Scientist, Engineering - Biologics Process Development and Commercialization

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

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 to 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.

Position Description:

As part of the our Company Manufacturing Division, the Biologics Process Development and Commercialization (BPDC) department provides manufacturing sciences expertise, through technical process leadership and laboratory capabilities, in the commercialization and post-launch support of our Company biologics pipeline. Working closely with colleagues across the biologics network, including our Research & Development Division, Operations, Analytical, and Global Technical Operations (GTO), our department supports upstream cell culture, downstream purification, analytical testing and characterization, and technology transfer of biological processes from Phase III through commercial launch and transfer to the commercial supply network.

Under the general scientific and administrative direction of the Kenilworth lead of BPDC Process Analytics, and working in conjunction with internal and external partners, this individual will support late stage pipeline and commercial biologics, providing deep scientific support for investigations, pre and post-launch process enhancements, technology transfers, and various other commercialization activities, including scale-up/scale-down, process characterization and validation, and authoring of regulatory submissions.

Technical Scope:

• Primary focus will be on in-process analytics, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, purification, and site readiness.

• Represents functional area on cross-functional and cross-divisional teams

• Provides technical leadership for the transfer and/or management of in-process analytical methods to internal and external partners.

• Authors required regulatory and technical documentation according to standard our Company practices.

• Shows flexibility and agility in responding to changing needs across BPDC and our Company.

Position Qualifications:

Education Minimum Requirement:

• BS, MS in Analytical Sciences, Biological Sciences, Chemical Engineering, Biological Engineering, or related field with 2 years (for BS), 1 year (for MS).

Required Experience and Skills:

• Technical knowledge in the characterization of biological molecules.

• Experience with HPLC and/or UPLC method development and execution.

• Experience working in teams in various stages of development and/or commercialization.

Preferred Experience and Skills:

• Knowledgeable in biologics drug substance end-to-end process developments

• Experience with transfer of analytical methods

• Strong cross-functional background, enabling teams to reach peak performance

• Ability to thrive in an ambiguous environment and collaborate across functions

• Strong communication skills with ability to foster a collaborative work environment focused on improving efficiency across BPDC

Our Manufacturing & Supply Division is dedicated to be 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.

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.

Residents of Colorado

Click here to request this role’s pay range.

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

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

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R141970