Associate Director (Engineering), Biologics External Manufacturing Technical Operations

About this role

Job Description

We aspire to be the premier research-intensive biopharmaceutical company. At the forefront of research, we deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and be part of a company that uses the power of leading-edge science to save and improve lives around the world.

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. 

Responsibilities • 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. • 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. • Provide 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. • Collaborate with Procurement, External Manufacturing Operations, External Quality, Regulatory, and others to evaluate External Partner(s) for inclusion in the Company Network. 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 provide guidance on process and capacity optimization. • 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 for all products under responsibility. • In concert with Commercialization, Quality, and Regulatory, ensure that External Partner(s) are inspection ready for all new product introductions and transfers. • Understand the true regulatory requirements and partner with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements. • Collaborate with External Partners to achieve business goals and establish a common culture that benefits both our company and EP.

Qualifications Required • A Bachelor’s degree in Engineering, Science, or Business. • 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. • Expertise and demonstrated accomplishments leading technical transfers. • Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues. • Excellent leadership, collaboration, change management, interpersonal, analytical skills, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written).

Preferred • An advanced degree in Engineering, Science, or Business. • Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s). • Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements. • Ability to motivate a team around a common vision and deliver expected results. • Creative, innovative, self-motivated, apply problem-solving skills, and solid base in engineering fundamentals and process troubleshooting. • Experience in complex international environment with matrix organization structures. • Experience in Large Molecule unit operation design, startup, and/or operation.

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

Required Skills: Ability to Coordinate, Ability to Coordinate, Adaptability, Automation Systems, Biologics, Capital Project Management, Change Management, Clinical Manufacturing, Competency Development, Contract Manufacturing, Data Analysis, Decision Making, Drug Product Manufacturing, External Manufacturing, Interpersonal Relationships, Lateral Thinking, Lean Manufacturing, Manufacturing Scale-Up, Matrix Management, Partner Relationship Management (PRM), Problem Identification, Process Alignment, Productivity Improvements, Regulatory Compliance, Regulatory Management {+ 11 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 capabil

Similar jobs

• Associate Director, Technical Operations, Biologics Drug Substance Manufacturing — Travere Therapeutics · Remote
• Associate Director, Technical Operations (Analytical Development-Biologics) — Travere Therapeutics · Remote
• Associate Director, Technical Operations - Drug Product — Travere Therapeutics · Remote
• Associate Director, GMP Operational Quality (Biologics and Devices) — Vertex · Boston, MA
• Associate Director, Bioreactor Process Design — Evotec · Redmond
• Associate Director of Engineering, Small Molecule Process Development and Manufacturing — Biibhr · Cambridge, MA
• Associate Director, Drug Product Manufacturing — Dynetherapeutics · Waltham, MA
• Senior Biologics Manufacturing Technical Expert — Gilead Sciences · Foster City, California, United States