Job Description
Our Engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
As part of Our Company's Manufacturing Division, within the Biologics Drug Substance Commercialization (BDSC), our team provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. BDSC 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 Principal Scientist in the BDSC group and working in conjunction with internal and external partners, this person will support late stage and commercial large molecule program activities. The person will be responsible to support development activities, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing vaccines and biologics. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring.
Technical scope:
- Directs project team focusing on process characterization, technology transfer and validation of biopharmaceutical molecules with line-of-sight for licensure and commercialization.
- Responsible for planning or executing scale studies to support commercial process validation, process characterization, and investigation evaluations, including studies performed either in-house or externally.
- Design, plan, and execute laboratory experiments to generate high quality data. Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports.
- 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 network and at contract manufacturing organizations (CMOs).
- Provides technical leadership in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA). Lead technical investigations and process changes that drive improvements to yield and/or robustness.
- Authors required regulatory and technical documentation associated with process Tech Transfer and validation. Ensures that process/product are developed and documented according to standard company practices.
- Supports regulatory queries and inspections as required.
- Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
Minimum Required Education and Experience:
- Bachelor's Degree in in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with five (5) years of cell culture experience in pharmaceutical industry; OR
- Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with three (3) years of cell culture experience in pharmaceutical industry; OR
- Ph.D. in in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with no experience.
Required Expertise and Skills:
- Large molecule process development, including scaling (up and down) and tech transfer of drug substance processes.
- Expertise in upstream lab scale experimental execution, Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions.
- Expertise authoring technical documentation to support regulatory submissions leading to product licensure.
- Outstanding communication and people skills.Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.
- Working comprehension of analytical methods to characterize large molecules, US/EU regulatory requirements and working knowledge of cGMPs principles and regulations.
Preferred Expertise and Skills:
- Hands-on expertise with mammalian cell culture bench scale and high-throughput bioreactor systems (e.g. 2L,3L, Ambr250) and ability to oversee teams through these requirements as lab lead.
- Expertise with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.
- Expertise with mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles.
Expertise supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).
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:
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
$114,700.00 - $180,500.00This 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Adaptability, Adaptability, Biodesign, Biological Engineering, Biomedical Engineering, Bioreactors, Business, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Communication, Computational Fluid Dynamics (CFD), Design of Experiments (DOE), Detail-Oriented, Good Manufacturing Practices (GMP), Mammalian Cell, Mammalian Cell Culture, Process Characterization, Process Design, Process Optimization, Process Scale Up, Regulatory Requirements, Small Molecule Synthesis {+ 4 more}Preferred Skills:
Job Posting End Date:
06/17/2025*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:R351457