Merck
Overview
Job Description The Associate Director, Technical Operations, is responsible for the management and oversight of the technical support teams for the MMR Bulk team within the Live Viral Vaccine End-to-End, at the West Point site. The primary responsibility is leading the technical team in support of run the business activities that include executing and directing production process performance, operations support, process validation, cleaning and sterilization validation activities, equipment/automation troubleshooting, implementation of process/equipment/analytical changes, oversight of the deviation management team and installation of robust CAPAs, among other related duties. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. General Profile Builds talent by coaching and developing the Technical Operations team to ensure appropriate breadth, depth and skill sets across the team to drive the business forward. Provides and solicits regular feedback from team and colleagues. Develops technical/professional staff through coaching, assignment selection and training.
Responsible for building and growing the organization’s functional excellence. Recruit and direct engineers and scientists as necessary. Develops technical/professional staff through mentoring, assignment selection and training.
Manages team resources and prioritizes as aligned with business needs to include run the business support, project support, and continuous improvement activities such as improving safety/compliance, reducing cost and increasing consistency and efficiency.
Provides leadership on schedule, priorities and issue resolution to aid the team in accomplishing business objectives.
Adapts and implements departmental plans and priorities based on-site and End-to-End scorecard to address local business, service and operational challenges.
Collaborates and engages with multiple functional organizations to develop and maintain processes that meet cGMP and business requirements, including Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others.
Provides technical guidance to staff and anticipates customer needs to identify solutions. Reviews and approves technical documentation including investigations, protocols, qualification, validation, etc., as required. Responsible for presenting technical discussions to regulatory agencies during inspections.
Business Expertise Applies management skills to align staff activities with department objectives.
Functional Expertise Coaches, manages, and develops a team of engineers through a direct reporting relationship. Recruits and hires engineers and scientists to support manufacturing operations.
Leads and/or coaches employees on complex manufacturing investigations and process improvement projects.
Analyzes issues from multiple perspectives (safety, compliance, automation, equipment, process, people) to identify root causes.
Monitors process health through continuous monitoring and the annual process review or continuing validation activities.
Develops and ensures consistent application of standardized work, engineering and process tools.
Provides technical support to manufacturing for complex problems and issues.
Coaches those providing technical support to manufacturing.
Designs and conducts experimental protocols using Technical Operations lab facilities and/or production equipment at full scale.
Authors and updates technical and manufacturing documents for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
Serves 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.
Takes a leadership role in regulatory inspection activities for the facility.
Problem Solving Identifies and resolves technical and operational problems using lean/six sigma tools.
Effectively collaborates with peers on site and above site as required.
Expert application of problem-solving skills.
Impact Influence Explains difficult concepts and persuades others to adopt point of view.
Communicates information, asks questions and checks for understanding.
Accountability Accountable for the performance of work group.
Decision Making Makes decisions guided by policies, procedures and department objectives.
Consults on an as-needed basis with next-level manager on more complex decisions.
Strategic Planning Adapts and implements departmental plans and priorities based on department and site scorecard to address local business, service and operational challenges.
Resource Management Forecasts resource needs; manages allocated budget.
Education Minimum Requirement B.S. degree in Engineering or Sciences.
Required Experience and Skills Minimum 8 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or PhD degree plus 6 years).
Minimum two years of Management or Supervisory experience.
Experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role.
Highly developed communication, leadership and teamwork skills.
Experience leading and managing departmental or cross-functional teams.
Preferred Experience and Skills Advanced degree (M.S., PhD) in science or engineering.
Sterile manufacturing experience.
Validation experience.
Six Sigma certification.
Regulatory inspection presentation experience with external regulatory authority representatives.
Working Relationships Reports to Technical Operations Director.
Manages employees within own department.
Interacts with employees within own department and from other departments.
Interacts with representatives from regulatory agencies.
Interacts with external suppliers.
Current Employees apply here Current Contingent Workers apply here 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 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 EEOC GINA Supplement 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 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, with Friday remote, unless business critical tasks require on-site presence. This model does not apply to field-based positions, facility-based roles, roles under a collective-bargaining agreement, or positions where remote work is not reasonably met. This guidance does not apply to roles designated as remote. The salary range for this role is $139,600.00 - $219,700.00. 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 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, retirement benefits including 401(k), paid holidays, vacation, and sick days. More information about benefits is available at the company benefits page. You can apply for this role through the company careers page or via 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 all qualified applicants, including those with criminal histories, in a manner consistent with 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. does not accept unsolicited assistance from search firms for employment opportunities. All CVs submitted without a valid written agreement will be the property of the company. No fee will be paid if hired through an agency referral without an agreement. Please, no phone calls or emails. Employee Status:
Regular Relocation:
Domestic VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Hybrid Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
n/a Required Skills:
API Manufacturing, Change Control Systems, Cross-Functional Teamwork, Equipment Qualification, Manufacturing Process Validation, People Leadership, Process Optimization, Regulatory Inspections, Regulatory Requirements, Strategic Thinking, Technical Guidance, Technology Transfer Preferred Skills: Job Posting End Date:
09/18/2025 *A job posting is effective until 11:59:59PM on the day before the listed job posting end date.
