Job Description
Manufacturing Support and Optimization (MSO) serves a key role within LM S&T-GSTS (Global Science Technology Services) to leverage data and DS/DP technology to identify and implement optimization for in-line manufacturing (yield, inventory reduction, throughput, CoGm, waste reduction), and support/Lead complex technical investigations. Our stakeholders and customers include the large molecule manufacturing sites, technical product leadership teams, commercialization teams, and Value Chain Management Teams. We deliver business value to our customers by enabling digital and data capabilities, enhancing process robustness, improving productivity, and reducing waste in the manufacturing processes. This is achieved by focusing on our customers' needs, sponsoring and prioritizing digital initiatives, collaborating with Digital MMD, applying data science to identify opportunities for improvement, and leading or supporting the execution and implementation of digital and data projects.
The Associate Director position is responsible for leading yield improvement projects across both vaccine and biologics products, supporting significant investigations through data aggregation and analysis, and developing fit for purpose dashboards to support major investigations. The goal is to provide value to the organization by using the power of the process and analytical data to collaborate with Site and Global Tech Operation, Operations, and Quality to drive yield improvements and/or determination of root cause for significant investigations.
Additionally, this position will provide critical technical SME support for the China Agency QN review and approval as part of vaccine batch release requirement in China. The goal is to achieve the "right first time" QN review to ensure our Company's Vaccine products on time released into China market. The candidate will collaborate closely with the Site Tech Operation and Quality, Global Tech Operation and Quality, and China In Market Quality in the QN review preparation. The candidate will also be responsible to conduct the presentation mock run with China In Market Quality. The candidate needs to be available to attend the QN review meeting with Chinese Agency as needed, and also follow up with the question raised during the Agency Review. In addition to the China QN review, the candidate will also support other China related inquires and response, including inspections.
Position Responsibilities and Capabilities:
Managing multiple technical projects and assembling and leading multidisciplinary teams to design and implement new systems/technology/standards.Encourage and lead in use of digital and data as enabling technologies to achieve company objectives.Utilizing sound scientific and engineering principles for problem solving and recommending changes in production processes for select vaccine and biologics franchises.Use process and analytical data to drive to increased process understanding and/or root cause determination for significant investigationsResponsible for the QN summary initiation and obtain the approval from site IPTProvide technical SME's assessment on the QNProvide technical translation to Chinese to ensure the technical meaning is properly translatedProvide mock run to prepare the China In-Marketing teamBeing present during the China Agency QN reviewResponsible for the follow up questionsTeaching, coaching, mentoring, and learning from team members.
Education Minimum Requirement:
B.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry or related life science or engineering discipline and a minimum of eight years of relevant industrial experienceM.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry or related life science or engineering discipline and a minimum of six years of relevant industrial experiencePh.D. in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry or related life science or engineering discipline and a minimum of three years of relevant industrial experience
Required Experience and Skills:
Broader experience and knowledge in vaccine manufacturing process in the areas of upstream, downstream, drug product process, analytical, raw material, or packaging.Experience and knowledge in manufacturing process data and related analytics.Upstream and/or downstream bioprocessing experience (industry or academic).Passion for analyzing data and identifying opportunity for manufacturing process and productivity improvement.Experience and knowledge in tools such as Mantis, Dataiku, Pipeline Pilot, Werum MES, OSI Software PI, JMPStrong leadership skills.Strong problem-solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself.Strong technical ability in understanding complex investigation.Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications.A strong desire to succeed and to help others to do the same.Proficiency in the use of Microsoft Office Suite.Ability to travel up to 15%.
Preferred Experience and Skills:
Strongly preferred to have Fluency in Chinese both in technical translation and formal verbal and written communication, being able to represent our Company during the QN review meeting with China Agency.Experience in regulatory agency inspectionsBiologics, vaccine or sterile processingCross-functional project leadership
NOTICEFORINTERNALAPPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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, generally Tuesday, Wednesday and either Monday or 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 presence. This 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".
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$130,960.00 - $206,200.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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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:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R272512