Associate Principal Scientist, Downstream Biologics Process R&D

Job Description

The Biologics Process Research & Development organization within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics, and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and the development and implementation of new manufacturing technologies. We work with our partners in the company's Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and experienced individual to join our Downstream Process Development and Engineering group as an Associate Principal Scientist.  In this role, you will work with a highly collaborative team of Scientists and Engineers to design and develop downstream purification processes in support of early and late-stage biological products.   The scope and activities include designing and optimization of downstream unit operations such as cell harvest, filtration, chromatography, viral clearance, precipitation, crystallization, and continuous processing for batch and intensified/continuous bioprocesses.  The role will also include strategic Applicants should have effective organizational and multi-tasking skills and strong communication skills both verbal and presentation of data is required. A track record of leveraging data science and digital tools for delivering impactful solutions to complex problems are distinguishing.  Evidence of strong cross-functional collaboration, experience successfully mentoring junior scientists, leading projects, and an external presence through scientific excellence are expected.

JOB RESPONSIBILITIES:

The successful candidate will contribute to CMC development of our company's pipeline, playing an active role in development of downstream processes and transfer to clinical and commercial manufacturing sites. She/He will also develop strategies for process and pipeline-facing innovation.  

Responsibilities include:

• Leading biologic downstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable processes. Independently designing and conducting experiments using relevant operational parameters and analytical inputs.

• Providing technical supervision for process development and characterization

• Collaborate with upstream process development, Biologics Analytical R&D, and other cross-functional teams in both Research and Manufacturing to advance biologics pipeline.

• Advancing downstream platform process technical strategy, and championing creative process improvement initiatives

• Assessing new technologies, sciences, and industry strategies and relevance to our company

• Collaborating with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies

• Keeping up to date with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies

• Mentoring junior scientists

EDUCATION REQUIREMENTS: 

• Ph.D. with 3+ years of industry experience or Master with 6+ years industry experience or BS with 8+ years in industry experience in Chemical Engineering, Biochemical engineering, or a related field

REQUIRED SKILLS:

• Proven record of accomplishments in downstream process and technology development with a scientific publication and presentation track record.

• Scientific understanding of the engineering principles for recombinant protein purification unit operations. Proven ability to design and execute protein purification experiments independently.

• Ability to direct the planning, execution, analysis, and documentation of all stages of downstream process development.

• Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors

• Knowledge of biologics CMC development cycle

• Demonstrated ability for taking initiative, creativity, and innovation in problem solving

PREFERRED SKILLS:

• Experience with high throughput experimentation using automation platforms such as TECAN

• Experience using and/or programming process control systems such as DeltaV and PCS 7

• Experience with integrated and continuous processing and equipment including multi-column chromatography systems (BioSMB, PCC, or similar)

• Background or experience in data science approaches related to downstream processes and predictive modeling (multivariate data analysis, machine learning/artificial intelligence, leveraging PAT)

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 separationpackage, 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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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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. 

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