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Job Description The Associate Director, Technical Operations, is responsible for the management and oversight of the technical support teams for the MMR Bulk team within the Live Viral Vaccine End-to-End, at the West Point site. The primary responsibility is leading the technical team in support of run the business activities that include executing and directing production process performance, operations support, process validation, cleaning and sterilization validation activities, equipment/automation troubleshooting, implementation of process/equipment/analytical changes, oversight of the deviation management team and installation of robust CAPAs, among other related duties. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. General Profile Builds talent by coaching and developing the Technical Operations team to ensure appropriate breadth, depth and skill sets across the team to drive the business forward. Provides and solicits regular feedback from team and colleagues. Develops technical/professional staff through coaching, assignment selection and training.
Responsible for building and growing the organization’s functional excellence. Recruit and direct engineers and scientists as necessary. Develops technical/professional staff through mentoring, assignment selection and training.
Manages team resources and prioritizes as aligned with business needs to include run the business support, project support, and continuous improvement activities such as improving safety/compliance, reducing cost and increasing consistency and efficiency.
Provides leadership on schedule, priorities and issue resolution to aid the team in accomplishing business objectives.
Adapts and implements departmental plans and priorities based on-site and End-to-End scorecard to address local business, service and operational challenges.
Collaborates and engages with multiple functional organizations to develop and maintain processes that meet cGMP and business requirements, including Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others.
Provides technical guidance to staff and anticipates customer needs to identify solutions. Reviews and approves technical documentation including investigations, protocols, qualification, validation, etc., as required. Responsible for presenting technical discussions to regulatory agencies during inspections.
Business Expertise Applies management skills to align staff activities with department objectives.
Functional Expertise Coaches, manages, and develops a team of engineers through a direct reporting relationship. Recruits and hires engineers and scientists to support manufacturing operations.
Leads and/or coaches employees on complex manufacturing investigations and process improvement projects.
Analyzes issues from multiple perspectives (safety, compliance, automation, equipment, process, people) to identify root causes.
Monitors process health through continuous monitoring and the annual process review or continuing validation activities.
Develops and ensures consistent application of standardized work, engineering and process tools.
Provides technical support to manufacturing for complex problems and issues.
Coaches those providing technical support to manufacturing.
Designs and conducts experimental protocols using Technical Operations lab facilities and/or production equipment at full scale.
Authors and updates technical and manufacturing documents for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
Serves 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.
Takes a leadership role in regulatory inspection activities for the facility.
Problem Solving Identifies and resolves technical and operational problems using lean/six sigma tools.
Effectively collaborates with peers on site and above site as required.
Expert application of problem-solving skills.
Impact Influence Explains difficult concepts and persuades others to adopt point of view.
Communicates information, asks questions and checks for understanding.
Accountability Accountable for the performance of work group.
Decision Making Makes decisions guided by policies, procedures and department objectives.
Consults on an as-needed basis with next-level manager on more complex decisions.
Strategic Planning Adapts and implements departmental plans and priorities based on department and site scorecard to address local business, service and operational challenges.
Resource Management Forecasts resource needs; manages allocated budget.
Education Minimum Requirement B.S. degree in Engineering or Sciences.
Required Experience and Skills Minimum 8 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or PhD degree plus 6 years).
Minimum two years of Management or Supervisory experience.
Experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role.
Highly developed communication, leadership and teamwork skills.
Experience leading and managing departmental or cross-functional teams.
Preferred Experience and Skills Advanced degree (M.S., PhD) in science or engineering.
Sterile manufacturing experience.
Validation experience.
Six Sigma certification.
Regulatory inspection presentation experience with external regulatory authority representatives.
Working Relationships Reports to Technical Operations Director.
Manages employees within own department.
Interacts with employees within own department and from other departments.
Interacts with representatives from regulatory agencies.
Interacts with external suppliers.
Current Employees apply here Current Contingent Workers apply here 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 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 EEOC GINA Supplement 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 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, with Friday remote, unless business critical tasks require on-site presence. This model does not apply to field-based positions, facility-based roles, roles under a collective-bargaining agreement, or positions where remote work is not reasonably met. This guidance does not apply to roles designated as remote. The salary range for this role is $139,600.00 - $219,700.00. 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 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, retirement benefits including 401(k), paid holidays, vacation, and sick days. More information about benefits is available at the company benefits page. You can apply for this role through the company careers page or via 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 all qualified applicants, including those with criminal histories, in a manner consistent with 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. does not accept unsolicited assistance from search firms for employment opportunities. All CVs submitted without a valid written agreement will be the property of the company. No fee will be paid if hired through an agency referral without an agreement. Please, no phone calls or emails. Employee Status:
Regular Relocation:
Domestic VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Hybrid Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
n/a Required Skills:
API Manufacturing, Change Control Systems, Cross-Functional Teamwork, Equipment Qualification, Manufacturing Process Validation, People Leadership, Process Optimization, Regulatory Inspections, Regulatory Requirements, Strategic Thinking, Technical Guidance, Technology Transfer Preferred Skills: Job Posting End Date:
09/18/2025 *A job posting is effective until 11:59:59PM on the day before the listed job posting end date.
#J-18808-Ljbffr