Associate Principal Scientist, Upstream Process Development

Merck; Rahway (NJ); Sur place; USD 150 000 - 190 000; Plein temps

Résumé du poste

Merck in Rahway, New Jersey, is seeking an Associate Principal Scientist to lead upstream process development for biotherapeutics. You will design, develop, and optimize cell culture processes and transfer into clinical and commercial manufacturing, partnering with Discovery, Downstream Process Development, Analytical Sciences, and Manufacturing.

The role requires strong scientific leadership, cross-functional collaboration, and mentoring of junior staff, with emphasis on process improvement,

Qualifications

• Ph.D. with 4+ years' experience or Master's with 8+ years' experience in chemical engineering, Bioengineering, Biological Engineering, or a related field
• Hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins
• Experience with CHO cell biology, metabolism, and large-scale production systems
• Familiarity with statistical methods and data analysis tools
• Experience with bioreactors from bench to pilot scale and scale-up principles

Responsabilités

• Lead upstream process development for high-yield, robust cell culture processes.
• Oversee process development, characterization, and regulatory filing activities for PPQs/BLAs.
• Collaborate with Discovery, Cell Line, Downstream, Analytical Sciences, and Manufacturing for integrated solutions.
• Drive platform improvements to increase efficiency and reduce costs.
• Publish externally and pursue patenting strategies.
• Mentor junior staff and manage cross-functional teams

Connaissances

Mammalian culture

Fed-batch processes

CHO biology

Design of experiments

Bioreactor scaling

Cross-functional teamwork

Communication skills

Project leadership

Bioreactor modeling

Process development

Formation

Ph.D. in Chemical/Bioengineering

M.S. in Engineering

Outils

SIMCA

JMP

Description du poste

Associate Principal Scientist, Upstream Process Development

Location Rahway, New Jersey, United States of America Job Type Full time

This site is for Res idents of the United States, Canada & Puerto Rico.
Residents of other markets, please click here .

Job Description

The Biologics Process Research & Development organization within our Research & Development Division 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 late-stage process development and process characterization to prepare for commercial manufacturing. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and energetic individual to join our team as an Associate Principal Scientist. In this role, a successful candidate will work closely with a highly motivated team of Scientists and Engineers in the Upstream Process Development area and contribute to CMC development of our company's pipeline, playing an active role in the design, development, and optimization of cell culture processes and the transfer of processes to clinical and commercial manufacturing sites. They must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership in Upstream process development, and superior written and oral communications abilities. Evidence of strong cross-functional collaboration, significant external presence with scientific excellence, and interest and abilities for mentoring junior staff are also expected.

Responsibilities include, but are not limited to:

• Participates in and/or leads upstream process development of first-in-human and commercial processes by efficiently developing high yield, robust, and scalable cell culture processes.
• Responsible for process development, process characterization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
• Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies.
• Advancing the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs.
• Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies.
• Keep current with the external literature environment; actively present and publish externally and pursue patenting strategies.
• Ph.D. with 4+ years' experience or Master's with 8+ years' experience in chemical engineering, Bioengineering, Biological Engineering, or a related field

Required Experience and Skills:

• Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins.
• Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems.
• Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.).
• Understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and bioreactor scale-up principles from laboratory to large scale.
• Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
• Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
• Plan, execute, analyze, and communicate complex and critical data in a highly organized manner.
• Excellent verbal, written communication, and interpersonal skills.
• Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
• Productivity and efficiency working in the laboratory.
• Ability to deliver complex objective under aggressive timelines.
• Proficiency in Bioreactor simulation and modeling.

Preferred Experience and Skills:

• Experience with cell culture media development.
• Experience with high throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.
• Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.
• Background in data science approaches related to cell culture and predictive modeling, e.g. metabolic flux (MFA) analysis, omics, machine learning; computational fluid dynamics, and experience integrating PAT efforts.
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
• Knowledge of biologics CMC development cycle and scale-up/down in addition to tech transfer to GMP manufacturing site.

Required Skills: Biological Engineering, Biological Engineering, Biologics, Bioreactors, Biotherapeutics, Cell Biology, Cell Culture Bioreactors, Cell Culture Techniques, Cell Line Development, Chemical Engineering, CMC Development, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Mammalian Cell Culture, Molecular Biology, Patentability, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Process Characterization, Process Development (PD), Recombinant Protein Production, Recombinant Proteins {+ 1 more}

Job Description

The Biologics Process Research & Development organization within our Research & Development Division 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 late-stage process development and process characterization to prepare for commercial manufacturing. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and energetic individual to join our team as an Associate Principal Scientist. In this role, a successful candidate will work closely with a highly motivated team of Scientists and Engineers in the Upstream Process Development area and contribute to CMC development of our company's pipeline, playing an active role in the design, development, and optimization of cell culture processes and the transfer of processes to clinical and commercial manufacturing sites. They must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership in Upstream process development, and superior written and oral communications abilities. Evidence of strong cross-functional collaboration, significant external presence with scientific excellence, and interest and abilities for mentoring junior staff are also expected.

Responsibilities include, but are not limited to:

• Participates in and/or leads upstream process development of first-in-human and commercial processes by efficiently developing high yield, robust, and scalable cell culture processes.
• Responsible for process development, process characterization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
• Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies.
• Advancing the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs.
• Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies.
• Keep current with the external literature environment; actively present and publish externally and pursue patenting strategies.

Minimum Education Requirements:

• Ph.D. with 4+ years' experience or Master's with 8+ years' experience in chemical engineering, Bioengineering, Biological Engineering, or a related field

Required Experience and Skills:

• Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins.
• Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems.
• Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.).
• Understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and bioreactor scale-up principles from laboratory to large scale.
• Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
• Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
• Plan, execute, analyze, and communicate complex and critical data in a highly organized manner.
• Excellent verbal, written communication, and interpersonal skills.
• Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
• Productivity and efficiency working in the laboratory.
• Ability to deliver complex objective under aggressive timelines.
• Proficiency in Bioreactor simulation and modeling.

Preferred Experience and Skills:

• Experience with cell culture media development.
• Experience with high throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.
• Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.
• Background in data science approaches related to cell culture and predictive modeling, e.g. metabolic flux (MFA) analysis, omics, machine learning; computational fluid dynamics, and experience integrating PAT efforts.
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
• Knowledge of biologics CMC development cycle and scale-up/down in addition to tech transfer to GMP manufacturing site.

Required Skills: Biological Engineering, Biological Engineering, Biologics, Bioreactors, Biotherapeutics, Cell Biology, Cell Culture Bioreactors, Cell Culture Techniques, Cell Line Development, Chemical Engineering, CMC Development, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Mammalian Cell Culture, Molecular Biology, Patentability, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Process Characterization, Process Development (PD), Recombinant Protein Production, Recombinant Proteins {+ 1 more}

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

The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $