2022 Associate Scientist, Manufacturing Science & Technology

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Our company, 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 our company has codified its 130-year legacy. Our company’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our Manufacturing Division, 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 is committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

This posting is for a student to start their professional career within Manufacturing Science & Technology (MS&T) upon graduation. MS&T represents a collection of technical operations and commercialization groups, further described below, across the large and small molecule organizations within the Manufacturing Division. A “Safety First, Quality Always” mindset and drive for continuous improvement and innovation enables the Company to be a trusted and competitive supplier of pharmaceuticals, vaccines, biologics, and animal health products to the world’s patients and customers.

MS&T GENERAL PROFILE

Sterile Liquid Commercialization (SLC), Vaccine Process Development and Commercialization (VPDC), and Biologics Process Development and Commercialization (BPDC) are part of Manufacturing Systems Design and Commercialization (MSDC). MSDC is responsible for building and ensuring optimal onboarding of manufacturing facilities, delivering rapid scientific and engineering support for new product development and commercialization, and providing thorough technical investigations for existing products.

SLC is based in West Point, PA and is responsible for product development, process scale-up, technology transfer, registration support, and launch support for formulation and filling of sterile pharmaceuticals, vaccines, and biologics drug product programs from Phase II through initial years of product launch.

VPDC is based in West Point, PA and focuses on late-stage process development, technology transfer, and in-line support of vaccine drug substances and licensure of novel vaccine candidates across cell culture/fermentation (upstream) and purification (downstream). BPDC is based in West Point, PA and Kenilworth, NJ and contributes to commercialization activities and commercial manufacturing support for late-stage biologic drug substances (therapeutic proteins).

Pharmaceutical Commercialization Technology (PCT) is part of Global Pharmaceutical Commercialization (GPC). GPC uses focused innovation to commercialize world class pharmaceutical manufacturing processes, products, and supply chains that deliver value to patients. PCT is based in West Point, PA and Rahway, NJ and is responsible for pharmaceutical process and technology development for oral solid dosage drug products from Phase IIb through regulatory filings, process validation, and the first few years of commercial launch.

Global Vaccine Technical Operations (GVTO) is based in West Point, PA. GVTO provides technical support to the vaccine manufacturing areas, supporting manufacturing investigations, validation activities, and process improvement projects to ensure the highest quality of raw materials, intermediates, and finished vaccine products.

Global Technical Operations (GTO) within the Global Biologics and Sterile Operating Unit (GBSO) is based in West Point, PA. GTO-GBSO supports technical transfers and commercial manufacturing operations for biologics and vaccines intermediates and sterile drug products manufactured by external partners as well as internal sites.

A person in an entry-level MS&T role may have the opportunity to:

• Participate in diverse and collaborative project teams and working groups that support the development and commercial manufacture of company products.

• Plan, conduct, and interpret process development studies, including scale-up/scale-down, investigations, design space development, clinical and formal stability batch manufacture, and process validation, and contribute to regulatory filing documentation.

• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause. Identify and resolve technical and operational problems using lean/six sigma tools and an integrated production system (Hoshin, Kata, value stream mapping).

• Document experimental protocols, lab activities, results, and conclusions in lab notebooks and scientific reports and present knowledge at appropriate forums to support product development.

• Utilize Quality Risk Management (QRM) / Quality by Design (QbD) methodologies and tools around statistical design of experiments (DOE) and analysis of experimentation (ANOVA, PCA, Design Expert, Minitab, JMP).

• Author and update technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control, and validation.

• Ensure proper documentation and compliance with current good manufacturing practices (cGMPs) and federal, state, and local regulations.

• Support facility start-up activities and provide on-the-floor support for manufacturing both within the internal network and at contract manufacturing organizations (CMO).

• Travel to domestic and global research and manufacturing sites as required.

QUALIFICATIONS:

Required Education and Experience:

• Candidates must have Bachelor's Degree or higher in engineering, science, or related discipline from an accredited college/university. No prior experience is required.

• Candidates must have current 2021 summer intern or co-op, graduating in Dec-2021 or Spring-2022

• Candidates must have strong problem-solving, collaboration, and written and oral communication skills

• Candidates must have a desire to discover, develop, and provide innovative products and services that save and improve lives around the world

Preferred Experience and Skills:

• Candidates should have proven ability to work independently and collaborate effectively as part of a team.

• Candidates should have strong organizational, interpersonal, writing, and time management skills.

• Candidates should have experience with chemical or biochemical engineering-related technology development.

• Candidates should have experience with process development in a laboratory, pilot-scale, or manufacturing environment.

• Candidates should have experience with statistical data analysis tools such as design of experiment, multivariate data analysis, and/or process modeling.

• Candidates should have demonstrated capability to develop and execute an experimental program to address issues with process robustness, productivity, and/or cost, integrating efforts with subject matter experts and partners in other functions.

• Candidates should have Vaccines Process Development & Commercialization
  (VPDC) role only: Experience with upstream lab or pilot-scale microbial or cell culture process (fermenters, bioreactors, static cell culture), large molecule purification (chromatography, filtration, centrifugation), and/or large molecule assay development and execution (HPLC, UPLC, MS).

• Candidates should have Biologics Process Development & Commercialization (BPDC) role only: Scientific understanding of cell biology and engineering principles for recombinant protein production with mammalian cell culture. Experience with cell culture aseptic techniques, assays, and general laboratory practices.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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FTP2022 SD2021

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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.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R124091