Associate Principal Scientist, Engineering- Cell Culture Sciences, Biologics Drug Substance Commercialization

Job Description

We are seeking a strategic and technical leader with expertise in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, second generation process development and authoring of regulatory submissions.

Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule biologics program activities. The individual will be responsible for leading a team to support development activities, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing 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

In this role, the successful candidate will be responsible to

• Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.

• 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 process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.

• Manage large multifaceted projects as the leader of a cross-functional team.

• Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.

• Monitors performance and recommends schedule changes, cost adjustments or resource additions.

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

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

• May be responsible for managing large multifaceted projects as the leader of a cross-functional team.

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

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

Minimum Education Requirement and Experience:

• Bachelors degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of relevant industry experience

OR

• Masters degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of of relevant industry experience

OR

• Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of of relevant industry experience

Required Experience and Skills:

• Strong fundamental knowledge and subject matter expertise with mammalian 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 all stages of cell culture process commercialization.

• Experience with 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), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.).

• 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.

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

• Demonstrated commitment and experience to coach and mentor staff to maximize talent development and utilization.

• Excellent interpersonal and communication skills

Preferred Experience and Skills

• Experience in leadership of CMC development teams.

• Experience with cell culture process development for biologics.

• Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control

• Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.

• Background in data science approaches related to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts)

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

• Experience with mathematical modeling, theoretical scaling calculations, drug substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, 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 salary range for this role is

$139,600.00 - $219,700.00

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 employees 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 .

You can apply for this role through (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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Bioprocessing, Communication, Decision Making, Detail-Oriented, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, People Management, Process Improvements, Protein Purifications, Science, Technical Writing

Preferred Skills:

Biologics, Cell Culture Process Development, Cell Cultures, Commercialization, Mammalian Cell Culture, Technology Transfer

Job Posting End Date:

06/28/2025

*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.