Job Description

Position Description:

Associate Scientist, Cell Culture and Fermentation Sciences

As part of Our Company's 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 commercial manufacturing processes for vaccines and biologics.

CCFS supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.

Under the general scientific and administrative direction of the Director of Bioprocess Drug Substance Commercialization (BDSC) Cell Culture Fermentation Sciences Kenilworth, and 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 cell culture processes.

Position Tasks:

• Contributes to commercialization activities of late-stage pipeline and /or commercial manufacturing support for 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 technical report

• Responsible for performing design, planning, and executing 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 Minimum Requirement:

• Bachelor's Degree or Master's Degree in Engineering, Science or related field.

Required Experience and Skills:

• Candidates should have experience 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.

• Candidates should have strong cross-functional background, enabling teams to reach peak performance.

• Candidates should have competency in technical writing.

• 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.

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

• High throughput cell culture technique and automation

• Perfusion cell culture and cell retention devices such as ATF, TFF, acoustic wave etc.

• Bioreactor and/or process control systems such as MFCS and DeltaV

• Bioanalytical techniques such as flow cytometry, microscopy, biochemical assays and cell functional assays

• Design of Experiments (DOE), and Lean Six Sigma standards

• Software and statistical tools (JMP, Spotfire, SIMCA) for data mining, data analysis, modeling and statistical process control (SPC)

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

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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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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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

Search Firm Representatives Please Read Carefully
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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R321892