Senior Scientist, Engineering

Job Description

Our Company Manufacturing Division is a team of dedicated, energetic individuals who are committed to be 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.

As part of the Our Company Manufacturing Division, within Manufacturing Systems Design and Commercialization (MSDC), the Biologics Process Development and Commercialization (BPDC) department provides the technical process management and laboratory capabilities in sponsor of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). For pipeline programs, BPDC promotes various commercialization activities, including technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, the scope includes site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process (i.e., post approval) development and characterization, process validation, and regulatory submission authoring.

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 colleague will sponsor 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 person will demonstrate scientific, experimental and tech transfer skills focused on cell culture processes.

Position Tasks:

• Contributes to commercialization activities of late stage pipeline and /or commercial manufacturing sponsor for biologics (therapeutic proteins) | Late stage pipeline commercialization, activities include technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions | Commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring

• Technical direction on design, planning, and executing laboratory experiments and investigations for the purposes of generating new data and knowledge | Authors experimental protocols and documents work in a lab notebook. Documents lab activities, findings, and conclusions in scientific reports, and presents knowledge at appropriate forums | Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations

• Managing large multifaceted projects as the principal of a cross-functional team | principal contributor, may be concerned with clearly identifiable elements or functions within a larger project team | Oversee and coordinate work performed by contractors

• Systematically and scientifically conducting cell cultures experiments for process development activities and comprehension/troubleshooting manufacturing deviations and raw material assessment

• Train junior staff for operations in laboratory-scale and pilot-scale bioreactors

• Contribute to a safe and compliant laboratory work environment

• Working outside of core business hours to promote lab studies and/or on-site activities related to tech transfer and manufacturing

• GMP tasks include authoring, reviewing and approving technical and regulatory documents

Education:

• B.S. in Chemical Engineering or Biochemical Engineering or related field with a minimum six years of relevant knowledge; or Master's in Chemical Engineering or Biochemical Engineering or related field with a minimum four years of relevant Knowledge; or Ph.D in Chemical Engineering or Biochemical Engineering or related field with a no minimum relevant knowledge

Knowledge and Skills

• Upstream process development and manufacturing sciences knowledge

• Scientific comprehension of cell biology and engineering standards for recombinant protein production with mammalian cell culture

• Ability to execute studies and experiments in the context of long-term commercialization plans

• Cell culture aseptic technique, assays and general laboratory practices

• Proven ability to design and execute cell culture experiment objectively from protein expression to different cell culture scales including shaker flasks and bioreactor

• Subject Matter Expert on processes such as fed batch and perfusion.

• partner with downstream, process analytics, and other functional teams in both R&D and manufacturing to advance biologics inline/pipeline.

• Knowledge with statistical data analysis

• tools such as design of experiment and multivariate data analysis

• Strong passion and investment to integrate science to biologic process development

• Ability to foster a combined work environment

• Outstanding communication and people skills

Preferred Skills

• High throughput cell culture technique and automation

• Perfusion cell culture and cell retention devices such as ATF, TFF, acoustic wave etc.

• Bioreactor and/or process control systems such as MFCS and DeltaV

• Bioanalytical techniques such as flow cytometry, microscopy, biochemical assays and cell functional assays

• Design of Experiments (DOE), and Lean Six Sigma standards

• Software and statistical tools (JMP, Spotfire, SIMCA) for data mining, data analysis, modeling and statistical process control (SPC)

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.

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.

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.

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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.

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R129389