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Associate Director, Manufacturing Operations
Associate Director, Manufacturing Operations-September 2024
De Soto
Sep 21, 2024
ABOUT MERCK
Merck enables a safe, sustainable and healthy future for people and communities everywhere...
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Healthcare
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About Associate Director, Manufacturing Operations

  Job Description

  An Associate Director of Manufacturing Operations provides support and expertise to the Integrated Process Team in support of manufacturing and distribution. The individual collaborates with appropriate internal and external partners to ensure the Integrated Process Team actions meet or exceed regulatory and company standards. There is collaboration with site leadership to determine optimum systems and processes leading to stable and effective results. The Associate Director directs teams to ensure business goals and budgets expectations are met and leads by example and displays strong coaching, Company Production Systems (CPS) principles, inclusive behaviors and best practices.

  The position will manage the activities within the Integrated Process Team and collaborate with Regulatory Affairs, Quality, Environmental Health and Safety, Engineering and Human Resources.

  Responsibilities

  Essential Functions

  Specific to Integrated Process Team responsibility for comprehensive management of all activities required to successfully support and manufacture product

  Performance manage individual contributors and managers

  Ensure compliance to corporate, site and departmental procedures associated with the manufacturing of product, and ensuring team is trained on new or revised processes or procedures

  Review and approve Quality Notifications

  Author, review and approve SOPs

  Serve as subject matter expert for product release matters

  Lead and/or participate in project management initiatives as appropriate to Integrated Process Team

  Direct support of regulatory inspections and audits

  Direct support of validation activities and all other associated Quality related activities pertaining to the Integrated Process Team

  Identify and resolve technical and operational issues; collaborate with others to resolve issues

  Accountable for overall performance of Integrated Process Team

  Implement Integrated Process Team plans and priorities based on division scorecard and yearly Hoshin Kanri

  Manage and forecast budget of Integrated Process Team

  Competencies

  Manages individual contributors (professional employees) and/or managers

  Contributes to the performance results of a department

  Adapts departmental plans and priorities to address resource and operational opportunities

  Decisions are guided by policies, procedures and business plan

  Provides technical guidance to employees, colleagues or clients

  Anticipates and interprets client and/or customer needs to identify solutions

  Proven ability to use scientific problem solving and lean manufacturing principles to solve complex issues

  Working knowledge of regulatory requirements in accordance with cGMP and/or USDA manufacturing operations

  Proven project management skills

  Proven people development and coaching skills

  Excellent communication skills; able to communicate company and site strategies to direct reports and IPT employees

  Working knowledge of aseptic techniques and aseptic operations

  Working knowledge of steam in place, clean in place, clean out of place and steam out of place

  Working knowledge of vaccine production (antigen, formulation, fill, freeze-drying, emulsification)

  Proficiency in computer systems and applications

  Must be able to lead in a team-based empowered culture

  Ability to work freely and effectively with peers; display strong interpersonal and organizational skills

  Knowledge and the ability to coach Lean methodology

  Education Requirements

  Bachelor's degree in Life Science, Engineering or related field of study.Experience and Skills

  Eight (8) or more years relevant experience in the vaccine and/or pharmaceutical/biotech industry

  Three (3) or more years of supervisory/ management (people, budget, organization and results) experience or equivalent.

  Strategic and effective Team building skills that focus on mentoring and coaching

  Positive and effective communication skills

  Demonstration of high analytical and logical problem-solving abilities

  Working knowledge of aseptic techniques

  Strong knowledge of manufacturing principles and operating systems

  Preferred

  SAP and inventory control

  LSS Green Belt or higher (LL2/LL3)

  Knowledge of 8-Step Problem Solving, Kata and other lean coaching tools

  #EBRG

  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.

  Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.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.

  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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

  EEOC GINA Supplement​

  Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

  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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

  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:

  Shift:

  Not Indicated

  Valid Driving License:

  No

  Hazardous Material(s):

  n/a

  Requisition ID: R273792

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