Associate Principal Scientist - Biologics and Vaccine Analytics Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Biologics ad Vaccine analytics (BVA), part of Merck Manufacturing Division (MMD), is responsible for analytical activities supporting commercialization of vaccines and biologics from Phase III through launch and transfer to supply as well as in-line analytical support to enable world-wide robust vaccine and biologics availability. BVA supports process development, optimization, late-stage and life-cycle management activities, including interfacing with a network of facilities for product manufacturing and testing, analytical optimization, assay validation, analytical technical transfer, BLA filing documentation, troubleshooting and interfacing with national regulatory authorities.
Responsibilities of the Associate Principal Scientist will include and are not limited to the following:
- Responsible for interfacing across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of vaccine analytics.
- Will coordinate with analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and transfers between Merck, external partners and CMO/CROs.
- Experience in analytical development and quality control (QC), with a working knowledge of current Good Manufacturing Practices (cGMP).
- At any given time, could be responsible for contributing to and coordinating analytical activities across multiple projects.
- Will also lead cross functional teams and ensure alignment with analytical strategies and Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel vaccines and processes.
- Develop and optimize cell-based, microbiological, immunochemistry-based analytical methods.
- Prepare and execute analytical method transfers and assay method validations - write and coordinate review of protocols and reports.
- Provide on-going support to internal and external partners to resolve analytical issues and trouble-shooting.
- Assist in the development and execution of critical reagent qualification protocols and stability studies.
- Assist with the technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods.
- Contribute as author to regulatory submissions.
- Oversee individual contributors as appropriate
Education Minimum Requirement:
Required: B.S. in Biochemistry/Biological Sciences or equivalent
Preferred: M.S. in Biochemistry/Biological Sciences or equivalent
Required Experience and Skills:
Minimum of (5) years relevant Late-Stage Industry experience
Demonstrated strong technical background in Assay Development, Validation, Technical Transfer, and Trouble-shooting
Experience preparing and executing Assay Validation and Transfers Protocols and Reports
Preferred Experience and Skills:
Demonstrated Organizational and Project Management skills
Demonstrated oral and written communication skills.
Ability to work independently with minimal supervision.
Ability to rapidly establish and lead teams and successfully collaborate across functions and departments.
Effectively identify and communicate risks
Strong interpersonal skills and proven ability to lead cross-functional teams
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Job: Biologics, Vaccines, Analytical Formulat
Job Title:Assoc Prin. Scientist, Bio & Vacc Formul
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: General cell biology, microbiology labroatory reagents
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Analytics, Biochemistry, Microbiology, Scientific, Data Analyst, Engineering, Management, Science, Data