US Regional Technology Transfer Lead, Director (Hybrid)
Merck - Omaha, NE, United StatesWork at Merck
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Overview
Merck US Regional Technology Transfer Lead, Director (Hybrid) Elkhorn , Nebraska Apply Now
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
The US regional technology transfer lead is accountable for successful process & analytical transfer, facility start-up, process validation, and knowledge management between 5 sites across the US region. The role reports to the Americas Biotechnology Support Lead with dotted-line accountability to the regional plant manager(s), where appropriate. The US regional technology transfer lead will be responsible for building a high-performing team to deliver process and analytical technology transfer to multiple products and processes across multiple manufacturing facilities. This role requires heavy collaboration across the franchise for collective success, including quality, operations, engineering, supply chain, regulatory/CMC, commercial, and other manufacturing network sites.
Job Responsibilities:
Supply – Accountable for on-time, right-first-time technology transfer of processes and products across drug substance and drug product. Collaborates with partner groups (operations, quality, regulatory, etc) to ensure file/launch on time. Drives development and delivery of pre-aligned criteria for process robustness (e.g. standard yield, batch discard rate, etc). Accountable for technology support and continuous process improvement for launch + 2 years.
Technical Excellence – Accountable for data-driven decision making across technology transfers. Drives continuous process improvements when required to enhance process or analytical robustness and/or decrease cost-of-goods (COGs). Oversees appropriate risk identification and mitigation methodologies (e.g. FMEA) to drive decisions. Manages technical stage-gate reviews, where appropriate. When needed, accountable for driving execution of appropriate lab experiments to reduce risk, increase robustness, or reduce COGs.
People Management – Accountable for building and sustaining a highly engaged technology transfer team through utilization of our Ways of Working. Drives culture of culture of safety, compliance, technical excellence, and employee development. Directly manages and coaches the technology transfer team. Provides team members with aligned objectives, regular feedback on performance (including soliciting stakeholder feedback), development conversations and career progression opportunities. Proactively engages in talent management, retention, and succession planning.
Strategic Leadership – Accountable for defining strategic direction and overseeing execution by the technology transfer team. Additionally acts as a key contributor to the Regional Technology Hoshin by aligning goals with external stakeholder groups and peer groups within the technology organization. Manages a portfolio of strategic initiatives.
Required Education & Experience:
Bachelor of Science in Chemical Engineering, Biotechnology, Mechanical Engineering, Biochemistry, Protein Chemistry, Veterinary Science or related field
Bachelors degree with at least (10) years of relevant work experience in vaccine and/or biopharmaceutical technical functions, such as process development/characterization, validation, technology transfer, and/or technical operations
Or Masters degree and at least (5) years of relevant experience
Or a Doctoral degree with at least (3) years of relevant experience
Required Qualifications:
Minimum of (3) years of direct management experience
Demonstrated experience with USDA regulations, FDA, and/or EMA pharmaceutical regulations
Demonstrated commitment to Diversity, Equity, & Inclusion
Preferred Qualifications:
Demonstrated experience in commercial biomanufacturing (sterile/aseptic, bulk drug substance, filling, lyophilization, etc.) in a regulated environment
Demonstrated experience in working with USDA Animal Health products
Demonstrated ability to create an engaged workforce aligned with company values and Ways of Working
Demonstrated experience of interacting with regulatory agencies via on-site inspections
Demonstrated successes with Talent Management, reorganization, and strategic initiatives
Demonstrated experience with statistical process control and/or design of experiments
Disclaimer: This is a general description of the principal job responsibilities. It is not meant to be comprehensive. Roles may be refined and/or additional responsibilities may be assigned, depending on temporary or permanent business changes/needs.
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Expected salary range:
$164,800.00 - $259,400.00
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