Apply on Employer Site

Merck · 2 days ago

Assoc Prin. Scientist, Engineering

Rahway, NJ

Full-time

Hybrid

Senior Level, Lead/Staff

$140K/yr - $220K/yr

6+ years exp

Merck is a leading company in the pharmaceutical industry, and they are seeking a Biologics Cell Culture Commercialization Leader to enhance their biologics pipeline. This role involves providing strategic direction, overseeing cell culture process development, and leading cross-functional teams to ensure successful commercialization of biologics.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Technical Strategy: Deliver robust DS strategies for successful commercialization. Provide technical oversight of cell culture 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

Technical leadership: 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. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions

CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA)

Leadership: Establish, manage and support Cell Culture CMC teams, and align resources to deliver on priorities. Manage and mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff.   Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve

Cross-Functional Collaboration: Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams

Problem Solving: Remove roadblocks, resolve conflicts, and escalate issues when needed

Communication: Foster collaboration, ensure transparency, and engage with governance bodies.  Excellent interpersonal and communication skills

Project Management: Drive project schedules, set clear priorities, and monitor performance metrics. Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment

Recognition: Celebrate team achievements and foster a culture of appreciation

Innovation: Lead business improvement initiatives and leverage your network to drive change

Qualification

Cell CultureRegulatory SubmissionsBioprocessingTechnical LeadershipManufacturing Process ValidationRisk ManagementMammalian Cell CultureProject ManagementData AnalysisInnovationManufacturing Quality ControlManufacturing Scale-UpProcess ImprovementsStakeholder EngagementTechnology TransferAdaptabilityCross-Functional TeamworkDecision MakingDetail-OrientedMentorshipTechnical Writing

Required

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

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

Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum three (3) years or relevant industry experience

Proven leadership of functional teams in biologics development & commercialization

Deep expertise in cell culture commercialization and manufacturing operations

Strong understanding of regulatory requirements

Ability to lead without authority, build trust, and inspire accountability

Ethical, resilient, and committed to excellence

Skilled in risk management, team facilitation, and strategic planning

Experience in commercial manufacturing and CMC development

Exceptional communication and stakeholder engagement skills

Technical Strategy: Deliver robust DS strategies for successful commercialization

Technical leadership: Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products)

Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization

Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions

CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA)

Leadership: Establish, manage and support Cell Culture CMC teams, and align resources to deliver on priorities

Manage and mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff

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

Cross-Functional Collaboration: Unite diverse teams to achieve program goals as One Team

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

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

Problem Solving: Remove roadblocks, resolve conflicts, and escalate issues when needed

Communication: Foster collaboration, ensure transparency, and engage with governance bodies

Excellent interpersonal and communication skills

Project Management: Drive project schedules, set clear priorities, and monitor performance metrics

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

Recognition: Celebrate team achievements and foster a culture of appreciation

Innovation: Lead business improvement initiatives and leverage your network to drive change

Required Skills: Accountability, Adaptability, Bioprocessing, Cell Cultures, Chemical Engineering, Cross-Functional Teamwork, Data Analysis, Decision Making, Detail-Oriented, Innovation, Mammalian Cell Culture, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements, Project Management, Regulatory Submissions, Risk Management, Stakeholder Engagement, Technical Leadership, Technical Writing, Technology Transfer