Knowledge, Duties & Responsibilities include:
Pharmaceutical Analytical Methodologies
Project management skills
Review and approval of data
Representation of the laboratory for internal and external audits
SOP development
Quality System experience
Assessment of new microbiology technologies
LIMS
Team and staff development
Investigations
Thorough working knowledge of GMPs, ICH, and relevant FDA guidelines
Qualifications
Education:
BS or MS in Chemistry or related science with 10 years of industrial experience with pharmaceutical drug product development.
Ph.D. in Chemistry or related science with 7 years of industrial experience with pharmaceutical drug product development.
Required Experience and Skills:
Industrial experience with GMP testing of drug product testing
Preferred Experience and Skills:
Demonstrated ability in leading a team
The successful candidate will have experience in an innovative analytical/regulatory/GMP environment.
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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.
Job: Preclinical Dev Generic
Other Locations: West Point, PA, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: MK compounds (OEB1-5)
Company Trade Name: Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark


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