Senior Scientist, Engineering

Merck; Pennsylvania; Hybrid; USD 90,000 - 120,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a skilled individual to lead and execute upstream process development for vaccine programs. The ideal candidate will have a strong background in chemical or biochemical engineering and experience in large molecule processes. Responsibilities include lab-scale experiments, technical documentation, and collaboration with manufacturing teams. The role emphasizes mentorship and teamwork in a hybrid work environment.

Qualifications

• 6+ years of relevant experience with a B.S. or 4+ years with a Master's.
• Experience with large molecule process development and tech transfer.

Responsibilities

• Lead large molecule upstream process development activities.
• Collaborate with commercial manufacturing teams for facility start-up.
• Provide mentorship and technical direction to team members.

Skills

Adaptability

Communication

Data Analysis

Detail-Oriented

Education

B.S. in Chemical Engineering

Master's degree

Ph.D.

Tools

Computational Fluid Dynamics (CFD)

Chromatographic Techniques

Job description

Job Description

As part of Our Company’s Manufacturing Division, within the Vaccines Drug Substance Commercialization (VDSC), the Upstream department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for the upstream portion of vaccines drug substance processes. VDSC supports various commercialization activities, early and late-stage process development, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.

Weare seeking individual contributors withstrong scientific and technical skills to lead development and commercialization activities supporting multiple vaccine programs in late-stage development.

In this role, the successful candidate will be responsible for:

• Leading and executing large molecule upstream process development activities including lab-scale process development and process scale-up/scale-down.

• Executing lab scale experiments and authoring associated technical reports and documents.

• 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.

• Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within our Company's network and at contract manufacturing organizations (CMOs).

• Providing mentorship, coaching, and technical direction to other members of the team which may include direct reporting relationships.

Education Minimum Requirement:

• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 6+ years of relevant experience; or

• Master's degree with 4+ years of relevant experience; or Ph.D. with relevant experience.

Required Experience and Skills:

• Large molecule process development, or relevant experience including scaling (up and down) and tech transfer/facility fit of large molecule drug substance processes

• Good understanding of microbial physiology and metabolism and ability to correlateto in-lab or shop floor fermentation events

• Experience with small, lab, or pilot-scale large molecule fermentation and cell culture processes such as use of fermenters, bioreactors, and/or static cell culture

• Expertise in lab scale experimental execution and experience with statistical data analysis (JMP, PI Vision, Spotfire, SIMCA, etc.) including presentation of results/conclusions.

• Experience with authoring technical documentation.

• Outstanding communication and people skills.

• Ability to foster a collaborative work environment focused on mentorship, coaching, and learning.

• Experience with project strategic planning.

• Outstanding communication and people skills.

• 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.

Preferred Experience and Skills:

• Knowledgeable in Drug Substance, end-to-end process development, including microbial, live virus vaccine, gene therapy, or oncolytic virus processes.

• Experience with upstream unit operation mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling.

• Experience with Quality by Design (QbD) and Lean Six Sigma principles

• Ability to provide scientific mentorship and guidance to technical coworkers

• Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA)

• Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Biochemistry, Biomedical Engineering, Biopharmaceuticals, Biopharmaceutics, Bioreactors, Business, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Communication, Computational Fluid Dynamics (CFD), Computational Fluid Dynamics (CFD) Simulation, Data Analysis, Design of Experiments (DOE), Detail-Oriented, Gene Therapy, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, Mammalian Cell Culture, Manufacturing Processes {+ 16 more}

Preferred Skills:

Job Posting End Date:

05/27/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R349059