Principal Scientist, Bio Process - Rahway New Jersey

Company: Hispanic Alliance for Career Enhancement
Location: Rahway, New Jersey
Posted On: 05/02/2025

Job Description

The Biologics Process Research & Development organization within our Company Research Labs 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 development and implementation of new manufacturing technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and experienced individual to join our Upstream Development Department as a Principal Scientist. In this role, the successful candidate will work closely with scientists in the Upstream Development Department to develop and refine technical strategy related to next generation processing for assets in early- and late-stage clinical development. Applicants must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities. 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 scientist, leading projects, and strong 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 cell culture 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 upstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable cell culture processes.
• Providing technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs an BLAs for our company pipeline.
• Advancing upstream platform process technical strategy and championing creative process improvement initiatives.
• Initiating new collaborations to assess new technologies and industry strategies with relevance to our Company.
• Collaborating with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies with broad impact to projects or platform.
• Keeping up to date with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies.
• Mentoring and educating junior scientists.
  
  Minimum education required:
  
  • Ph.D. with 6+ years of industry experience or Master with 8+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field.
    
    Required experience and skills:
    
    • Proven record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
    • Experience in CHO fed-batch cell culture and a working understanding of downstream & analytics.
    • Understanding and hands-on experience on cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities.
    • Working knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics and computational fluid dynamics.
    • Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture 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.
    • Demonstrated ability to develop staff to maximize utilization of talent and actively guides career development; builds strong and collaborative teams.
      
      Preferred experience and skills:
      
      • Experience with state-of-the-art cell culture processes including intensified inoculum and perfusion process development.
      • Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization.
      • Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.
      • Expertise in media development, media/solution chemistry.
      • Background in data science approaches related to cell culture and predictive modeling e.g., metabolic flux analysis (MFA), omics, machine learning; experience integrating PAT efforts) and computational fluid dynamics (CFD).
      • Experience leading cross functional, program development teams.
        
        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.
        
        As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
        
        EEOC Know Your Rights
        
        EEOC GINA Supplement
        
        We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
        
        Learn more about your rights, including under California, Colorado and other US State Acts
        
        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.
        
        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
        
        Search Firm Representatives Please Read Carefully
        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:
        
        Valid Driving License:
        
        Hazardous Material(s):
        
        Job Posting End Date:
        05/2/2025
        *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:R328501
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