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.
We are seeking individual contributors with strong scientific and technical skills to support development and commercialization activities supporting multiple vaccine programs in late stage development.
In this role, the successful candidate will be responsible for:
- Function as a key member of the team 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
- Contribute to and/or author 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)
- As an individual contributor, will have clearly identifiable elements or functions within a larger project team. May oversee and coordinate work performed by contractors.
Education Minimum Requirement
- B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 2+ years of relevant experience; or
- Master's degree with 1+ 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 correlate to 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 fermentors, 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.
- Proven ability to work independently and as a part of a team, executing against key commitments.
- Ability to foster a collaborative 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.
Preferred Experience And Skills
- Knowledgeable in Drug Substance, end-to-end process development, including microbial, live virus vaccine, gene therapy, or oncolytic virus processes.
- Upstream process development and manufacturing sciences knowledge.
- Experience in current Good Manufacturing Practices (cGMP), Quality by Design (QbD) and Lean Six Sigma principles.
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Requirements
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”.
The salary range for this role is
$85,600.00 - $134,800.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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
Accountability, Accountability, Biochemistry, Biomedical Engineering, Biopharmaceuticals, Cell Cultures, Cell Culture Techniques, Chemical Engineering, Clinical Manufacturing, Communication, Data Analysis, Detail-Oriented, Downstream Process Development, Experimentation, Gene Therapy, Good Manufacturing Practices (GMP), Immunochemistry, Interdisciplinary Collaboration, Maintenance Supervision, Mammalian Cell Culture, Microbiology, Pharmaceutical Process Development, Product Formulation, Production Process Development, Social Collaboration {+ 4 more}
Preferred Skills
Job Posting End Date:
09/24/2025
- 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:R365561
