Director, Engineering

Job Description

We are seeking a strategic and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 10-15 scientists in Rahway NJ, who lead multidisciplinary program teams and execute laboratory activities. 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 Head of Biologics Cell Culture Sciences 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 of scientists to support development activities, commercialization activities of the late-stage biologics pipeline and post-market commercial manufacturing support for commercial biologic products.

This challenging position requires a clear vision for team development, demonstrated leadership skills, critical thinking abilities, effective technical and communication skills, deep cell culture subject matter expertise, a strong understanding of drug commercialization and the regulatory landscape.

In this role, the successful candidate will be responsible to

• Manage and mentor a team of scientists specializing in biologics commercialization, serving 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.
• Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.
• Provide technical oversight of 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 and/or mentor leaders of large multifaceted projects of cross-functional teams.
• 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.
• Champion compliance and safety; promote a culture of diversity, inclusion, and equity.

Minimum Education Requirements and Experience:

• Bachelor’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with fourteen (14) years of combination of experience including team management, technical expertise in cell culture, and regulatory knowledge in the pharmaceutical industry. OR
• Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with twelve (12) years of combination of experience including team management, technical expertise in cell culture, and regulatory knowledge in the pharmaceutical industry. OR
• Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of combination of experience including team management, technical expertise in cell culture, and regulatory knowledge in the pharmaceutical industry.

Required Experience, Skills and Competencies:

• Three or more (3+) years’ experience managing a team of scientists; completing people management responsibilities including both performance and talent management activities
• Demonstrated ability in leading teams with proven talent development skillsets.
• 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.
• Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
• Proven leadership and project management skills to drive initiatives and team performance.
• 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.
• Excellent interpersonal and communication skills

Preferred Experience and Skills

• Multi-year experience with cell culture process development for large biologics products.
• 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. 

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:

EEOC Know Your Rights

EEOC GINA Supplement​

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 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 candidate’s relevant skills, experience, and education.

Expected US salary range:

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 listedhere.

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: