Senior Specialist, Process Support Lab

Merck•Durham, NC

1d•$117,000 - $184,200•Onsite

About The Position

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. The Maurice R. Hilleman Center for Vaccine Manufacturing, located in Durham, NC, is a state-of-the-art facility established in 2004 that 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 at the Durham site is seeking a Senior Specialist with outstanding interpersonal, communication, and collaboration skills. The PSL Senior Specialist will be responsible for participating in lab execution as well as leading a team of scientists and engineers that are study leads for analytical projects. The candidate must have demonstrated people management skills, as well as ability to support and mentor others on data analysis, technical writing, and lab execution / operations. The Senior Specialist will be responsible for leading and/or supporting their team to lead various experiments in lab-scale vaccine process development, technical transfer support, and post commercial process enhancements activities for multiple pipeline vaccine programs as needed based on our dynamic project portfolio. To be successful in this role, you will need to be an energetic, technical contributor with strong social, communication, partnership, and leadership skills. The candidate will be required to work in a fast-paced environment. Off-shift or weekend coverage will occasionally be needed to assist the technical team, based on project-specific assignments and/or the vaccine production schedule.

Requirements

Bachelor's degree in Engineering, Science or related discipline with a minimum of five (5) years of required experience in vaccine or biologics manufacturing within an aseptic, cGMP environment, OR Master's degree with a minimum of three (3) years of required experience OR Ph.D. with relevant academic experience.
Proven leader with demonstrated people management experience.
Prior experience performing analytical assays (i.e. potency assays, serial dilutions, moisture testing, SDS-Page, dry weight, UV-Vis, BCA Assay).
Prior experience with any of the following equipment ex: SoloVPE, Lighthouse, Cedex Bio, ViCell, UPLC, plate readers etc.
Proficient using statistical tools (JMP or Minitab) for experimental design, data analysis and control chart trending.
Experience in vaccine or biologics processing, including either lab- or manufacturing-scale support in analytics.
Experience authoring technical documentation within a cGMP context.
Proven technical communication (written & presentation) skills.
Strategic plan development and management.
Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.

Nice To Haves

cGMP manufacturing or Quality Operations support including providing immediate responses on the shop floor to deviations and potential deviations.
Ability to drive studies and experiments in the context of a long-term commercialization plan.
Design of Experiment (DOE) and One Factor at a Time (OFAT) experimental design.
Experience authoring technical documents supporting regulatory filings (IND, BLA).
Experience using digital visualization tools (PowerBI, JMP, etc.).
Ability to provide scientific mentorship and guidance to technical colleagues.

Responsibilities

Manage PSL study leads on the team, specifically analytics team.
Serve as a team Subject Matter Expert (SME) in technical data analysis. Leverage these skills to serve as a mentor in up-skilling and supporting peers in statistical tool and graphing techniques for experimental design, analysis, and process monitoring of manufacturing and Quality Operations testing, as needed.
Provide technical review and/or approval of PSL team experimental design proposals, analysis, technical protocols and reports.
Leverage various technical background (upstream, downstream, drug product, analytical) to lead and support late-stage process development, scale-down model development/execution/implementation, process characterization, commercial technology transfer, and qualification studies.
Support workstreams associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and drug product.
Execute bio-analytical assays for in-process and post-process samples, and support assay qualifications or trouble-shooting of in-process assays in the tech transfer and manufacturing spaces.
Execute experimental studies as needed for investigational, developmental, or continuous improvement projects for our Company's existing Durham vaccine products.
Assist in design and execution of lab experiments to support process characterization, commercial technology transfer, and qualification studies associated with the development and implementation of bulk processes, systems and facilities related to pipeline vaccine bulk products.
Actively participate on cross-functional teams to advance project goals and deliverables related to vaccine processes or analytics.
Lead technical, operational, and business system improvement projects.
Provide SME knowledge for manufacturing investigations (Product, process, and testing deviations).