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Assoc. Dir, Bio Bac Process Engineering Lab

Merck


Location:
West Point, PA
Date:
08/30/2017
2017-08-302017-09-29
Job Code:
CHE005503
Merck
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Job Details

Job Title: Assoc. Dir, Bio Bac Process Engineering Lab  - CHE005503

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 125-year legacy. 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 Associate Director of the Bio Bacterial Process Engineer Lab will be responsible for the management and oversight of the BBM Technical Operation Lab within the BBM End-to-End, at the West Point site. The primary responsibility of the individual will be leading a technical team of 2-6 FTEs in developing lab scale models, utilizing new analytical methods to enable process understanding, drive continuous improvement and leading deep dive process investigations. The Associate Director will have overall responsibility for the performance and results of the Bio Bacterial Process Engineer Lab. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.

Responsibilities Include but are not limited to:
  • Process SME for BBM: Support E2E manufacturing operations including but not limited to seed, cell bank, raw materials, drug substance, drug product and analytical
  • Designs and conducts experimental protocols using the Technical Operations lab facilities and/or production equipment at full scale. Capable of communicating data driven results to all levels of the organization.
  • Leads and/or coaches employees on complex manufacturing investigations and process improvement projects.
  • Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
  • Coach, manage, and develop a team of scientist/engineers through a direct reporting relationship. Recruits and hires engineers and scientists.
  • Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
  • Serve as a primary technical reviewer/approver for investigations and significant process changes.
  • Links with key functional leads on site and above site to provide input on behalf of the site team.
  • Builds talent by coaching and developing the members of the Technical Operations team to ensure appropriate breadth, depth and skill sets across the team to maintain and drive the business forward. Provides/solicits regular feedback from team and colleagues. Develops technical/professional staff through coaching, assignment selection and associated training.
  • Manages team resources and prioritizes as aligned with business needs to include run the Business support (e.g. investigations, complaints), project support, and continuous improvement activities – e.g. improve safety/compliance, reduce cost and increase consistency and efficiency. Recruit and hire team members as necessary. 
  • Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements. Provide experimental support for franchise level projects/investigations.
  • Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions. Includes approval of technical documentation including investigation, protocols, qualification, validation etc. as required. Responsible for presenting technical discussions to regulatory agencies during inspections.


Qualifications
Education:
  • Bachelor’s Degree or higher in Engineering or Science
Required:
  • Minimum 7 years’ relevant work experience, including direct experience in lab operations or process development
  • Demonstrated leadership and ability to drive results
  • Strong communication, collaboration skills and ability to drive accountability
Preferred:
  • Master’s or PhD Degree

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 .

 

Search Firm Representatives Please Read Carefully: 

Merck 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:



Job Chemical Engineering

Primary Location NA-US-PA-West Point

Other Locations 

Employee Status Regular

Number Of Openings 1

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