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About the Role

The Associate Director, Engineering within Biologics External Manufacturing Technology will serve as the key technical leader interfacing between the company and External Partners for the Biologics External Manufacturing (ExM) organization. This role is critical for creating, leading, and executing technical transfers and commercial supply from External Partners, ensuring excellence in Compliance, Supply, Continuous Improvement & Cost Reduction.

Responsibilities

Create, lead, and execute technical transfers to and commercial supply from External Partner(s).
Collaborate across multiple technical functions to ensure successful technical transfer and commercial manufacture with External Partner(s).
Lead several high-impact, complex, cross-functional divisional teams.
Provide technical and project leadership to Biologics External Manufacturing business.
Provide a single point of technical contact to assigned External Partners, impacted Company Manufacturing Division sites, and Commercialization.
Provide technical oversight, management, and planning support for complex partnership models.
Independently provide coordination, communication, and oversight of assigned External Partner technical issues.
Accountable for overall tech transfer delivery (on-time, within budget), working closely with Operations Unit leadership to assure resourcing.
Provide technical guidance to the External Partner, assess technology viability, verify adherence to standards, and ensure deliverables are technically sound.
Collaborate with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate External Partner(s).
Execute technical due diligence assessments at External Partner(s).
Ensure tech transfers are positioned for successful business outcomes.
Execute technical transfers and receiving site readiness activities.
Lead team for identification and assessment of partner risks and develop mitigation plans.
Develop and execute validation strategies for new and existing products.
Provide manufacturing process support to External Partner(s) to resolve production issues and optimize processes and capacity.
Ensure targeted communications and alignment across technical functions.
Guide and coach others in change leadership.
Support/Coordinate/Manage complex investigations with appropriate interface with other impacted manufacturing sites.
Determine resource plans across all relevant technical functions.
Provide a technical review of External Partner process change requests, deviations, and Master Batch Record changes.
Minimize duplication of efforts between External Partner and Company systems.
Drive and support Continuous process verification and process performance monitoring program.
Ensure External Partner(s) are inspection ready for all new product introductions and transfers in concert with Commercialization, Quality, and Regulatory.
Understand regulatory requirements and partner with Operations, Quality, and the External Partner to develop efficient ways to meet them.
Collaborate with External Partners to achieve business goals and establish a common culture.

Requirements

A Bachelor’s degree in Engineering or applicable Science is required.
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.
Expertise and demonstrated accomplishments leading technical transfers 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 and flexibility in partner assignment location is required; assignments may require short term travel assignments.
US and Puerto Rico Residents Only.
San Francisco Residents Only: Will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only: 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.

Skills

Biologics manufacturing experience
Broad process sciences and analytics
Strong leadership skills
Business acumen
Interpersonal 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
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.

Location

US is flexible
Northern California
Company's Sites in the US

Work Type

Remote
50% Travel

Experience Level

Associate Director
8 years post-bachelor’s degree experience

Education Level

Bachelor’s degree in Engineering or applicable Science
Advanced degree in Engineering, Science, or Business is preferred

Salary/Compensations

$142,400.00 - $224,100.00

Benefits

Eligible for annual bonus and long-term incentive, if applicable.
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.

About the Company

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century.
Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
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.

Equal Opportunity

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