MSD
Job Description
Scientist (R2) Biologics Analytical
North American GMP Operations, Rahway, NJ
We invite individuals who possess a deep passion for promoting lifesaving and life-enhancing products to join our dynamic team. Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our company's extensive range of products from candidate selection to market authorization.
We are actively seeking an enthusiastic individual to join our Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D) GMP Operations, to support separations methods (e.g. HPLC, UPLC, CE, iCIEF). In this role, the selected candidate will be responsible for method optimization, phase-appropriate validation, early and late-stage analytical transfers, analytical life cycle management, and release and stability testing.
The incumbent will collaborate closely with various stakeholders, including Analytical Development, External Capabilities, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically sound guidance at each stage of development, and effectively manage deliverables to progress the pipeline.
Responsibilities
Validate and implement analytical methods to support release and stability testing of clinical materials. Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP). Act as subject matter expert (SME) across various franchises and analytical platforms. Support biologics registrations, product launches, and troubleshooting activities. Support compliance audits, inspection activities, and investigation/CAPAs. Author and review technical documents. Complete assigned work within established project timelines. Ensure adherence to GMP standards and facilitate ongoing enhancement of laboratory processes. Manage laboratory equipment, laboratory supplies and critical reagent inventories. Additional responsibilities as assigned to support the evolving needs of the department. Qualifications
Minimum of a B.A./B.S. degree in biology, biochemistry, or related scientific field with 3 years of relevant experience in analytical development, validation, and/or quality control, or M.S. degree. Experience and Skills
Required At least 1 year experience working in a GMP environment Experience with separation techniques such as HPLC, UPLC, CE, iCIEF, or other advanced technology. Understanding and adherence to ALCOA principles for documentation. Strong organizational skills and ability to manage work to meet project timelines. Capability to work independently with minimal supervision. Ability to identify and resolve common technical issues. Effectively engage, communicate, and collaborate with others. Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning. A willingness to occasionally work irregular hours, including evenings and weekends, as needed. Preferred Technical expertise with compendial testing such as visible and sub-visible particles, pH, osmolality, color, and/or clarity. Knowledge of USP, EP, ICH, and FDA regulations. Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms. Experience with electronic notebooks. Experience with Mass Spectrometry analysis. Knowledge of deviation management and change control processes. Equal Employment Opportunity
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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.
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Validate and implement analytical methods to support release and stability testing of clinical materials. Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP). Act as subject matter expert (SME) across various franchises and analytical platforms. Support biologics registrations, product launches, and troubleshooting activities. Support compliance audits, inspection activities, and investigation/CAPAs. Author and review technical documents. Complete assigned work within established project timelines. Ensure adherence to GMP standards and facilitate ongoing enhancement of laboratory processes. Manage laboratory equipment, laboratory supplies and critical reagent inventories. Additional responsibilities as assigned to support the evolving needs of the department. Qualifications
Minimum of a B.A./B.S. degree in biology, biochemistry, or related scientific field with 3 years of relevant experience in analytical development, validation, and/or quality control, or M.S. degree. Experience and Skills
Required At least 1 year experience working in a GMP environment Experience with separation techniques such as HPLC, UPLC, CE, iCIEF, or other advanced technology. Understanding and adherence to ALCOA principles for documentation. Strong organizational skills and ability to manage work to meet project timelines. Capability to work independently with minimal supervision. Ability to identify and resolve common technical issues. Effectively engage, communicate, and collaborate with others. Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning. A willingness to occasionally work irregular hours, including evenings and weekends, as needed. Preferred Technical expertise with compendial testing such as visible and sub-visible particles, pH, osmolality, color, and/or clarity. Knowledge of USP, EP, ICH, and FDA regulations. Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms. Experience with electronic notebooks. Experience with Mass Spectrometry analysis. Knowledge of deviation management and change control processes. Equal Employment Opportunity
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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.
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