Associate Director, TT Systems Group Leader - West Point, United States - myGwork - LGBTQ+ Business Community

Description

Associate Director,

Technology Transfer

(TT)Systems Group Leader
As part of

ourManufacturingDivision , within Global Science Engineering & Commercialization, the Large Molecule Science and Technology (LMS&T) is accountable for Large Molecule Commercialization, Technical Product Leadership and Technical Operations.

We are seeking a highly motivated individual for the role of Associate Director,

Technology Transfer

(TT) Systems Group Leader in Large Molecule Technology Transfer within Technical Product Leadership. This role will lead a team of scientists and engineers with a focus on end-to-end technical transfer systems (Standards, Playbook, Portal, Project Management) for technology transfers to all large molecules in pipeline and inline space.
The incumbent will demonstrate a deep expertise for people management leadership and TT systems.

The incumbent will have broad, experience-based skillsets in TT Standards, TT best practices and TT Project Management with key focus on standards and right first-time success for commercial scale manufacturing sciences/technology and in applicable business processes including program/portfolio management tools working with internal and external manufacturing partners.

The incumbent will partner with groups across our Company and that includes the Global Human Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory-CMC, and Supply Chain.

Associate Director is expected to contribute to ongoing business process improvements and all TT activities.

Key Responsibilities:
Manages and accountable for the overall TT Systems (Standards, Playbook, Portal, Project Management) activities.
Ensures all TT systems are maintained and continuously improved with appropriate oversight.
Responsible to manage TT systems team. May act as one of the systems lead as well.
Accountable to build and maintain project schedules and critical project information, using project management tools.
Ensure clear and effective communication with key team, management, and cross-departmental stakeholders.

Coach and manage team dynamics, empower, and develop employees to understand all aspects of TT systems and coaches TT systems team for best practices and continuous improvement mindset.

Ensure TT leads and systems team connectivity. Responsible to ensure TT learnings are incorporated into standards.
Ensures TT project management tools are maintained and schedules are met and are on time. Help support the commercialization and TPL resource forecasting and headcount activities to support financial budgeting cycles and resourcing decisions.
Improving business processes to find new efficiencies and connect people to the information that they need.
Develop and maintain training programs related to TT systems.

Required to comply with our company Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

Work collaboratively to drive a safe and compliant culture.

Position Qualifications:
B.S. in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of 7 years of relevant experience.

Required Experience and Skills:

Technical Capabilities:
Expertise in technical aspects of product commercialization and life cycle management
Strong scientific knowledge of multiple TT types including vaccines / biologics drug substance, drug product and analytical.
Proficiency with validation section authoring and general BLA/MAA regulatory license documents.
Demonstrated creative problem-solving skill.
Strong knowledge of global regulatory guidelines and cGMP principles.
Demonstrated experience with lean operational excellence in manufacturing.
Digital tool competency with OnePMO, MS Teams, Power BI, MSPO, Spotfire, Share Points and other related systems.

Demonstrated ability to create and analyze detailed, cross-functional project plans (including Gantt charting) and manage execution and change against those plans.

Ability to identify and escalate TT systems risks.

Leadership / Business Capabilities:
Effective verbal and written communicator who keeps stakeholders / partners apprised of plans, status, and issues.
Works well in ambiguity.
Track record of motivating, mentoring and coaching teams.
Establishes clear goals, delegates effectively, holds self and others accountable.
Flexible and adaptable to dynamic situations.
Cross-functional team management; successful at indirect management.
Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.

Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas.

Well-developed and effective team facilitation and leadership skills; ability to establish inclusive team environments.
If youhavebeenofferedaseparationbenefitspackage,buthavenotyetreachedyour

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 foryourseparationbenefitspackage.
Todiscussinmoredetail,pleasecontactyour 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.

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:
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.
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

Job Description

Position Description:
Associate Director,

Technology Transfer

(TT)Systems Group Leader
As part of

ourManufacturingDivision , within Global Science Engineering & Commercialization, the Large Molecule Science and Technology (LMS&T) is accountable for Large Molecule Commercialization, Technical Product Leadership and Technical Operations.

