Senior Scientist BioSeparations

Job Description

As part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Bioseparation Sciences (BSS) department provides the technical downstream process leadership and laboratory capabilities in support of late-stage pipeline and commercial drug substance manufacturing processes for vaccines and biologics. BDSC supports second generation process development and various commercialization activities including process characterization, process science support for technology transfer to internal and external manufacturing sites, manufacturing investigation, process validation, and authoring of regulatory submissions.

We are seeking a Senior Scientist to join our team and contribute to late-stage clinical process development, technology transfer, and commercialization efforts. The ideal candidate will have a strong technical background in downstream processing, with a proven ability to drive process and mechanistic models and build digital twins within Industry 4.0 technologies.

Technical Scope and Responsibilities:

• Participate in teams focusing on late-stage clinical process development, characterization, and technology transfer, with a focus on licensure and commercialization.
• Provide technical leadership for the design of experiments, data analysis and interpretation, and the execution or management of laboratory activities.
• Drive process and facility models to support tech transfer and facility fit.
• Focus on downstream processing, with emphasis on process models, digital twins, and Industry 4.0.
• Actively engage with internal and external partners and represent the functional area on cross-functional teams and external collaborations.
• Author BLA regulatory filings and technical documentation
• Support validation of new software and technologies validation for GMP application
• Ensure digital solutions are deployed in conjunction with existing process monitoring.
• Represent the function in global digital programs and cross-functional digital initiatives.

Education Minimum Requirement:

• MSc (3+ years of experience), Ph.D. or equivalent degree in Chemical Engineering, Biochemistry or a relevant scientific or engineering discipline.
• Significant experience in downstream process development within the biopharmaceutical industry.
• Proven expertise in process modeling, digital twins, and Industry 4.0 technologies.
• Strong leadership and project management skills.
• Excellent communication and collaboration abilities.

Required Experience and Skills:

• Technical background in purification of large biological molecules, including laboratory techniques for chromatography and filtration systems.
• Hands-on experience in small-scale laboratory downstream process.
• Deep understanding of process modeling methodologies and proficiency in modeling software such as Cadet, Gproms, GoSilico, Aspen or others.
• Capable of designing model calibration experiments and validating the models using laboratory experimental data.
• Excellent oral and written communication skills. Demonstrated ability to effectively articulate understanding of process science to drive decision-making, impact assessments, design of studies, and other activities in a multi-disciplinary team environment.

Preferred Experience and Skills:

• Experience with downstream purification of large biological molecules required, with in-depth knowledge of preparative chromatography, tangential flow filtration, and virus-retaining filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations is a must.
• Experience with mechanistic models and digital-twin concepts and application.
• Prior experience with automation systems and IOT (Internet of Things).
• Prior experience in late-stage process development, process characterization including viral clearance studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organizations for development and/or manufacturing.
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
• Business Knowledge: High performance in delivery of work. Looks for better, simpler ways, takes initiative and runs proactively with actions.
• Demonstrated self-management, prioritization, and organizational skills.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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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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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".

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:
$111,400.00 - $175,300.00

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

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:
Regular

Relocation:
Domestic/International

VISA Sponsorship:
Yes

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
01/4/2025
*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:R316586