Senior Director, Biologics Strategy and Portfolio Management
Apply NowCompany: Merck & Co, Inc
Location: West Point, PA 19486
Description:
Job Description
The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new manufacturing technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.
We are seeking a highly motivated and experienced individual that will both tactically deliver key outcomes for the organization, and craft, refine, and execute on strategic initiatives to fully realize our business objectives. Applicants should have large molecule development and manufacturing experience with demonstrated capabilities across a background of diverse roles and functions. This individual will help oversee and manage the capital portfolio of BPR&D projects, global operations, and site master planning with both direct and matrixed team leadership. Additionally, this individual will be responsible for overseeing and managing the biologics program portfolio, providing greater coordination, insights, and transparency. The successful candidate will be leader who focuses on delivering executional excellence, is adept at navigating complex environments, and is experienced in driving global cross-functional collaboration towards shared business goals.
Job Responsibilities:
Education:
Preferred Education:
Required skills:
Preferred Experience and Skills:
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.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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".
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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
04/29/2025
*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.
The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new manufacturing technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.
We are seeking a highly motivated and experienced individual that will both tactically deliver key outcomes for the organization, and craft, refine, and execute on strategic initiatives to fully realize our business objectives. Applicants should have large molecule development and manufacturing experience with demonstrated capabilities across a background of diverse roles and functions. This individual will help oversee and manage the capital portfolio of BPR&D projects, global operations, and site master planning with both direct and matrixed team leadership. Additionally, this individual will be responsible for overseeing and managing the biologics program portfolio, providing greater coordination, insights, and transparency. The successful candidate will be leader who focuses on delivering executional excellence, is adept at navigating complex environments, and is experienced in driving global cross-functional collaboration towards shared business goals.
Job Responsibilities:
- Defines the strategy for capital and asset management across the organization globally, including both GMP and non GMP operations, facilities, laboratories, and office workspaces
- Responsible for operations portfolio management across the US workforce, including analysis and forecasting for headcount management and Long-Range Capital and Operations Plans (LRCP/LROP), and coordinate strategy with European colleagues for an integrated portfolio.
- Capital project owner of the new drug substance facility being built in Rahway, and responsible for delivering this asset while meeting all cost, schedule, and business requirements, and creating the pathway via teams and processes to a successful facility startup and future GMP operations
- Accountable for the new drug substance facility Operational Readiness, Strategy and Execution, including leading a matrixed team that will deliver the facility to ready for science.
- Work closely with the BPR&D leadership team to shape and execute strategy for biologics manufacturing network integration.
- Mentor and supervise junior colleagues; coach, and develop talent within the group, contribute to employee career development; build independent ownership and evolution of specializations within the team. Inspire, encourage and support scientific excellence
- Collate across the BPRD Network Operational Excellences and efficiency projects and partner with teams in driving their execution to deliver on BPRD objectives.
Education:
- Advanced degree (MBA, MS, MD, PhD or equivalent) required
Preferred Education:
- Ph.D. with 6+ years of industry experience or Masters with 10+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field
- Minimum of 10+ years of experience in operations/management, engineering, and/or capital delivery
Required skills:
- Knowledge of concepts and application of ISO, cGMP (CFR part 21/Annex 1 and 2), GDP, and data integrity expectations from regulatory agencies with large molecule drug substance development and production
- Knowledge of our company's Capital Management Process, Capital Team Leadership experience, continuous improvement, Lean, and Change Management skills, and demonstrated competency in business process improvement, capital planning, or project management
- Several years of experience with direct personnel management or leading large matrixed teams or projects
- Experience in both strategy development and tactical execution; taking an ambiguous concept, developing actions, and driving to completion
- Strong communications background with excellent verbal and written skills; ability to communicate effectively with senior management, peers, and direct reports across all levels of the business
Preferred Experience and Skills:
- Demonstrated ability to develop strong, trust based, collaborative relationships to drive change and execute on priorities with a diverse group of stakeholders
- Analytical mindset; comfortable working with data and making data-driven decisions across variety of technical subjects and backgrounds to achieve desired outcomes
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.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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".
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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
04/29/2025
*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.