We are seeking a highly motivated individual for the role of Associate Director,

Technology Transfer

(TT) Systems Group Leader in Large Molecule Technology Transfer within Technical Product Leadership. This role will lead a team of scientists and engineers with a focus on end-to-end technical transfer systems (Standards, Playbook, Portal, Project Management) for technology transfers to all large molecules in pipeline and inline space.
The incumbent will demonstrate a deep expertise for people management leadership and TT systems.

The incumbent will have broad, experience-based skillsets in TT Standards, TT best practices and TT Project Management with key focus on standards and right first-time success for commercial scale manufacturing sciences/technology and in applicable business processes including program/portfolio management tools working with internal and external manufacturing partners.

The incumbent will partner with groups across our Company and that includes the Global Human Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory-CMC, and Supply Chain.

Associate Director is expected to contribute to ongoing business process improvements and all TT activities.

Key Responsibilities:
Manages and accountable for the overall TT Systems (Standards, Playbook, Portal, Project Management) activities.

Ensures all TT systems are maintained and continuously improved with appropriate oversight.

Responsible to manage TT systems team. May act as one of the systems lead as well.

Accountable to build and maintain project schedules and critical project information, using project management tools.

Ensure clear and effective communication with key team, management, and cross-departmental stakeholders.

Coach and manage team dynamics, empower, and develop employees to understand all aspects of TT systems and coaches TT systems team for best practices and continuous improvement mindset.

Ensure TT leads and systems team connectivity. Responsible to ensure TT learnings are incorporated into standards.

Ensures TT project management tools are maintained and schedules are met and are on time. Help support the commercialization and TPL resource forecasting and headcount activities to support financial budgeting cycles and resourcing decisions.

Improving business processes to find new efficiencies and connect people to the information that they need.

Develop and maintain training programs related to TT systems.

Required to comply with our company Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

Work collaboratively to drive a safe and compliant culture.


Position Qualifications:

Education Minimum Requirement:
B.S. in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of 7 years of relevant experience.


Required Experience and Skills:

Technical Capabilities:
Expertise in technical aspects of product commercialization and life cycle management

Strong scientific knowledge of multiple TT types including vaccines / biologics drug substance, drug product and analytical.

Proficiency with validation section authoring and general BLA/MAA regulatory license documents.

Demonstrated creative problem-solving skill.

Strong knowledge of global regulatory guidelines and cGMP principles.

Demonstrated experience with lean operational excellence in manufacturing.

Digital tool competency with OnePMO, MS Teams, Power BI, MSPO, Spotfire, Share Points and other related systems.

Demonstrated ability to create and analyze detailed, cross-functional project plans (including Gantt charting) and manage execution and change against those plans.

Ability to identify and escalate TT systems risks.


Leadership / Business Capabilities:
Effective verbal and written communicator who keeps stakeholders / partners apprised of plans, status, and issues.

Works well in ambiguity.

Track record of motivating, mentoring and coaching teams.

Establishes clear goals, delegates effectively, holds self and others accountable.

Flexible and adaptable to dynamic situations.

Cross-functional team management; successful at indirect management.

Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.

Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas.

Well-developed and effective team facilitation and leadership skills; ability to establish inclusive team environments.


NOTICE

FOR

INTERNAL

APPLICANTS
Inaccordancewith

Managers'Policy-JobPostingandEmployeePlacement,

allemployees

subject

to

this

policy

are

required

to

have

a

minimum

of

twelve

(12)

months

of

service

in

current

positionprior toapplyingfor openpositions.
If youhavebeenofferedaseparationbenefitspackage,buthavenotyetreachedyour

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 foryourseparationbenefitspackage.
Todiscussinmoredetail,pleasecontactyour 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:
Yes


Travel Requirements:
25%


Flexible Work Arrangements:
Hybrid


Shift:
Not Indicated


Valid Driving License:
No


Hazardous Material(s):
n/a


Job Posting End Date:
05/31/2024

*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:
05/31/2024

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
BEFOREthe job posting end date.


Requisition ID:
R293527

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