Job Description
As part of our Company 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, 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.
In this role, you will be responsible for:
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.
Executing the hands-on execution of lab-scale experiments and authoring associated technical reports and documents.
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.
Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.
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:
B.S. or M.S. in Chemical Engineering, Chemistry, Biology or comparable discipline.
Required Knowledge and Skills:
Upstream process development and manufacturing sciences knowledge
Ability to work independently and as part of a team to execute against key commitments.
Candidates should have excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
Expertise in lab-scale experimental execution, statistical data analysis, presentation of results/conclusions, and the application of principles/theory into process design and practice.
Preferred Experience and Skills:
Experience with upstream lab or pilot-scale fermentation or cell culture processes.
High throughput fermentation or cell culture experience.
Experience authoring technical documentation to support regulatory submissions.
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.
Current Good Manufacturing Practice (cGMP) experience.
Analytical method execution or development.
Experience with instrument maintenance and troubleshooting.
Experience with the following software: JMP, Spotfire, PI Process Book, or similar; experience with Design of Experiments (DOE).
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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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”.
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.
