Job Description

P2 : Process Support Lab Specialist

Job Description:

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company’s lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company’s Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years, as well as future anticipated growth as part of the new product vaccine tech transfers to the facility.

The Process Support Lab Associate Specialist will be an energetic, technical contributor with strong interpersonal, communication, and collaboration skills responsible for lab-scale vaccine process development execution, technical transfer support, and post commercial process enhancements activities for multiple pipeline vaccine programs. The well-qualified candidate must have analytical, problem-solving, and communication skills. Furthermore, the candidate will be required to work in a fast-paced environment. Off-shift or weekend coverage may occasionally be required to support the technical team, based on project-specific assignments and/or the vaccine production schedule.

Key responsibilities may include but are not limited to:

• Provide technical hands-on support in execution of lab-scale experiments in one of the following areas: (1) downstream processing including buffer preparation, benchtop homogenization, resin chromatography purification, and TFF/NFF operations, or (2) bio-analytical assays for in-process and post-processing samples (ie, SDS-PAGE, BCA Total Protein, UV/Vis, DLS, UPLC-SEC, SoloVPE, microbial growth).

• Serve as a study lead with responsibility for scheduling operations, leading experimental design planning, ordering materials, and overseeing experiment execution to ensure all activities are completed successfully.

• Provide technical leadership and team support in hands-on execution of lab-scale experiments and support assay qualifications or trouble-shooting of in-process assays in the tech transfer and manufacturing spaces.

• Lead in design, execution and data analysis for laboratory experiments. Scope of work may include supporting process characterization and commercial technology transfer associated with the development and implementation of the new vaccine processes, and as needed for investigational, developmental, or continuous improvement projects for our Company's existing Durham vaccine products.

• Troubleshoot equipment and assays as needed.

• Ability to support non-routine 2nd and 3rd shift work if needed based on experimental designs or customer needs.

• Author and present experimental design proposals, technical reports and documents to peers and stakeholders.

• Compile process data and employ statistical tools for experimental analysis and process monitoring.

• Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to vaccine processes.

Education Minimum Requirement:

• Bachelor’s Degree or higher in Engineering or Sciences, with relevant academic experience with at least two (2) years of relevant experience.

Required Experience and Skills:

• Strong leadership, interpersonal and communication skills (written and oral).

• Experience in vaccine or biologics processing, including either lab- or manufacturing- scale support in downstream or analytics.

Preferred Experience and Skills:

• Hands-on experience in large molecule purification (chromatography, filtration) or bio-analytical assays.

• Ability to drive studies and experiments in the context of a long-term commercialization plan.

• Ability to provide scientific mentorship and guidance to technical colleagues.

• Take lead in solving technical problems and equipment issues.

• Proficient using statistical tools (JMP or Minitab) for experimental design, data analysis and modeling.

• Experience with Design of Experiments (DOE).

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.

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.

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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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.

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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, generally Tuesday, Wednesday and either Monday or 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”.

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:

07/17/2024

*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.

Job Posting End Date:07/17/2024

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.

Requisition ID:R298091