Skip to main content

This job has expired

Engineer- Sterile Clinical Manufacturing Process Lead Job

Job Details

Engineer- Sterile Clinical Manufacturing Process Lead-PRO013992

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.


The Process Leader will report to the IPT Lead and will be responsible for providing tactical and strategic level direction to the IPT's internal technical services staff consisting of process engineers and technical subject matter experts.

The process leader will be expected to build and sustain strong relationships with process experts in other key partner groups including Sterile Liquids Commercialization, Pharmaceutical Sciences, Sterile Product Development, and Vaccine Formulation / New Technology Development. These relationships will give SLP visibility to emerging technical needs and will help drive consistency across development and manufacturing processes.

The role of the process leader is to promote the behaviors and principles that drive continuous improvement within the IPT's process group in partnership with other members of the IPT leadership team and leaders from key partner groups.

Responsibilities include management of personnel and business processes, setting objectives and overall direction for the process group, developing people, processes, and new technologies.

Responsibilities include but are not limited to the following:

- Responsible for ensuring systems are in place and personnel are trained to compliantly and productively support early development through Phase III clinical production within the sterile liquid pilot plants.

- Responsible for identifying and developing technologies and business practices to support Lean manufacture and gain competitive advantage.

- Provide technical input on batch processing.

- Development of staff and creation of an ownership culture through targeted leadership assignments, training and technical development opportunities.

- Develop and define interfaces with partner groups and establish clear channels for external collaboration for the IPT's process group.

- Focus on process development groups, Quality, and the MRL Global Clinical Supplies organization.

- Establish objectives for the IPT's process group.

- Balance efforts of staff between long term area improvement and shorter term production requirements, with consideration given to GPC and MRL priorities.

- Provide direction to team and define requirements for success in areas of technology, compliance and continuous learning.

- Assign IPT staff as appropriate to meet campaign requirements.

- Develop each staff member in a way which focuses on gaining fluency in the targeted behaviors and competencies required of each team member.

- Coach to improvements through clear direction, creation of opportunities for growth, demonstration of new skills and career pathing, and establishment of systems which motivate staff members to perform and remain engaged.

Qualifications

Education:

- Bachelors of Science in Chemical Engineering, Chemistry, Biology or related Scientific Field
Required:

- Minimum 5 years of experience with a heavy focus on sterile product formulation and filling technology.

- Minimum 3 years of team management responsibility

- Strong understanding of process equipment and best practices related to equipment use.

- Able to articulate a vision for the IPT's process group and partner groups that is aligned with the Merck strategy

- Strong communication and collaboration skills, especially with groups outside the IPTs

- Champion of new ideas and MPS, embraces change

- Sound decision making skills, drives results

- Able to work collaboratively with a diverse workforce, both inside and outside IPTs

- Functions effectively in a dynamic environment while balancing needs of process development and clinical production

- Focused on leadership development of staff

Preferred:

- Experience in process development oriented roles

- Capability to identify and sponsor lean initiatives and to holistically develop and implement lean systems.

- Lean Six Sigma certification

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.

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: Process Engineering

Job Title:Assoc. Dir, Engineering

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Hazardous Materials: Phenol, BSL-2, OEB- 4 products

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert