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AVP, Biologics Technical Operations
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Job Description
The Biologics Technical Operations lead, reporting to the Global Science, Engineering and Commercialization (GSEC) Large Molecules Technical Operations leader, will be accountable for providing technical support to our internal and external network of biologics sites (Drug Substance and Drug Product) for both commercial and pipeline products. The Biologics Technical Operations lead will partner closely with Biologics Manufacturing Operations leaders to ensure that technical support flowing into site Integrated Product Teams (IPTs) is aligned with the needs and expectations of each site and aligns with the overall strategy of creating an efficient, cost-effective supply for our portfolio of Biologics products. They will also partner closely with the Vaccines Technical Operations lead to enable shared learnings, integrated evolution of best practices, and leverage efficiencies across modalities. The individual biologics site technical operations/Manufacturing Science & Technology (MS&T) leaders will report into the Biologics Technical Operations lead.
In this role, the qualified candidate will be tasked with continuing to evolve the strategy and operating model for technical support in a manner that leverages the broader capability of the Large Molecules Science & Technology (S&T) network to drive for scientific excellence and efficiency, while maintaining clear accountability for robust performance across all Biologics products. This individual will bring a breadth of experience across different types of Biologics molecules to support the continued growth and evolution of our Biologics business. They will provide the necessary technical leadership, oversight and support for technology transfer of new and existing products across the entire Biologics portfolio, as well as provide in depth technical support and monitoring of established products across our network of sites and CMO partners. They will bring additional depth of experience and rigor to support right-first-time technology transfer, sustained robust process performance, and continuous improvement across our Biologics portfolio.
In addition to continuing to develop technical depth within this organization, the qualified candidate must have demonstrated ability to attract, coach and develop talent and to build an inclusive culture that leverages diverse talent to fully enable a high performing team and organization. They will create a highly collaborative and inclusive environment within the team and across the interconnected, interdependent global network for the all the areas of responsibilities within scope, demonstrating a boundaryless organizational mindset (right people, place, time). This includes personal engagement, sponsorship of active participation in management of knowledge, communities of practice, virtual technical network, product stewardship, technology platforms and best practices sharing across the broader Large Molecules organizations in the flow of the core work. They will also establish productive partnerships with Biologics Operations leadership to support seamless integration of Tech Ops/MS&T teams within each site, with a focus on delivering value.
Education:
Technical Competencies (Core S&T Functional Competencies):
Professional Competencies:
Business Acumen and Financial Management
Problem Solving/ Process Improvement
Project Management
Strategic Thinking and Working across Boundaries
Productive Communication
Leadership & Managerial:
Build Talent
People Management
Drive Results
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".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$268,500.00 - $422,700.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here .
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:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
11/7/2024
*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:R318932
The Biologics Technical Operations lead, reporting to the Global Science, Engineering and Commercialization (GSEC) Large Molecules Technical Operations leader, will be accountable for providing technical support to our internal and external network of biologics sites (Drug Substance and Drug Product) for both commercial and pipeline products. The Biologics Technical Operations lead will partner closely with Biologics Manufacturing Operations leaders to ensure that technical support flowing into site Integrated Product Teams (IPTs) is aligned with the needs and expectations of each site and aligns with the overall strategy of creating an efficient, cost-effective supply for our portfolio of Biologics products. They will also partner closely with the Vaccines Technical Operations lead to enable shared learnings, integrated evolution of best practices, and leverage efficiencies across modalities. The individual biologics site technical operations/Manufacturing Science & Technology (MS&T) leaders will report into the Biologics Technical Operations lead.
In this role, the qualified candidate will be tasked with continuing to evolve the strategy and operating model for technical support in a manner that leverages the broader capability of the Large Molecules Science & Technology (S&T) network to drive for scientific excellence and efficiency, while maintaining clear accountability for robust performance across all Biologics products. This individual will bring a breadth of experience across different types of Biologics molecules to support the continued growth and evolution of our Biologics business. They will provide the necessary technical leadership, oversight and support for technology transfer of new and existing products across the entire Biologics portfolio, as well as provide in depth technical support and monitoring of established products across our network of sites and CMO partners. They will bring additional depth of experience and rigor to support right-first-time technology transfer, sustained robust process performance, and continuous improvement across our Biologics portfolio.
In addition to continuing to develop technical depth within this organization, the qualified candidate must have demonstrated ability to attract, coach and develop talent and to build an inclusive culture that leverages diverse talent to fully enable a high performing team and organization. They will create a highly collaborative and inclusive environment within the team and across the interconnected, interdependent global network for the all the areas of responsibilities within scope, demonstrating a boundaryless organizational mindset (right people, place, time). This includes personal engagement, sponsorship of active participation in management of knowledge, communities of practice, virtual technical network, product stewardship, technology platforms and best practices sharing across the broader Large Molecules organizations in the flow of the core work. They will also establish productive partnerships with Biologics Operations leadership to support seamless integration of Tech Ops/MS&T teams within each site, with a focus on delivering value.
Education:
- BS, MS or PhD in Engineering, Pharmaceutics, Science or Equivalent and a minimum of 20 years' experience post BS.
Technical Competencies (Core S&T Functional Competencies):
- Technical Expertise in Biologics drug substance and drug product development and manufacturing
- External manufacturing experience
- Biologics DS (upstream, downstream) and DP knowledge and understanding
- Low bioburden and/or sterile processing expertise
- Process sciences laboratory management experience
- Demonstrated track record of applying scientific, technical knowledge and problem-solving approaches to deliver business results within a commercialization/ manufacturing environment
Professional Competencies:
Business Acumen and Financial Management
- In-depth knowledge of financial systems (budgets, expenses, product standards and variances.)
- Management of a large, agile organization with resources that include full time and temporary employees providing a pipeline of talent at the site and global levels.
- Understanding of cost levers across Tiers driving productivity at all levels.
Problem Solving/ Process Improvement
- Drive data driven outcomes in support of new, complex, or problematic situations; creates solutions that drive value for our company and our customers, incorporating innovative approaches.
- Drives technical excellence by modeling and teaching scientific problem-solving approaches to group and peers.
- Demonstrates a lean mindset and drives continuous improvement
- Demonstrated capability in establishing process stability in a challenging and complex scientific environment
Project Management
- Able to effectively manage complex organizations, and prioritize projects, programs and resources effectively, in alignment with business needs
Strategic Thinking and Working across Boundaries
- Embodies our company's mindset
- Engages partners and performs work with a service mindset
- Bridges boundaries across teams, functions, divisions, geographies, external stakeholders, and customers.
- Practices and sponsors Inclusive Behaviors and mindsets in the flow of work.
- Partners with site and global leaders to provide local SMEs to accelerate problem-solving and deliver critical business outcomes.
Productive Communication
- Plans and delivers ideas and information to others in a clear and impactful manner.
- Continuously communicates to align with partners and stakeholders
- Communicates effectively with direct reports and employees.
Leadership & Managerial:
Build Talent
- Build diverse talent within the workgroup with the capabilities necessary for future success.
- Continuously assesses competencies versus future needs and plan to fill gaps
- Reward and develop employees to ensure individuals reach their full potential
People Management
- Is an experienced Coach and teacher of people.
- Demonstrated application of culture and business change methodologies (CEM, Inclusion and BCCM) when realizing site and cross functional process improvement initiatives.
- Demonstrates Inclusion and our company's Enterprise Leadership Skills, including integrity, resilience, and flexibility.
Drive Results
- Sets clear performance standards including stretch goals for teams and organization
- Holds self and others accountable for achieving results
- Works proactively to remove barriers to achieving and exceeding goals.
- Communicates a sense of urgency, high performance bars and changes to deliverables in a timely manner with workgroup and stakeholders.
- Balances technical rigor and business outcomes effectively in solving problems
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".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$268,500.00 - $422,700.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here .
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:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
11/7/2024
*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:R318932
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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