Biologics Process Research and Development (R&D) Downstream Principal Scientist. 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. Biologics Process Resea... more details
Job Description
Position Description:
Biologics Process Research and Development (R&D) Downstream Principal Scientist
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.
Biologics Process Research & Development (BPR&D) within our Company's 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 Company's 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 Biologics Process Research & Development (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
Position Qualifications:
Education Minimum Requirement:
Required Experience and Skills:
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 Chemistry, Manufacturing and Control (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 and 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
Please note that this lab-based role is not eligible for our hybrid work model, but we are committed to promoting work-life balance and offer other flexible arrangements where feasible.
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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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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, generally Tuesday, Wednesday and either Monday or 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”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:
$149,400.00 - $235,100.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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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:
Domestic/International
VISA Sponsorship:
Yes
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
