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An Associate Director of Vaccine Manufacturing provides support and expertise to the Integrated Process Team in support of Vaccine 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
Competencies
Education Requirements
Experience and Skills
Preferred
#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
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, 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:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
An Associate Director of Vaccine Manufacturing provides support and expertise to the Integrated Process Team in support of Vaccine 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
- Direct the Integrated Process Team with comprehensive management of all activities required to successfully support Vaccine Manufacturing
- 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
- Implement Integrated Process Team plans and priorities based on division scorecard and yearly Hoshin Kanri
- Manage and forecast budget of Integrated Process Team
Competencies
- Technical expertise in vaccine production (antigen, formulation, fill, bioreactor/ SUB (single use bioreactors) bacterial fermentation, monoclonal antibodies, emulsification)
- Manages individual contributors (professional employees) and managers
- Proven people development and coaching skills
- Working knowledge of aseptic techniques and aseptic operations
- 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
- Excellent communication skills; able to communicate company and site strategies to direct reports and IPT employees
- 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
- Five (5) or more years relevant experience in the Vaccine Manufacturing/ operations 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
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, 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:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
