Job Description
The Associate Director, Technical Operations, is responsible for the management and oversight of a team providing technical support for a live virus vaccine drug substance manufacturing facility at the West Point site. The primary responsibility of the individual will be leading the technical team in their 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, collaboration with the deviation management team and installation of robust CAPAs, among other related duties. The Associate Director will have overall responsibility for the performance and results of the technical operations team supporting the integrated production team (IPT). Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.
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GENERAL PROFILE:
- Builds talent by recruiting, 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. Develops technical/professional staff through coaching, assignment selection and associated training.
- Manages team resources and prioritizes in alignment with business needs including run the business support, project support, and continuous improvement activities - e.g. improve safety/compliance, reduce cost, and increase 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 such as Operations, Technology, Quality, Maintenance, Automation, Global Engineering Services, 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. Includes approval of technical documentation including investigations, protocols, qualification, validation etc. as required.
- Responsible for presenting technical discussions to regulatory agencies during inspections.
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 projects.
- Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.
- 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.
- Provides technical support to manufacturing for complex problems and issues.
- Coaches those providing technical support to manufacturing.
- Designs and conducts experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
- Authors and updates technical and manufacturing documents as necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
- Serve 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.
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
Minimum Education Requirement and Experience:
- Bachelor of Science (B.S.) degree in Engineering or Sciences with eight (8) years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations. OR
- Master of Science (M.S.) degree in Engineering or Sciences with six (6) years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations. OR
- PhD in Engineering or Sciences with four (4) years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations.
Required Experience and Skills:
- 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.
- Previous management or supervisory experience
- Sterile manufacturing experience.
- Validation experience
- Regulatory inspection presentation experience with external regulatory authority representatives.
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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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, 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".
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:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/6/2024
*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.
Job Posting End Date:10/06/2024
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:R314625