Scientist, Downstream, Biologics Process Development and Commercialization

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, 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 Manufacturing Division, within the Manufacturing System Design & Commercialization organization, the Biologics Process Development & Commercialization department provides the technical process leadership and laboratory capabilities in support of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). For pipeline programs, the department supports various commercialization activities, including technology transfer to internal and external manufacturing sites, process characterization, 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 process characterization, process validation, and regulatory submission authoring.

As part of the Downstream Process Sciences group, this individual will be part of a team of scientists and engineers supporting late stage and commercial biologics programs with a focus on downstream processes and laboratory capabilities. The individual will demonstrate scientific and experimental skills focusing on downstream processing.

Education Minimum Requirement:

• BS or MS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 2 years (for BS) or 0 years (for MS) relevant experience.

Required Experience and Skills:

• Theoretical understanding or practical experience in protein biochemistry and/or separation sciences as it relates to purification of biological molecules.

• Excellent oral and written communication skills. Good working knowledge of general office software (e.g., Microsoft Word, Powerpoint, etc)

Preferred Experience and Skills:

• Experience with downstream purification of biological molecules desired. Demonstrated understanding of the separation principles of unit operations is a plus.

• Technical operations experience in the manufacture of biological molecules at the pilot- and/or commercial-scale is a plus.

• Practical experience in biologics process development, manufacturing batch record reviews and/or operations, authoring regulatory BLA sections are all advantages for this role.

• Working knowledge of statistics (e.g., statistical process control (SPC), multivariate analysis (MVA), o Design of Experiments (DoE)) including use of software such as JMP or Design Expert is a plus

• Working understanding of analytical methods to characterize biologics is a plus

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed 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 …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

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:

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R117565