Job Description

Job Description

As part of Our Companys Manufacturing Division, within the Manufacturing System Design & Commercialization, 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 team supports 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 process characterization, process validation, and regulatory submission authoring.

Under the general scientific and administrative direction of Principal Scientist in Downstream and working in conjunction with internal and external partners, this individual will support these late stage and commercial biologic program activities within the department. The individual will demonstrate scientific, experimental and tech transfer skills focusing on downstream processing.

Scope includes:

* Participates in and/or leads cross-divisional technical teams focusing on late stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.

* Responsible for laboratory-scale and manufacturing scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally. Provides technical leadership for the design of experiments, data analysis and interpretation, as well as mentoring of junior staff in the execution of internal or management of external laboratory activities.

* Provides technical leadership in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control and/or multivariate analyses), and for further technical investigations and process improvement changes

* Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, analytical, and GMP site readiness.

* Actively interacts with internal and external counterparts. Represent functional area on cross-functional and cross-divisional teams.

* Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to standard company practices.

Education Minimum Requirement:

* BS, MS or PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 10 years (for BS), 8 years (for MS), or 4 years (PhD) relevant experience.

Required Experience and Skills:

* Technical expertise in purification of biological molecules, including laboratory models for chromatography and filtration systems.

* Experience with technology transfer and scale-up of processes to pilot and manufacturing scales for biologics manufacture.

* Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.

Preferred Experience and Skills:

* Experience with downstream purification of biological molecules required, with an in-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired. Demonstrated understanding of the fundamentals and/or modeling 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.

* Prior experience in late stage process development, process characterization including viral clearance studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.

* Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)

* Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes.

* Working understanding of analytical methods to characterize biologics and /or US/EU regulatory requirements and / or working knowledge of cGMPs 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 thats committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are

We are known as Our Company., Inc., Kenilworth, New Jersey, USA in the United States and Canada and Our Company 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.

Residents of Colorado

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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.

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 anothers 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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work, Telecommuting

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R85421