Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

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.

As part of our Company’s Manufacturing Division, within Global Vaccines and Biologics Commercialization (GVBC), the Biologics Process Development and Commercialization (BPDC) department provides the Drug Substance technical process leadership and laboratory capabilities in support of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). For pipeline programs, BPDC leads 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 deep manufacturing sciences and technology support, process enhancements, next generation process (i.e., post approval) development and implementation.

Under the general scientific and administrative direction of the area lead in Upstream and working in conjunction with internal and external partners, this individual will support these late stage commercialization and commercial biologics program activities within BPDC. The individual will demonstrate scientific and experimental skills focusing on upstream processing.

Responsibilities

• Conduct and initiate laboratory experiments and investigations for the purposes of generating new data and knowledge
• Authors experimental protocols | Documents lab activities, findings and conclusions in lab notebook and 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
• Supports the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA))
• Authors required regulatory and technical documentation

Education Requirement

• Bachelor Degree in Engineering, Science or related field with a minimum of two years of relevant experience; or Master’s Degree (non-thesis) with a minimum of one year of relevant experience

Experience and Skills

Required

• Aseptic operations and direct experience working with Mammalian cell lines
• Instrumentation (BSCs, cell and metabolite measurement, small scale bioreactors set-up and operations) used for mammalian cell culture
• Understanding of scale down and scale up within biopharma industry
• GLP and Data Integrity
• Theoretical understanding of cell culture metabolism and operations
• Data analysis including large data
• Direct experience with ELN
• Principled verbal and written communication skills

Preferred

• Pilot scale bioreactor operations
• Downstream and Analytical operations
• Biopharma manufacturing operations
• Effective working knowledge of general office software (e.g., Microsoft Word, PowerPoint, etc.)

Schedule Requirements

• May require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing

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.

US and Puerto Rico Residents Only:

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.

Pay Transparency Nondiscrimination

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

Yes

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

2

Requisition ID:R136687