Merck

Merck

Senior Specialist, Process Support Lab

USA - North Carolina - Durham (Old Oxford) · Senior · Contract

Sponsorship not specified$117k-$184kDetected 9 hours ago
Data AnalysisComplianceProcess ImprovementHRISGMPResearchExperimental DesignProtein AnalysisLeadershipCommunicationCollaborationMentoringWritingAdaptability

About the role

  • 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.
  • To be successful in this role, you will need to be an energetic, technical contributor with strong social, communication, partnership, and leadership skills.
  • 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.

Responsibilities

  • Manage PSL study leads on the team, specifically analytics team.
  • 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.
  • 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.
  • Lead technical, operational, and business system improvement projects.
  • 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.

Requirements

  • No Travel Required
  • Proven leader with demonstrated people management experience.
  • Prior experience with any of the following equipment ex: SoloVPE, Lighthouse, Cedex Bio, ViCell, UPLC, plate readers etc.
  • 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 candidate will be required to work in a fast-paced environment.
  • Required
  • 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.
  • Prior experience performing analytical assays (i.e. potency assays, serial dilutions, moisture testing, SDS-Page, dry weight, UV-Vis, BCA Assay).
  • 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.
  • Preferred
  • 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.

Nice to have

  • 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.
  • Experience using digital visualization tools (PowerBI, JMP, etc.).
  • Ability to provide scientific mentorship and guidance to technical colleagues.

Skills

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  • Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
  • For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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Compensation

  • The salary range for this role is

Benefits

  • We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.
  • shift or weekend coverage will occasionally be needed to assist the technical team, based on project-specific assignments and/or the vaccine production schedule.

Company info

  • Please click here if you need an accommodation during the application or hiring process.
  • As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
  • As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
  • For more information about personal rights under the U.S.
  • We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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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.
  • At our company, we aspire to be the premier research-intensive biopharmaceutical company.

Equal opportunity

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  • We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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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  • The salary range for this role is

Visa & Work Authorization

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