Director, Technical Operations Laboratory Lead

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

At our Company campus in Elkton, Virginia, we currently have an opening for a Director which will head our Technical Operations Laboratory Function within the Technical Operations team. The manufacturing facility is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains a short distance from the University of Virginia and James Madison University.

A successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multi-disciplinary team supporting the operation of pharmaceutical, biopharmaceutical, vaccine product manufacturing facilities. The Director of Elkton’s Technical Operations Laboratories will oversee the process development laboratory and will lead a team of scientists and engineers at our Company’s Manufacturing site in Elkton, VA. This laboratory supports bioprocesses across the plant site and manufacturing networks including vaccine and potentially biologics manufacturing. Its focus is late-stage process development for in-line and pipeline products, as well as laboratory support for existing products to enable process optimization, troubleshooting and microbiology support. The Director of Technical Operations Laboratories The candidate will have in depth expertise of microbial fermentation, standard biochemical purification techniques and an ability to quickly adapt and respond to customer needs and challenges.

Position Responsibilities:

• guides the activities of, administratively manages, and develops a professional staff of ~30 full-time employees

• serve as the primary contact for the site for product development and commercialization teams

• Maintain excellence of compliance with safety and environmental regulations

• develop, commercialize and support new biologics and vaccine products at Elkton.

• establish and qualification of scale down models to support commercial scale process investigations

• late-stage process development and characterization

• partners with the commercial facilities to complete process descriptions, risk assessments and control strategies

• technology transfer or tech transfer support of the process to the commercial scale

• be externally recognized as a thought leader in vaccines and biologics commercialization and be able to adapt and respond to an ever-changing environment

Education Minimum Requirement:

• B.S. degree in microbiology, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of 12 years of relevant industrial experience

• M.S. degree in microbiology, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of 10 years of relevant industrial experience

• Ph.D. in microbiology, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and relevant industrial experience and a minimum of 8 years of relevant industrial experience

​Required Experience and Skills:

• Minimum of 8 years experience in large molecule (biologics and/or vaccines) process development.

• Minimum of 5 years of direct management experience.

• Large molecule (biologics and/or vaccines) process development and/or commercialization experience.

• Demonstrated scientific problem solving and bias toward going to see problems

• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.

• A strong desire to succeed and to help others to do the same.

Preferred Experience and Skills:

• Ph.D. in a relevant field

• Knowledgeable of cGMPs, financial principles, safety guidelines, engineering standards and regulatory challenges.

• Experience with lab, pilot and commercial scale process development

• Technology transfer, new asset realization and start-up experience.

• Demonstrated interpersonal skills including flexibility and ability to work in a team environment.

• Strong technical writing skills as demonstrated through publications, patents, internal technical memos and/or CTD sections of a regulatory filing.

• Technically proficient and has demonstrated managerial and leadership skills necessary to build and maintain a high-performing group of mutli-disciplinary technical professionals.

• Excellent organization and project management skills

• Participation in regulatory agency inspections

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

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.

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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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US and Puerto Rico Residents Only:

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R222980