Associate Director, Engineering

HireLifeScience; Stockton (CA); Remote; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision

Job summary

HireLifeScience is seeking an Associate Director, Engineering within Biologics External Manufacturing Technology to lead technical transfers to external partners and act as the primary technical contact for external collaborations.

The role, based on the US West Coast, requires coordinating across multiple functions to ensure on-time, within-budget transfer delivery and support for vaccines and biologics manufacturing, with significant leadership responsibility.

Qualifications

• Experience leading technical transfers.
• Leadership of cross-functional teams in manufacturing.
• Lean manufacturing expertise for productivity improvements.
• Strong problem-solving and communication skills.
• Experience with biologics or large molecule processes preferred.

Responsibilities

• Provide a single point of technical contact to External Partners and sites.
• Oversee technical transfer delivery, on-time and within budget.
• Collaborate with procurement, External Manufacturing, QA, and Regulatory.
• Develop validation strategies for new and existing products.
• Lead risk assessments and mitigate partner-related risks.
• Support continuous improvement and process performance monitoring.

Skills

Technical leadership

Technical transfers

Cross-functional leadership

Lean manufacturing

Problem solving

Education

Bachelor's degree in Engineering or applicable Science

Master's degree preferred

Job description

Job Description

General Summary: -

Due to continued growth and investment, our company is hiring-an Associate Director, Engineering within Biologics External Manufacturing Technology.--

The Associate Director will-be the key technical leader interface between our company and External Partners-for the Biologics External Manufacturing-(ExM)-organization.----

This individual will create, lead and execute technical transfers to and commercial supply from External Partner(s).-The candidate will be based in the US on the west coast and report to the Director, Biologics-External Manufacturing-Technology.---

The-ideal-candidate will be someone who can navigate a complex network of drug substance nodes across biologics modalities and tech support models.-The-candidate needs to collaborate across multiple technical functions to ensure the success technical transfer and commercial manufacture with the-External-Partner(s).-This individual will be capable of leading several high-impact, complex, cross-functional divisional teams and will provide significant leadership to the department.-This role is critical to the organization's ability to support new and in-line commercial product technology transfers to-External-Partnerships, and support of our in-line products, with sharp oversight and technical risk management, focus on the rapidly expanding biologics third party network.

Position Profile:

The-Associate Director, Engineering within Biologics External Manufacturing Technology-is accountable for achieving excellence in Compliance, Supply, Continuous Improvement & Cost Reduction in partnership with our internal technical partners and-External Partner (EP)-leadership, supporting the Vaccines and Biologics businesses.- This individual works in collaboration with the-Focus Factory Operations lead,-modality specific-Technology-Leads, Large Molecule External Quality Assurance, and Procurement.---The Associate Director must have biologics manufacturing experience, with broad process sciences and analytics, strong leadership skills, business acumen, and interpersonal skills.

Job Details:

• Provides-a single point of technical contact to assigned External Partners, impacted Company Manufacturing Division sites,-and Commercialization.---
• Provides-technical oversight, management, and planning support for complex partnership models.- Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues-
• Accountable to External Manufacturing for overall tech transfer delivery (on-time, within budget), working closely with the Operations Unit leadership to assure resourcing for each activity.-
• Provides-technical guidance-to the-External-Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.---
• Collaborates with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate-External-Partner(s)-for inclusion in the-Company-Network.- Executes technical due diligence assessments at-External-Partner(s).-
• Ensures-tech transfers are positioned for successful business outcomes.-- Executes technical transfers-and-receiving site readiness activities.-
• Leads team for identification and assessment of partner-risks and develops mitigations plans.---
• Develops and executes validation strategies for new and existing products.-
• Provides-manufacturing process support to-External-Partner(s)-to resolve production issues and to provide guidance on process and capacity optimization.-----
• Ensures-targeted communications and alignment across technical functions.- Guides and coaches' others in change leadership.---
• Support/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites-
• Determines-resource plans across all relevant technical functions.---
• Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes.--Minimizes-duplication of efforts between External Partner and Company-systems.-
• Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility-
• In concert with Commercialization, Quality, and Regulatory, ensures that-External-Partner(s)-are inspection ready for all new product introductions and transfers.-
• Understands the true regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.---
• Collaborates with External Partners to achieve business goals and to establish a common culture that benefits both Our Company-and EP.-

Education Requirements:

• A Bachelor's degree in Engineering or-applicable-Science is required.- An advanced degree in Engineering, Science, or Business is preferred.-
• Minimum of-8 (eight) years post-bachelor's degree experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing,-engineering,-and/or technical support of operations is required-

Skill Requirements:

• Expertise and demonstrated accomplishments leading technical transfers is required-
• Experience in leading cross-functional teams in support of manufacturing operations at internal sites or-External-Partner(s)-is preferred-
• Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements is preferred-
• Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues is required-
• Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration,-and engagement as a team player with dependable interpersonal and communication skills (both-verbal and written) is required.---
• Ability to motivate a team around a common vision and deliver expected results is preferred.-
• Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and process troubleshooting-is preferred-
• Experience in complex international environment with matrix organization structures is preferred-
• Experience in Large Molecule unit operation design, startup, and/or operation is preferred.

Travel Requirements:

>>30% for partner assignments outside of primary location-(primarily traveling within designated EU region). Travel and flexibility in partner assignment location is required; assignments may require short term travel assignments.

Location:

Location US is flexible.- Position may be based in Northern California or our company's Sites in the US

Reporting Structure:

This role will report to the Director, Biologics External Manufacturing Technology-

Required Skills:

Adaptability, Automation Systems, Capital Project Management, Change Management, Clinical Manufacturing, Data Analysis, Decision Making, Drug Product Manufacturing, Interpersonal Relationships, Lean Manufacturing, Manufacturing Scale-Up, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Technical Transfer

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 another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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 .

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

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/13/2026

*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.

Requisition ID:

R402154