Our Biologics External Manufacturing network spans US, EU and AP, and includes the drug substance and drug product manufacture of biologics products.The Biologics External Manufacturing Technical Operations organization provides technical oversight to established commercial products and new product introductions within this complex network.The Biologics External Manufacturing (Bio ExM) Technical Operations lead, reporting to the Global Science, Engineering and Commercialization (GSEC) Biologics Technical Operations leader, will be accountable for managing this organization, and providing technical guidance and oversight to our external network of CMO partnerships supporting our portfolio of pipeline and commercial products (Drug Substance and Drug Product).
The qualified candidate will bring a passion for people development, a drive technical depth, and will maintain and expand collaborative partnerships with Operations, Quality and Commercialization partners to ensure that technical support flowing into established Virtual Focus Factories is aligned with the needs and expectations of each external site and aligns with the overall strategy of creating an efficient, robust, compliant, cost-effective supply for our portfolio of life saving products.
In this role, the qualified candidate will drive technical rigor and structured support for technology transfer of pipeline and in line products to new and established CMO partnerships, as well as provide in depth technical support to and monitoring of establish products across our network of CMO partnerships. They will bring practical experience and expertise across vaccines and biologics to support right-first-time technology transfer, efficient and effective resolution of complex investigations, sustained robust process performance, and continuous improvement. This individual will also be tasked with evolving the strategy and operating model for technical support in a manner that leverages the broader capability of our Biologics S&T network to drive for scientific excellence and efficiency, while maintaining clear accountability for robust performance across all Biologics CMO partners.
In addition to providing technical leadership, the qualified candidate will have a 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 foster 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).
Bachelor of Science (BS) Degree in life sciences or equivalent with ten (10) years of relevant biologics development, commercialization and/or operations experience
Master of Science (MS) Degree in life sciences or equivalent with eight (8) years of relevant biologics development, commercialization and/or operations experience
PhD in life sciences or equivalent with eight (8) years of relevant biologics development, commercialization and/or operations experience
Technical Expertise in the following areas: Biologics manufacture, Sterile manufacture, Engineering, and Process Engineering with a demonstrated track record of applying scientific, technical knowledge and problem-solving approaches to deliver business results.
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.
Creates awareness of cost levers across Tiers driving productivity at all levels.
Gathers and analyzes data and effectively responds to 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
Organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines and ensuring on-time delivery and right first time by integrating with partner areas.
Strategic Thinking and Working across Boundaries
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.
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.
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
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 Leadership behaviors, including integrity, resilience and flexibility.
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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.
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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”.
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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Originally posted on Himalayas
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