Scientist, Engineering- Cell Culture and Fermentation Sciences

Job Description

As part of our Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market (in-line) commercial manufacturing processes for vaccines and biologics. CCFS supports various commercialization activities including second generation process development including process characterization, technology transfer to internal and/or external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.

Under the general scientific, technical, and administrative direction of a CCFS Group Leader in West Point, we seek a motivated scientist/engineer to support development and licensure of novel vaccine candidates and in-line products. Working in conjunction with internal and external partners, this colleague will sponsor late-stage bulk process development, characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to therapeutic proteins & vaccines. The person will demonstrate scientific, experimental and tech transfer skills focused on fermentation and/or cell culture processes.

Position Tasks:

• Functioning as a key member of the process development team through executing lab-scale process development, in-process assay support, and process scale-up or scale-down of cell culture/fermentation (upstream) process unit operations.
• Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing.
• Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
• Contributing to commercialization activities of late-stage pipeline and /or commercial manufacturing support for vaccines or biologics (therapeutic proteins). Contributions may include support of technology transfer activities, process validation studies, manufacturing investigation and trend evaluations, process enhancements, process development and characterization, and authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.
• Responsible for performing design, planning, and hands-on execution of laboratory experiments and investigations for the purposes of generating new data and knowledge. Authors experimental protocols and documents work in a lab notebook. Documents lab activities, findings, and conclusions in scientific reports, and presents knowledge at appropriate forums. Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations.
• As an individual contributor, will be concerned with clearly identifiable elements or functions within a larger project team. May oversee and coordinate work performed by contractors.
• Contribute to a safe and compliant laboratory work environment.
• This role may require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing.

Education:

• Bachelor's Degree with a minimum of 2 years of relevant experience; or Master's Degree (non-thesis) with a minimum of 1 year of relevant experience in Chemical Engineering, Chemistry, Biology or comparable discipline.

Required Knowledge and Skills:

• Experience with upstream lab or pilot-scale microbial or cell culture process (fermenters, bioreactors, static cell culture)).
• Experience with process development in a laboratory setting in executing lab activities, including: authoring study protocols, planning and performing experiments, documenting experiments in a lab notebook, managing, submitting, and testing samples, performing data analysis, and writing technical reports.
• Experience in lab-scale experimental execution, statistical data analysis, presentation of results/conclusions, and the application of principles/theory into process design and practice.
• Proven ability to work independently and as part of a team and execute against key commitments.
• Strong problem solving and communication skills, and competency in technical writing.
• Strong cross-functional background, enabling teams to reach peak performance.
• Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
• Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.

Preferred Experience and Skills:

• Upstream process development and manufacturing sciences knowledge.
• Scientific comprehension of cell biology and engineering standards for recombinant protein production with mammalian cell culture or microbial fermentation.
• High throughput cell culture/fermentation technique and automation.
• Bioreactor and/or process control systems such as MFCS and DeltaV.
• Bioanalytical and aseptic techniques such as plating, microscopy, and biochemical/cell functional assays.
• Experience with instrument maintenance and troubleshooting.
• Experience with large molecule commercialization (facility start-up, technology transfer).
• Experience within pilot-scale, or manufacturing environment.
• Large molecule drug substance process development, scaling (up and down) and tech transfer.
• Experience authoring technical documentation to support regulatory submissions.
• Current Good Manufacturing Practice (cGMP) experience. Design of Experiments (DOE) and Lean Six Sigma standards.
• Experience with the following software and statistical tools (JMP, PI ProcessBook/PI Vision, Spotfire, SIMCA) for data mining, data analysis, modeling, and statistical process control (SPC).

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US and Puerto Rico Residents Only:

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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".

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.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
biohazards and chemicals

Job Posting End Date:
12/11/2024
*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:R324133