Upper Gwynedd Township, Pennsylvania, United States
Onsite
Job Description
Our Scientists and Engineers support internal development and internal/external manufacturing operations to remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Scientists have opportunities across many areas including Biological, Chemical, Automation, Safety, Technical Services, Process Development, Analytical, Regulatory, and Quality.
As part of Our Company’s Manufacturing Division, within the Biologics Drug Substance Commercialization (BDSC) organization, the upstream process science and technology 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. The group supports various cell bank and upstream drug substance process commercialization activities and second generation process development including cell banks, 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 Director, and working in conjunction with internal and external partners, this person will support mid-late stage and commercial cell bank-related projects for large molecule programs. The person will be responsible for commercialization activities on late-stage pipeline and/ or post-market commercial manufacturing working cell banks for biologics and/or vaccines. Activities include cell bank process assessments and transfers, manufacturing investigations and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across programs.
Technical scope:
Direct projects focusing on cell bank process risk assessments, documentation, process characterization, technology transfer and qualification of new cell banks with line-of-sight for licensure and commercialization.
Responsible for planning and executing work to support commercialization of working cell banks, identification and implementation of process changes for replenishment lots, control strategies, manufacturing operations, investigation evaluations, and regulatory filings.
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.
Collaborate with research and commercial teams to deliver process documentation packages, review batch records, support technology transfer activities, and provide investigation support for cell bank manufacturing, both within our Company network and at contract manufacturing organizations (CMOs).
Author required regulatory and technical documentation associated with cell bank process transfer, long term storage stability, qualification and licensure. Ensure that process/product are developed and documented according to standard company practices. Support regulatory queries and inspections as required.
Provide technical leadership in the assessment of program-specific cell bank processes, interpretations of cell bank performance, as well as qualification approaches across programs. Implement and sustain technical standardization of best practices across the network.
Lead assignment execution against accelerated timelines, in a right-first-time manner, with a “safety first, compliance always” mindset.
Minimum Required Education and Experience:
Bachelor’s Degree in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or a related field with five (5) years of cell culture experience in pharmaceutical industry; OR
Master’s degree in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or a related field with three (3) years of cell culture experience in pharmaceutical industry; OR
Ph.D. in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or a related field with no industry experience.
Required Expertise and Skills:
Fundamental understanding of cell line development, cell culture growth metabolism, cell death, and media adaptation.
Hands-on experience and expertise in mammalian and/or microbial, adherent and/or suspension cell culture, including cell enumeration and expansion, virus infection, cryopreservation, cell bank preparation, and laboratory scale process operations in cell culture stacks, shake flasks
Expertise in upstream lab scale experimental execution, Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions.
Outstanding communication and people skills. Ability to foster a collaborative work environment, focused on common goals and working across boundaries.
Acute problem-solving skills, project management, and keen ability to navigate work in an ambiguous environment.
Preferred Expertise and Skills:
Large molecule process development, including laboratory and/or GMP manufacturing of upstream processes.
Working understanding of US/EU regulatory requirements and analytical methods required to ensure viral safety and characterization of cell banks, and working knowledge of cGMP principles and regulations.
Experience authoring technical documentation to support regulatory submissions.
Hands-on expertise with mammalian cell culture bench scale and ability to oversee teams through these requirements as lab lead.
Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, manufacturing batch record reviews and/or operations.
Expertise with 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).
Required Skills:
Biologics, Biology, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Design of Experiments (DOE), Good Manufacturing Practices (GMP), Mammalian Cell Culture, Process Development (PD), Process Scale Up, Regulatory Submissions, Technology Transfer, Upstream ProcessingPreferred Skills:
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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.
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The salary range for this role is
$117,000.00 - $184,200.00This 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:
YesTravel Requirements:
25%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
09/17/2026*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.
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