Mgr, Engineering
Mgr, Engineering
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Job Description
Job Description
The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham NC. This state-of-the-art facility established in 2004 manufactures our Companys lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Companys Vaccine Manufacturing network the facility has seen rapid growth in production volumes and new employees over the last several years as well as future anticipated growth as part of the new product vaccine tech transfers to the facility.
The Process Support Lab at the Durham site is seeking a Manager with outstanding interpersonal communication and collaboration skills. The PSL Manager will be responsible for participating in lab execution as well as leading a team of scientists and engineers that are study leads for processing steps. The candidate must have demonstrated people management skills as well as ability to support and mentor others on data analysis technical writing and lab execution / operations. The Manager will be responsible for leading and/or supporting their team to lead diverse experiments in lab-scale vaccine process development technical transfer support and post commercial process enhancements activities for multiple pipeline vaccine programs as needed based on our dynamic project portfolio. To be successful in this role you will need to be an energetic technical contributor with strong social communication partnership and leadership skills.
The candidate will be required to work in a fast-paced environment. Off-shift or weekend coverage will occasionally be needed to assist the technical team based on project-specific assignments and/or the vaccine production schedule.
Primary Duties:
Manage PSL study leads on the team including downstream unit operations.
Serve as a team Subject Matter Expert in technical data analysis. Leverage these skills to serve as a mentor in up-skilling and supporting peers in statistical tool and graphing techniques for experimental design analysis and process monitoring of manufacturing and Quality Operations testing as needed.
Provide technical review and/or approval of PSL team experimental design proposals analysis technical protocols and reports.
Leverage diverse technical background (upstream downstream drug product) to lead and support late-stage process development scale-down model development/ execution/ implementation process characterization commercial technology transfer and qualification studies. Support workstreams associated with the development and implementation of processes systems and facilities related to vaccine drug substance and drug product.
Actively participate on cross-functional teams to advance project goals and deliverables related to vaccine processes or analytics.
Lead technical operational and business system process improvement projects.
Provide SME knowledge for manufacturing investigations (Product process and testing deviations)
Required Education Experience and Skills:
Bachelors degree in Engineering or Science AND a minimum of five (5) years of relevant experience OR
Masters degree in Engineering or Science AND at least three (3) years of relevant experience OR
Ph.D. with relevant academic experience
Proven leader with demonstrated people management experience
Proficient using statistical tools (JMP or Minitab) for experimental design data analysis and control chart trending.
Hands-on experience and technical knowledge in at least one area of large molecule bioprocessing (ie upstream downstream and/or drug product)
Experience authoring technical documentation within a cGMP context
Project strategic plan development and management
Ability to foster a collaborative work environment focused on mentorship coaching and Subject Matter Expert development
Preferred Experience and Skills
Vaccine or biologics manufacturing within an aseptic cGMP environment
Large molecule process development or relevant experience including scaling (up and down) or tech transfer of downstream large molecule drug substance processes (chromatography centrifugation filtration)
On-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations
Ability to drive studies and experiments in the context of a long-term commercialization plan
Design of Experiment (DOE) and One Factor at a Time (OFAT) experimental design
Ability to provide scientific mentorship and guidance to technical colleagues
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U.S. Hybrid Work Model
Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Applied Engineering Applied Engineering Business Process Re-Engineering (BPR) Chemical Engineering Fundamentals Chemical Plant Operations Chromatography Collaborative Communications Conflict Resolution Cytometry Cytopathology Data Analysis Deviation Management Driving Continuous Improvement Equipment Maintenance Estimation and Planning Fast-Paced Environments Good Manufacturing Practices (GMP) Hydrogenation Instrumentation Management Process Manufacturing Processes Oxidation Processes People Leadership Polymer Processing Production Process Development 4 morePreferred Skills:
Job Posting End Date:
06/9/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Manager
Employment Type
Full-Time
