工程高级总监
Associate Director, Engineering
**职位描述**
**总体概述：**
由于持续增长和投资，我们公司正在招聘一名**生物制品外部制造技术部高级总监**。
该高级总监将是公司与外部合作伙伴之间生物制品外部制造（ExM）组织的关键技术领导接口。
该职位将负责创建、领导并执行从外部合作伙伴处的技术转移和商业供应。候选人将位于美国西海岸，并向生物制品外部制造技术部总监汇报。
理想的候选人应能够在一个复杂的生物制品物质节点网络中进行导航，涵盖不同的生物制品模式和技术支持模型。候选人需要与多个技术职能协作，以确保与外部合作伙伴的技术转移和商业制造的成功。该职位能够领导多个高影响力、复杂且跨职能的部门团队，并为部门提供重要的领导力。该职位对组织支持新进和现有商业产品技术转移至外部合作伙伴，以及现有产品的支持能力至关重要，需具备敏锐的监督和专业技术风险管理能力，专注于快速扩展的生物制品第三方网络。
**职位简介：**
**生物制品外部制造技术部高级总监**负责在与内部技术合作伙伴及外部合作伙伴（EP）领导合作中实现合规性、供应、持续改进和成本降低方面的卓越表现，支持疫苗和生物制品业务。该职位与**聚焦工厂运营负责人**、**特定模态技术负责人**、**大分子外部质量保证**和**采购部门**紧密合作。高级总监必须具备生物制品制造经验，拥有广泛的工艺科学和分析知识，强大的领导能力、商业意识和人际交往能力。
**职位详情：**
高级总监的主要职责是为生物制品外部制造业务提供技术和项目领导：
- 为指定的外部合作伙伴、受影响的公司制造部门地点和商业化提供单一技术联系点。
- 为复杂的生产流程提供技术监督、管理和规划支持。
查看英文原文
**Job Description**
**General Summary:**
Due to continued growth and investment, our company is hiring an **Associate Director, Engineering within Biologics External Manufacturing Technology.**
The Associate Director will be the key technical leader interface between our company and External Partners for the Biologics External Manufacturing (ExM) organization.
This individual will create, lead and execute technical transfers to and commercial supply from External Partner(s). The candidate will be based in the US on the west coast and report to the Director, Biologics External Manufacturing Technology.
The ideal candidate will be someone who can navigate a complex network of drug substance nodes across biologics modalities and tech support models. The candidate needs to collaborate across multiple technical functions to ensure the success technical transfer and commercial manufacture with the External Partner(s). This individual will be capable of leading several high-impact, complex, cross-functional divisional teams and will provide significant leadership to the department. This role is critical to the organization’s ability to support new and in-line commercial product technology transfers to External Partnerships, and support of our in-line products, with sharp oversight and technical risk management, focus on the rapidly expanding biologics third party network.
**Position Profile:**
The **Associate Director, Engineering within Biologics External Manufacturing Technology** is accountable for achieving excellence in Compliance, Supply, Continuous Improvement & Cost Reduction in partnership with our internal technical partners and External Partner (EP) leadership, supporting the Vaccines and Biologics businesses. This individual works in collaboration with the Focus Factory Operations lead, modality specific Technology Leads, Large Molecule External Quality Assurance, and Procurement. The Associate Director must have biologics manufacturing experience, with broad process sciences and analytics, strong leadership skills, business acumen, and interpersonal skills.
**Job Details:**
The primary focus of the Associate Director is to provide technical and project leadership to Biologics External Manufacturing business for:
- Provides a single point of technical contact to assigned External Partners, impacted Company Manufacturing Division sites, and Commercialization.
- Provides technical oversight, management, and planning support for complex partnership models. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues
- Accountable to External Manufacturing for overall tech transfer delivery (on-time, within budget), working closely with the Operations Unit leadership to assure resourcing for each activity.
- Provides technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
- Collaborates with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate External Partner(s) for inclusion in the Company Network. Executes technical due diligence assessments at External Partner(s).
- Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.
- Leads team for identification and assessment of partner risks and develops mitigations plans.
- Develops and executes validation strategies for new and existing products.
- Provides manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
- Ensures targeted communications and alignment across technical functions. Guides and coaches' others in change leadership.
- Support/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites
- Determines resource plans across all relevant technical functions.
- Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes. Minimizes duplication of efforts between External Partner and Company systems.
- Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility
- In concert with Commercialization, Quality, and Regulatory, ensures that External Partner(s) are inspection ready for all new product introductions and transfers.
- Understands the true regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.
- Collaborates with External Partners to achieve business goals and to establish a common culture that benefits both Our Company and EP.
**Education Requirements:**
- A Bachelor’s degree in Engineering or applicable Science is required. An advanced degree in Engineering, Science, or Business is preferred.
- Minimum of 8 (eight) years post-bachelor’s degree experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing, engineering, and/or technical support of operations is required
**Skill Requirements:**
- Expertise and demonstrated accomplishments leading technical transfers is required
- Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s) is preferred
- Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements is preferred
- Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues is required
- Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) is required.
- Ability to motivate a team around a common vision and deliver expected results is preferred.
- Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and process troubleshooting is preferred
- Experience in complex international environment with matrix organization structures is preferred
- Experience in Large Molecule unit operation design, startup, and/or operation is preferred.
**Travel Requirements:** >30% for partner assignments outside of primary location (primarily traveling within designated EU region). Travel and flexibility in partner assignment location is required; assignments may require short term travel assignments.
**Location:** Location US is flexible. Position may be based in Northern California or our company's Sites in the US
**Reporting Structure:** This role will report to the Director, Biologics External Manufacturing Technology
**Required Skills:**
Adaptability, Automation Systems, Capital Project Management, Change Management, Clinical Manufacturing, Data Analysis, Decision Making, Drug Product Manufacturing, Interpersonal Relationships, Lean Manufacturing, Manufacturing Scale-Up, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Technical Transfer
**Preferred Skills:**
Current Employees apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please [click here](https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
[EEOC Know Your Rights](https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
[EEOC GINA Supplement](https://www.eeoc.gov/gina-genetic-information-nondiscrimination)
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
[Learn more about your rights, including under California, Colorado and other US State Acts](https://www.msdprivacy.com/us/en/CCPA-notice/)
The salary range for this role is
$142,400.00 - $224,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at [https://jobs.merck.com/us/en/compensation-and-benefits](https://jobs.merck.com/us/en/compensation-and-benefits).
You can apply for this role through [https://jobs.merck.com/us/en](https://jobs.merck.com/us/en) (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
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:**
Domestic
**VISA Sponsorship:**
No
**Travel Requirements:**
50%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
No
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
10/13/2026
***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.**