Director, Elkton Vaccines and Biologics Process Development Job

Director, Elkton Vaccines and Biologics Process Development-CHE005506

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 Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Director, Elkton Vaccines and Biologics Process Development will oversee the process development laboratory at Merck’s Manufacturing site in Elkton, VA. This laboratory support late stage process development for in-line and pipeline products, laboratory support for existing products to enable process optimization and troubleshooting and microbiology support for all manufacturing areas in Elkton including wastewater treatment.

Responsibilities include but are not limited to:

The Director, Elkton Vaccines and Biologics Process Development guides the activities of, and administratively manages, a professional staff of ~20 to develop, commercialize and support new biologics and vaccine products at Elkton. This includes establishment and qualification of scale down models, late stage process development and characterization, ownership of process descriptions, risk assessment and control strategy as well as the tech transfer of the process to commercial scale. The incumbent should be externally recognized as a thought leader in vaccines and biologics commercialization.

The incumbent will serve as the lead technical author and reviewer of CMC section of the associated regulatory filings for new products. This role serves as the primary interface with the CMC department, has accountability for the assembly of the technical content of the CMC package and owns technical readiness for the pre-approval regulatory inspection. The bulk of this work is done through cross-functional management of a large team of contributors on site and external to the site. This requires broad anticipation of industry wide technical, regulatory and compliance issues and proactive resolution of these challenges.

The incumbent will serve as the primary contact for the site on product development and commercialization teams. This includes leading the Drug Substance Working group (a cross functional site wide team that owns the drug substance process during commercialization). Serves as interface with all external parties related to the commercialization of the product, including CRO and CMOs. This role is a key player in the development of commercialization strategy for the new product as well as the strategy for the Elkton site.

Qualifications

Education:

- Bachelors, Masters or PhD in Engineering or Biological Science

Required:

- Minimum of 8 years experience in large molecule process development

- At least 5 years of direct management experience

- Large molecule (vaccines and biologics) process development and commercialization experience

Preferred:

- Technology transfer, new asset realization and start-up experience

- Knowledgeable of cGMP’s, financial principles, safety guidelines, engineering standards, and regulatory issues.

- Demonstrated interpersonal skills including flexibility and ability to work in a team environment.

- Technically proficient and has demonstrated managerial and leadership skills necessary to build and maintain a high-performance group of technical professions.

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.

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 not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



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


Job: Chemical Engineering

Job Title:Dir, Engineering

Primary Location: NA-US-VA-Elkton

Employee Status: Regular

Travel: No

Number of Openings: 1

Shift (if applicable): N/A

Company Trade Name:Merck