Associate Director, Engineering (Onsite)

Job Description

Title: Associate Director, Engineering

Job Description:

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough.

Seeking a candidate for a leadership position in our Research & Development Division Biologics Pilot Plant (BPP) Process Operations Team.  We are recruiting a highly motivated and experienced person to Lead end-to-end program management for clinical manufacturing campaigns, with a focus on campaign preparation and closeout execution. The candidate will drive cross-functional alignment across Process Development, Quality, Supply Chain, and Manufacturing to ensure timely drug substance release, and oversee coordination of material transfer to downstream sites, ensuring readiness and alignment with clinical timelines. This candidate will work to identify and mitigate risks impacting delivery to proactively driving resolution across stakeholder groups.

In this position, you will exemplify our company's leadership qualities by demonstrating integrity in all interactions, fostering a culture of innovation by encouraging creative solutions within your team, and embracing collaboration across functions to achieve common goals. You will hold yourself and your team accountable for delivering results, while also considering the long-term impacts of your decisions on our community and the environment. Additionally, you will champion diversity and inclusion by building a well-rounded team of subject matter experts, ensuring multiple perspectives contribute to our manufacturing processes.

Key Responsibilities:

• Partner with the process leadership team drive operational excellence for right-first-time (RFT) batch execution on the manufacturing floor.

• Collaborate with cross-functional teams to ensure agile pipeline deliverables are met

• Manage end to end timelines of clinical campaigns coming in and out of the pilot plant through preparation, execution, and close out

• Develop and implement a comprehensive training vision and strategy for Process Operations, aligned to BCMT and enterprise goals

• Design scalable onboarding frameworks to enable rapid ramp-up of new process engineers while maintaining compliance and quality standards

• Integrate innovative training approaches (e.g., prep sessions, digital content, external partnerships) to enhance learning effectiveness

• Champion a culture of accountability, collaboration, and continuous improvement

• Provide leadership oversight and approval for process-related Quality Notifications (QNs), Change Requests (CRs), and Standard Operating Procedures (SOPs)

• Ensure all process changes are technically sound, compliant, and aligned with long-term Process Operations strategy

Education Minimum Requirement:

BS or MS degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry.

Required Experience and Skills:

• A highly motivated individual with the ability to work in a fast-paced and dynamic environment

• Demonstrated ability to mentor team members and influence cross-functional groups

• Technical knowledge of fermentation and cell culture processes, including aseptic techniques, live virus handling, BSL2 practices, cleanroom protocols, and bioprocessing equipment

• Technical knowledge in purification processes such as chromatography, tangential flow filtration (TFF), and dead-end filtration

• Knowledge of the considerations required for transitioning from development to GMP (Good Manufacturing Practice) environments and influencing necessary adaptations

• Strong understanding of cGMP (current Good Manufacturing Practices), quality systems, and safety protocols within operations

• Hands on bioprocess experience either through labs or operations

• Previous experience in leading projects in either process development or GMP environments

• Understanding technical writing specifically for investigations and deviations

• Understanding of developing and leading a training program to support a GMP area

Preferred Experience and Skills:

• Excellent organizational and problem-solving abilities

• Capability to work both independently and collaboratively, delivering strong results

• Exceptional conflict management and negotiation skills

• Strong communication skills paired with personnel development aptitude

• Prior management experience, or experience leading teams

• Experience with SAP inventory management system and/or SAP QN

·         Demonstration of Decision Making, Execution Excellence, Innovation, and Change Catalyst Leadership Skills

#eligibleforERP

#PRD

Required Skills:

Adaptability, Adaptability, Biopharmaceutical Industry, Biopharmaceutics, Cell Cultures, Chemical Engineering, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, Fast-Paced Environments, GMP Compliance, Good Manufacturing Practices (GMP), Mammalian Cell Culture, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Safety Compliance, Safety Protocols, SAP Inventory Management, Strategic Thinking {+ 2 more}

Preferred Skills:

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 salary range for this role is

$142,400.00 - $224,100.00

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 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/14/2026

*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.