US Regional Technology Transfer Lead, Director (Hybrid)

at Merck in Millsboro, Delaware, United States

Job Description

Job Description

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.



In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your 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 for your separation benefits package. To discuss in more detail, please contact your 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.

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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:

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Job Posting: JC258175809

Posted On: Apr 11, 2024

Updated On: Apr 28, 2024

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