Senior Scientist, Biologics Process Development & Commercialization


MERCK
West Point, PA 19486
United States

Category  Jobs / Careers > Science

Description
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck?s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that?s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Biologics Process Development and Commercialization (BPDC), a manufacturing sciences organization within the Merck Manufacturing Division (MMD), is responsible for the commercialization of biological processes (novel therapeutic proteins) from Phase III through launch and transfer to the commercial supply network. Activities include process scale-up/scale-down, characterization and optimization, interfacing with a network of facilities for product manufacturing and subsequent validation and filing documentation, tech transfer to the supply network, and commercial product support, including investigations, post-launch process improvement, and development of second generation processes post-approval.
Under the general scientific and administrative direction of the Director of BPDC Upstream Process Development and Commercialization, and working in conjunction with internal and external partners, this individual will support late stage bulk process development, characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to therapeutic proteins. The individual will demonstrate scientific, experimental and tech transfer skills focused on cell culture processes.
Responsibilities:
+ Provide technical support and leadership in manufacturing sciences for drug substance development, characterization and commercialization teams, including the design, execution, and interpretation of lab-scale, pilot-scale and manufacturing-scale elements of a technical program to ensure processes are suitable for PPQ, licensure, and commercial manufacturing
+ Support definition and development of process control strategy
+ Support continuous improvement of post-launch manufacturing process
+ Identify and evaluate new/innovative technologies and work to implement new platforms with cross-functional early and late stage development teams
+ Manage technical programs, including establishing and delivering on project timelines and milestones
+ Partnering with commercial manufacturing teams to provide upstream subject matter expertise to support ongoing manufacturing activities
+ Provide global support for commercial products (e.g. technical support, trouble shooting, deviation resolution, change control)
+ Author, review and edit technical documents to support regulatory filings including technical reports, risk assessments, and CTD sections
Education:
+ B.S. in Chemical Engineering or Biochemical Engineering or related field with 7 years of relevant experience; or Master's degree with 4 years of relevant experience; or Ph.D. with 0 years of relevant experience in the above mentioned field
Required:
+ Upstream process development, characterization and manufacturing sciences experience, including scaling (up and down) along with tech transfer, of mammalian cell culture and/or microbial fermentation processes
+ Commercialization experience in biologics, vaccines or other therapeutic proteins
+ Deep technical knowledge and in-depth experience with upstream process development
+ Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development
+ Outstanding communication and people skills
+ Ability to design and execute studies and experiments in the context of long-term commercialization plans
+ Experience with Quality by Design (QbD), Design of Experiments (DOE), and Lean Six Sigma principles
+ Experience in using software and statistical tools (JMP, Spotfire, SIMCA) for data mining, data analysis, modeling and statistical process control (SPC)
+ Experience with project strategic planning
Preferred:
+ Upstream process development, characterization and manufacturing sciences expertise across multiple programs and platforms
+ Expertise in harvest and primary recovery unit operations (centrifugation, depth filtration) is a plus
+ Knowledgeable in Drug Substance, end to end process development. Strong cross functional background, enabling teams to reach peak performance
+ Ability to provide scientific mentorship and guidance to technical coworkers and colleagues within and outside of Merck
+ Experience supporting/writing regulatory filings (IND, BLA) and inspections with multiple agencies (FDA, EMA, JNDA)
+ cGMP experience
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we?re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we?re inventing for life.
If you need an accommodation for the application process please email us at staffingaadar@merck.com.
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Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.
Job _Process Engineering_
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.
Title: _Senior Scientist, Biologics Process Development & Commercialization_
Primary Location: NA-US-PA-West Point
Requisition ID: _PRO016328_
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