Principal Scientist, Downstream Biologics Process R&D

Job Description

Our Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities, cutting-edge science, and technology, we partner to deliver the next medical breakthrough. We are seeking a collaborative, self-directed learner with a penchant for problem-solving and expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Principal Scientist.

BPR&D within our companys Research Laboratories is on a mission to rapidly deliver diverse biotherapeutics to patients by efficiently developing innovative, robust manufacturing processes and technologies. To achieve this, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing while providing a diverse and inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. Examples include investments for development of continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific community to influence the field.

As a Principal Scientist you will have the opportunity to influence the future direction of our companys Downstream Processing of Biologics. You will work with an immensely creative and collaborative team of scientists and engineers to design purification processes while developing technical strategies related to downstream processing for drug candidates in early- and late-stage development.

Responsibilities include but are not limited to:

As an impactful contributor, shape and realize innovation across the Biologics’ pipeline, strategy, and science

Advance the pipeline by collaborating with cross-functional teams, from Research & Manufacturing, in a fast-paced, multidisciplinary environment

Participate in or lead 1) development of robust and scalable purification processes for biologics in different stages of clinical development, 2) process characterization and regulatory filings for successful commercialization

Advance downstream processes by improving efficiency and cost effectiveness through research and innovation, while assessing technologies and industry best practices

Collaborate with academia, industry, and vendors to drive development and early adoption of novel process technologies

Contribute to strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams towards its execution

Conceptualize, plan, and execute projects with effective organizational, prioritization and problem-solving skills

Stay abreast of scientific and regulatory landscape; actively present (premier conferences), publish (peer-reviewed journals) and patent

Represent BPR&D as a downstream bioprocess expert in internal, cross-functional project teams and external conferences/consortia

Mentor and actively share expertise; guide career development; build strong, collaborative teams

Champion compliance and safety; promote a culture of diversity, inclusion, and equity

MINIMUM EDUCATION REQUIREMENTS:

Ph.D. with 6 years, MS with 8 years, or BS with 10 years of industry experience and background in Chemical/Biochemical engineering, or a related field

REQUIRED EXPERIENCE, SKILLS, AND COMPETENCIES

Strong fundamental knowledge and subject matter expertise in downstream processing of biologics, recent advances, and challenges in the field

Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of purification process development

Track record of accomplishments in downstream bioprocessing with a history of peer-reviewed publications and presentations

Knowledge of biologics CMC development

Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment

Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams

Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve

Demonstrated commitment to coach and mentor staff to maximize talent development and utilization

Excellent interpersonal and communication skills

PREFERRED EXPERIENCE & SKILLS:

Leadership of CMC development teams

Continuous biomanufacturing integrated with process-analytical technologies

High-throughput experimentation, automation, and process control

Knowledge of protein expression, analytics, conjugation chemistry and formulation

Biophysical, mechanistic and facility modeling; statistical analysis, data-science, machine learning, artificial intelligence

#BPRD #PRD

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.

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U.S. Hybrid Work Model

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.

Expected US salary range:

$149,400.00 – $235,100.00

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 (https://www.benefitsatmerck.com/) .

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.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

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Job Posting End Date:

11/8/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R316900