Assoc Prin. Scientist, Engineering

Job Description

As part of Our Companys 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 Associate Principal Scientist, and working in conjunction with internal and external partners, this individual will support mid-late stage and commercial cell bank-related projects for large molecule programs. The person will be responsible for leading workstreams and guiding cell bank projects across programs to support multiple commercialization activities on late-stage pipeline and/ or post-market commercial manufacturing 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.

In this role, the successful candidate will be responsible to

• Coordinate project planning, people, resourcing, progress reporting, and troubleshooting in a matrixed organization.

• Serve as the scientific/technical mentor for junior staff. Provide technical guidance in the various aspects of Cell Culture process development/commercialization for large molecule products.

• Responsible for cell bank process characterization, technology transfer support for internal and external manufacturing sites, laboratory support for investigations, and regulatory filing activities to ensure a smooth and clear path to successful GMP operations and BLA filings for the company's pipeline.

• Leads and/or supports program-specific cell bank qualification strategies for manufacturing. Ensure project results meet requirements regarding technical quality, reliability, schedule, and cost. Implement and sustain the end to end technical standardization of cell bank best practices across the network.

• 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.

• 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).

• Monitor cell bank process performance across programs, support timeline creation and management of work packages within project teams. Monitor and project resource needs to support technical work packages and on time delivery.

• Solve technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.

• Provide timely and accurate information and status updates to project sponsors and management.

• Champion compliance and safety; promote a culture of diversity, inclusion, and equity.

Minimum Education Requirement and Experience:

• Bachelors Degree in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or a related field with eight (8) years of technical expertise in cell culture sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry; OR

• Masters degree in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or a related field with six (6) years of technical expertise in cell culture sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry; OR

• Ph.D. in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or a related field with four (4) years of technical expertise in cell culture sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry

Required Experience and Skills:

• Strong fundamental knowledge and subject matter expertise with mammalian cell banks and cell culture processing of biologics (large molecule products), recent advances, and challenges in the field

• Expertise in independently conducting and directing the planning, execution, analysis, and documentation of cell bank processes, cryopreservation, and all stages of cell culture process commercialization.

• Experience with cell bank manufacturing and fundamental understanding of its integration in late-stage commercial process development (CPD), technology transfer (TT), scale-down model qualification (SDMQ) and process characterization (PC).

• Experience authoring technical documentation in support of the following: process characterization (PC), risk assessment (RA), control strategy, comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.).

• Working understanding of US/EU regulatory requirements and analytical methods required to ensure viral safety and characterization of cell banks, and expert knowledge of cGMP principles and regulations.

• Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.

• Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.

• Customer-focused, action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.

• Excellent interpersonal and communication skills.

Preferred Experience and Skills

• Experience in leadership of cell banking projects and with cell culture process development for biologics and vaccines.

• Experience with cell bank manufacturing operations, cell culture process performance attributes, and analytical testing requirements for cell bank characterization and release.

• Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.

• Experience with cell line development, drug substance comparability, Quality by Design (QbD) and Lean Six Sigma principles.

• Experience 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:

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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 anothers 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 candidates relevant skills, experience, and education.

Expected US salary range:

$139,600.00 - $219,700.00

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

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Biodesign, Biological Engineering, Biomedical Engineering, Bioprocessing, Business, Cell Cultures, Communication, Cryopreservation, Data Analysis, Decision Making, Detail-Oriented, GMP Compliance, Maintenance Supervision, Mammalian Cell, Mammalian Cell Culture, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Characterization, Process Improvements, Protein Purifications, Regulatory Submissions {+ 4 more}

Preferred Skills:

Job Posting End Date:

06/13/2025

*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.