Scientist, Biologics Analytical R&D
Scientist, Biologics Analytical R&D
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$ 85600 - 134800
1 Vacancy
Job Description
Job Description
Scientist 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 companys extensive range of products from candidate selection to market authorization. At our company we proudly continue to build upon a legacy of groundbreaking innovation while steadfastly upholding the highest standards of ethics and integrity. With a diverse workforce representing a multitude of languages and cultures we stand unified in our collective mission to deliver revolutionary medicines and products with integrity and transparency.
We are actively seeking an enthusiastic individual to join our Rahway NJ team as a Scientist 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 successful candidate must be able to work in a fast-paced multidisciplinary environment and will play a pivotal role supporting Biologics to advance commercialization efforts.
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
At least 1 year experience working in a GMP environment
Experience with separation techniques such as HPLC UPLC CE iCIEF or other advanced technology.
Proficiency with data analytics.
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.
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.
Knowledge of deviation management and change control processes.
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.
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 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:
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 anothers thinking and approach problems collectively.
Learn more about your rights including under California Colorado and other US State Acts
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 Monday - 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 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.
The salary range for this role is
$85600.00 - $134800.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (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 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Adaptability Adaptability Analytical Development Analytical Method Development Applied Engineering Biochemistry Biopharmaceutical Industry Cell-Based Assays Change Control Processes Collaborative Communications Data Analytics Fast-Paced Environments FDA Regulations GMP Compliance Good Manufacturing Practices (GMP) Immunoassays Immunochemistry Interpersonal Relationships Laboratory Information Management System (LIMS) Laboratory Maintenance Laboratory Techniques Mammalian Cell Culture Management Process Multidisciplinary Collaboration Real Time Polymerase Chain Reaction (qPCR) 4 morePreferred Skills:
Job Posting End Date:
06/14/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Employment Type
Full-Time
