Director, Preclinical Development

Date: May 20, 2019

Location: Rahway, NJ, US

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Requisition ID: PRE000739

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 Oral Formulation Sciences Director within Pharmaceutical Sciences is the leader of a group responsible for the design and development of solid oral dosage forms and manufacturing processes suitable for commercialization, the delivery of clinical supplies to support Phase 1 through Phase 3 studies, and the associated data and regulatory packages to support commercialization. The leader is responsible for the growth and development of junior and experienced formulation scientists ensuring that Oral Formulation Sciences is prepared to meet the needs of the emerging and increasingly complex pipeline. This includes the ability to generate novel product ideas, including applicable novel drug delivery systems and processes, and collaborate with cross-functional stakeholders resulting in the commercialization of robust, stable, and scalable products. The leader is also directly responsible for developing organizational capabilities, managing the scientific excellence of the group, setting objectives, contributing to performance assessments, allocating resources, and ensuring robust cross-functional partnerships. The leader is expected to clearly communicate a vision for the group, energize staff, stimulate creative thinking, and encourage a transparent and collaborative working environment. The candidate should have exceptional communication and interpersonal skills.


Key Areas of Focus:

- Oversees development projects ensuring that appropriate dosage forms and associated manufacturing processes are developed which exhibit optimum physicochemical and biopharmaceutical characteristics, including stability over shelf-life, scalability, and robustness.

- Develops strategy for and operationalizes product development

- Ensures the satisfactory delivery of clinical supplies

- Authors and presents scientific papers and presentations for senior management and external audiences

- Develops external relationships of benefit to Merck

- May lead cross-functional and global teams 

- Liaises closely with stakeholders to support development timelines

- Provides the necessary input for departmental expenditure estimates

- Carries out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements

- Ensures that departmental working practices are in compliance with relevant cGMPs, safety, industrial hygiene and environmental standards


Qualifications

Education Minimum Requirement: 

Ph.D. in Pharmaceutical Sciences, Chemical Engineering or related fields from reputable universities with 5+ years of diverse industry experience.
M.S. in in Pharmaceutical Sciences, Chemical Engineering or related fields from reputable universities with 10+ years of diverse industry experience.
B.S. in in Pharmaceutical Sciences, Chemical Engineering or related fields from reputable universities with 15+ years of diverse industry experience.


Required Experience and Skills**: 

Demonstrated leadership skills and exceptional interpersonal, collaborative and communication skills

Ability to set vision and lead transformational change 

Ability to develop an expectation of high scientific rigor, compliance, and quality in group deliverables

Strong external network as evidenced through collaborations, publication, and patent history.


Preferred Experience and Skills:

Experience in oral formulation development preferred.

Thorough understanding of the regulatory requirements in CMC development. Experience in writing regulatory filings culminating in product approval preferred.



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:

 

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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:
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: active MKs
Company Trade Name: Merck


Nearest Major Market: New York City
Nearest Secondary Market: Newark

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