Principal Scientist, Bio Process

Job title: Principal Scientist, Bio Process in Rahway, NJ at reputed company Company: reputed company Job description: Job DescriptionThe Biologics Process Research & Development organization reputed company 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 reputed company manufacturing processes for diverse biotherapeutics and reputed company 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 reputed company 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 reputed company and refine technical strategy reputed company to reputed company 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 reputed company problems are distinguishing. Evidence of strong cross-functional collaboration, experience successfully mentoring junior scientist, leading projects, and strong external reputed company 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 reputed company strategies for process and pipeline-facing innovation. Responsibilities include:Leading biologic upstream process development for first-in-human and commercial processes by reputed company 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 reputed company 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 reputed company & 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 reputed company 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 reputed company 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 reputed company 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.reputed company Employees applyreputed company Contingent Workers applyUS 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 if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to reputed company employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company 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: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 reputed company people with diverse reputed company, 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.U.S. Hybrid Work ModelEffective 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 reputed company.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 reputed company 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 - $235,100.00Available 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 .San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment reputed company qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company 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 reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation:reputed company Sponsorship:Travel Requirements:Flexible Work Arrangements: Not ApplicableShift:Valid Driving License:Hazardous Material(s):Required Skills:Preferred Skills:Job Posting End Date: 06/27/2025*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 reputed company than the day BEFORE the job posting end date. Expected salary: Location: Rahway, NJ Apply for the job now! Apply for this job