at Merck in De Soto, Kansas, United States
Job Description
Job Description
For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.
Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.
Join our Analytical Technical Solutions (ATS) team as a Specialist providing analytical support assisting in the critical production of veterinary large molecule biotherapeutics. This role involves working in regulated and/or non-regulated environment performing and supporting method development, validation and transfer activities from R&D to QC, from external sites or site-to-site. You will work with a variety of technical equipment independently or under moderate supervision, ensuring highest standards of safety and quality. The position can be based either in Millsboro, Delaware or De Soto, Kansas.
Key Responsibilities:
+ Develop, validate and transfer of phase-appropriate analytical methods for characterization and release testing of Large Molecule drug substances and drug products.
+ Conduct HPLC based method development for characterization of biologics (may include, charge particle analysis, reduced mass etc.) to provide better understanding of biologics attributes.
+ Interface with collaborators, CROs and CDMOs to facilitate method development, validation and transfer activities.
+ Author, review and approve test procedures, protocols, and reports.
+ May serve as a SME and aid in investigation of deviations, OOS and OOT analytical results
+ Plan, execute, document and data analysis and present results.
+ Troubleshoot and maintain lab instruments including but not limited to UPLC, LC-MS, particle counter, nanodrop etc. ensuring they remain in peak operational condition.
+ Additional tasks as assigned.
Required Education, Qualifications and Skills:
+ Bachelor’s degree in Life Sciences, Biology, Pharmaceutical Sciences or related fields with 3+ years of experience in biotech or pharma industry.
+ Prior hands-on experience in analytical method development for large molecules or proteins/monoclonal antibodies preferred.
+ Knowledge of method development and characterization of protein therapeutics using various analytical techniques, including liquid chromatography (HPLC/UPLC/FPLC, size exclusion chromatography, LC-MS), SDS-PAGE, Western blot, UV-Vis spectrophotometry, particle size by DLS or equivalent and capillary electrophoresis (CE-SDS). ELISA, cell based, viral assays (TCID50, plaque assay, neutralization assays) and/or molecular biology experience are a plus.
+ Familiarity with regulatory (GMP, USDA, FDA, ICH) guidelines and industry best practices. Experience working with veterinary products is a plus.
+ Understanding of statistical evaluation of analytical data and familiarity in Empower, Chromeleon, OpenLab ChemStation or equivalent data acquisition and processing software.
+ Ability to multitask and work in a fast-paced environment.
+ Good attention to detail and ability to thoroughly document experiments, data, technical reports and findings electronically in an accessible manner with good documentation practices.
+ Familiarity with standard office software (MS Office, Teams, SharePoint, excel, PowerPoint etc.)
+ The candidate should be self-motivated, accountable and possess excellent organization skills.
+ Ability to follow Global Health, Safety and Environment guidelines while performing routine tasks upholding our company’s commitment to “Safety First, Quality Always”.
Required Skills:
Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Biopharmaceuticals, Biopharmaceutics, Cell-Based Assays, Dissolution Testing, Driving Continuous Improvement, General Safety, Global Health, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Life Science, Microbiological Analysis, Microbiological Test, Molecular Biology, Multitasking, Self Motivation, Size Exclusion Chromatography (SEC), Teamwork, Technical Writing, Troubleshooting {+ 1 more}
Preferred Skills:
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
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 (https://survey.sogosurvey.com/r/aCdfqL) 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. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf)
EEOC GINA Supplement?
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.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
The salary range for this role is
$87,300.00 – $137,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: 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
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 u
To view full details and how to apply, please login or create a Job Seeker account