Associate Director, Downstream IPT Support Team Job

Associate Director, Downstream IPT Support Team-CHE004869

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.


General Summary:

Within the Varicella Bulk Facility’s (VBF) Downstream Integrated Process Team (IPT) Support Team there is an opportunity to lead a team who supports day-to-day activities and strategic projects to ensure the Pooling and Sterile Supply Suite operate Right-First-Time (RFT) in a compliant, safe, and cost effective manner. The opportunity requires daily collaboration with Technical Operations, Operations, and Quality. As part of the Downstream IPT Support Team it will be expected that the selected candidate and their team be first responders to requests from the manufacturing areas as technical issues arise during production.

The well-qualified candidate must have strong analytical, problem-solving, and troubleshooting skills as demonstrated by a consistent track record of solutions for technical problems. In this role, the candidate will provide management and coaching for technical resources assigned to day-to-day support of the manufacturing of aseptic products. Critical to success is to accomplish objectives, to derive, communicate, and implement solutions to improve the compliance, supply, or capacity for live virus vaccine production. Furthermore, the candidate must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. Off-shift or weekend coverage may occasionally be required to support the technical team, based on project-specific assignments or the vaccine production schedule.

General Profile:

•Single point of accountability for developing and delivering on the Downstream IPT Support Team’s objectives
•Single point of accountability for technical support of the Pooling and Sterile Supply IPT
•Single point of accountability for Downstream IPT Support Team hiring and recruiting
•Serve as primary technical review/approver for significant investigations and process changes
•Accountable for the coaching and development of the Downstream IPT Support Team (3-4 direct reports)
•Coach those leading complex manufacturing investigations and process improvement projects
•Coach those providing technical support to the manufacturing shop floor
•Coach those trouble shooting and resolving unplanned events to ensure reliable supply of vaccine bulk

Qualifications

Education Minimum Requirement:

•B.S. degree in Engineering or Sciences

Required Experience and Skills:

•Minimum 6 years GMP experience or ≥4 years GMP with an advanced degree
•Sterile vaccine manufacturing experience as either a Technical contributor or Operations Lead

Preferred Experience and Skills:

•Deep expertise in the field of aseptic processing
•Advanced degree (MS, PhD) in science or engineering
•Regulatory inspection presentation experience with external health authorities
•Strong understanding of process risk assessment tools and Lean Six Sigma methodologies
•Working knowledge of Excel, Minitab, and JMP
•Six Sigma certification
•Experience with Clean-in-Place and Sterilize-in-Place applications
•Experience with hygienic process equipment
•Experience with Autoclaves, Parts Washers, and/or Dry Heat Ovens

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 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:Assoc. Dir, Engineering

Primary Location: NA-US-NC-Durham

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: Cleaning Chemicals (i.e. IPA, CIP 100, CIP 220, hypchlor)

Company Trade Name:Merck