Associate Principal Scientist, Upstream Development

Job Description

Job Description:

The Biologics Process Research & Development organization within our company's Research Laboratories 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's Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and energetic individual to join our Biologics Process Development Department as an Associate Principal Scientist.  Applicant 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.

In this role, the 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. She/He will also participate in developing and refining strategies related to next-generation processes through technology development initiatives for assets in early and late-stage clinical development. 

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 up to date with the external patent and literature environment; actively present and publish externally and pursue patenting strategies.

MINIMUM EDUCATION REQUIREMENTS: 

• Ph.D. with 3+ years' experience or master's with 7+ 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.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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:

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

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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. 

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