Job Information
Merck Senior Scientist, Sterile Drug Product Commercialization in West Point, Pennsylvania
Job Description
We are seeking a Growth and Improvement minded Sterile Drug Product Commercialization Senior Scientist that can help drive our Strategic Operating Priorities.
Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Strategic Summary
The Sterile Drug Product Commercialization group within our Manufacturing Division is based out of West Point, PA and is the division’s leader in Sterile Product and Process Development, process scale up, and technology transfer. The department is a key enabler of new market authorizations and product launches, while providing technical support and product life cycle management for all injectables in our sterile drug products portfolio. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of novel Vaccines, Biologics, and Pharmaceutical products and combination products. The Sterile Drug Product Commercialization Senior Scientist (manufacturing science and technology) organization is a senior drug product scientist responsible to establish and execute commercial process development studies for targeted pipeline and inline programs and develops robust and scalable manufacturing processes while minimizing time to launch. Implements process improvements to reduce cost structure and enhance robustness process.
Job Duties include but are not limited to the following:
Executes drug product (DP) development and commercialization studies, new product introduction and process validation at commercial sites
Designs and conducts experiments to establish robust commercial sterile drug product processes and integrated control strategies | Leads or attends pharmaceutical product working groups
Manages DP activities for in line and pipeline programs, including completion of regulatory filings and product life-cycle management
Authors technical protocols for studies, ensures appropriate design of experiments and sample size selection | Ensures acceptance criteria for study outcomes are pre-defined (e.g. performance parameter range, systematic result range etc.)
Sample submission and tracking. Employs statistical tools and methods to evaluate results
Authors technical reports that can be used as source documentation for regulatory filing | Ensures technical information is clearly understood and integrated into result finding
Conducts second-person review (SPR) for high-quality CMC sections for regulatory submissions
Ensures commercialization programs meet requirements related to science, quality, reliability, schedule and cost
Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline. Uses advanced knowledge gained on scientific/technical issues to guide others to address non-routine and/or difficult issues
Serves on cross functional teams to promote strategic initiatives
Drives continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination products presentations
Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion
Education and Experience:
B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six years relevantexperience; or
Master degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with four years relevant experience; or
Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with relevant academic experience
Skills:
Work objectively and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect
Analytical problem-solving skills
Preferred Experience and skills:
Knowledge in Good Documentation Practices (GDPs)
Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and ICH guidelines
Expertise with utilization of QbD principles for process development
Expertise in authoring and reviewing CMC regulatory documentation
Expertise in process optimization, scale-up and technology transfer of sterile products to pilot/commercial
Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Residents of Colorado
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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
Job Posting End Date:
06/27/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 06/27/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R298513