Director, Engineering

Job Description

Manufacturing Support and Optimization (MSO) plays a crucial role within LM S&T-GSTS (Global Science Technology Services) by providing technical subject matter expertise support for vaccines and biologics products. 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 leveraging our unique experience and knowledge as subject matter experts.

The Director position will serve as one of our Vaccine Products China Tech lead. Working closely with the Technical Product Leadership (TPL), the candidate will be responsible for China-related technical issues, with a primary focus on three areas:

• Leading a specialized team to provide critical technical support for the China Agency QN (Quality Notice) review and approval as part of the vaccine batch release requirement in China. The goal is to achieve a "right first time" QN review to ensure the timely release of our vaccine products into the Chinese market. The candidate will collaborate closely with Site Tech Operation and Quality, Global Tech Operation and Quality, and China In Market Quality in QN review preparation. The specialized team will ensure technical accuracy in the QN and proper translation. The candidate will also conduct presentation mock runs with China In Market Quality and attend QN review meetings with the Chinese Agency as needed, following up on any questions raised during the review
• Serving as the Vaccine TPL representative on the HPV VCMT (Value Chain Management Team) China Subteam, providing technical support for China manufacturing supply strategy, including in-market testing and batch release. Supporting Vaccine China regulatory responses to ensure accurate technical information in the Chinese language version. Partnering with CMC (Chemistry, Manufacturing, and Controls) and key stakeholders in developing strategic responses for regulatory technical queries (RTQs) across all HPV China Health Authority submissions.
• Supporting the CFDI (China Food and Drug Inspection) inspection for Vaccines to ensure accurate translation during the site inspection and inspection responses. Participating in inspection preparation and readiness for complex manufacturing and/or laboratory investigations. Leading/participating in discussions between our Company and CFDI to ensure proper communication if required.

Position Responsibilities and Capabilities:

• Leading and managing a specialized and dedicated team of at least two members.
• Initiating and obtaining approval for the QN summary from the site IPT (Integrated Process Team).
• Providing technical expertise in assessing the QN.
• Ensuring accurate technical translation.
• Conducting mock runs to prepare the China In-Marketing team.
• Being present during the China Agency QN review.
• Responsible for QN follow-up questions.
• Serving as the Vaccine TPL representative on the HPV VCMT China Subteam.
• Supporting our Company's China manufacturing supply strategy, including in-market testing and batch release.
• Supporting Vaccine China regulatory responses and ensuring accurate technical information in the Chinese language version.
• Providing language and subject matter expert support for Vaccine-related process and product inquiries from the Chinese government.
• Supporting the CFDI inspection for Vaccines, including translation accuracy, inspection responses review, and participating in discussions with the CFDI.
• Supporting our Company's China Quality by providing consulting for addressing emerging issues and identifying trends in China's quality and compliance requirements.
• Owning and being accountable for China Vaccine Post-marketing Commitments in support of IDL (Initial Domestic License) Renewal.

Education Minimum Requirement:

• B.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, or related life science or engineering discipline, with a minimum of 12 years of relevant industrial experience.
• M.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, or related life science or engineering discipline, with a minimum of 10 years of relevant industrial experience.
• Ph.D. in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, or related life science or engineering discipline, with a minimum of 8 years of relevant industrial experience.

Required Experience and Skills:

• Broader experience and knowledge in vaccine manufacturing processes in areas such as upstream, downstream, drug product process, analytical, raw materials, or packaging. Vaccine manufacturing experience is preferred.
• Strong capability and demonstrated experience in vaccine manufacturing QN processes, including root cause investigation and impact assessment.
• Fluency in Chinese for technical translation and formal verbal and written communication, able to represent our Company during QN review meetings with the Chinese Agency.
• Strong leadership skills, with the ability to manage and mentor a small subject matter expert team.
• Strong technical ability to understand complex investigations.
• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills.
• Experience with regulatory agency inspections, particularly with Chinese Agency.

NOTICE FOR INTERNAL APPLICANTS

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 separation package, 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".

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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:

Relocation:

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Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/02/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R302873