Job Description

GENERAL SUMMARY:

The Director, Technical Operations for the Barrier Operations IPT within the BBM E2E Technical Operations at the West Point site is responsible for the oversight of one or more technical teams. The primary responsibility of the Director is providing leadership and expertise in monitoring and improving production process performance, continuous improvement projects, process validation, sterilization and cleaning validation, change implementation, deviation investigations and CAPA implementation among other related duties. The Director will have overall responsibility for the performance and results of the technical operations team supporting the IPT. We seek someone that values diversity and inclusion for the Director of technical operations role.

GENERAL PROFILE:

• Builds talent by coaching and developing the members of the Technical Operations team to ensure appropriate breadth, depth and skill sets across the team to maintain and drive the business forward. Provides/solicits regular feedback from team and colleagues.

• Responsible for building/growing the organization's functional excellence. Recruit and direct engineers and scientists as necessary.

• Manages team resources and prioritizes as aligned with business needs to include run the business support, project support, and continuous improvement activities - e.g. improve safety/compliance, reduce cost and increase consistency and efficiency.

• 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 such as Operations, Technology, Quality, Automation, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements.

• Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions. Approves technical documentation including investigations, protocols, qualification, validation etc. as required. Responsible for presenting technical discussions to regulatory agencies during inspections.

• Adapts technical support model to address resource and operational challenges and evolving business needs.

• Responsible for the performance and results of the overall technical team

BUSINESS EXPERTISE:

• Applies management skills to align staff activities with department objectives.

FUNCTIONAL EXPERTISE:

• Work with a cross-functional team within the IPT consisting of Operations, Technology, Quality, Automation, and Regulatory team members, among others, to develop and maintain manufacturing processes that meet cGMP and business requirements.

• Utilize core technology principles to design, develop or maintain processes to clean, sterilize, and manufacture vaccine products.

• Develop technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstration, process change and/or validation.

• Assist with troubleshooting and effectively resolving problems. Develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent a recurrence.

• Ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.

• Provide leadership on schedule, priorities, and issue resolution to aid the team in accomplishing business objectives. Simplifies work to help team members maintain focus on critical priorities.

• Coordinate the work of the IPT technical team to identify and implement technology-driven productivity and cost improvements. Exhibit behaviors focused on equipment uptime, minimizing cost and maintaining process consistency.

• Takes a leadership role in regulatory inspection activities for the facility. Assist in authoring regulatory submissions and presenting work to multiple regulatory agencies throughout the inspection process.

• Responsible for building/growing the team's functional excellence. Recruit and direct engineers and scientists as necessary. Develops technical/professional staff through mentoring, assignment selection and training.

• Monitors the health of the process through continuous monitoring and the annual process review or continuing validation activities.

• Develops and assures consistent application of standardized work, engineering and process tools to monitor progress, ensure compliance and measure success.

• Links with key functional leads on site and above site to provide input on behalf of the site team.

PROBLEM SOLVING:

• Directs the resolution of complex technical or business problems.

• 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 decisionsand/or issues that impact other units with inter-related processes.

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; supports E2E technical lead in managing towards allocated budget.

Education Minimum Requirement:

• B.S. degree in Engineering or Sciences

Required Experience and Skills:

• Minimum 10 years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. / Ph.D. degree plus 6 years).

• Tech Ops experience in biologics, vaccine or bulk sterile manufacturing facilities.

• Minimum of 4 years of Management or Supervisory experience.

• Highly developed communication, leadership and teamwork skills.

• Experience leading and managing departmental or cross-functional teams.

• Regulatory inspection presentation experience with external regulatory authority representatives.

Preferred Experience and Skills:

• Experience in formulation and filling

• Advanced degree (M.S., PhD) in Engineering or Sciences and/or relevant work experience.

• Sterile manufacturing experience.

• Validation experience

Working Relationships:

• Reports to End-to-End Technical Operations Lead.

• Manages and interacts with employees within own organization.

• Frequent interaction with employees from other IPTs, sites and external suppliers

• Interacts with representatives from regulatory agencies.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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, 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".

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.

Requisition ID:R328033