Assoc. Dir., Engineering

Job Description

External Manufacturing Large Molecule Drug Substance Technical Lead

Our Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open Associate Director Technical Operations, to support drug substance manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in biologics manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the large molecule line of business at our company. 

Our engineers help ensure that internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Primary responsibilities for this position include, but are not limited to, the following:

• Lead and act as the primary interface on technical issues between technical operations and the external partner.
• Provide technical leadership within the technical operations group for the commercialization and manufacture of drug substance.
• Provides technical guidance to the external partner, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound.
• Collaborates with procurement, external manufacturing operations, external quality, regulatory, and others to evaluate external partner(s) for inclusion in our 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.
• Executes identification and assessment of partner risks and develops mitigation plans.
• 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.
• Supports/coordinates/manages complex investigations, with appropriate interface with other impacted manufacturing sites.
• Provides a technical review of external partner process change requests, deviations, and master batch record changes. Minimizes duplication of efforts between external partner and our systems.
• Drives and supports continuous process verification and process performance monitoring program for all products under his/her responsibility.
• Understands the true regulatory requirements and partners with operations, quality, and the external partner to develop more efficient ways to meet these requirements.

Education and Minimum Requirements:

• Bachelor’s degree in engineering, biological/chemistry sciences or related discipline with a minimum of 10 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer

Required Skills and Experience:

• Minimum of 5 of experience in Drug Substance with experience in leading Drug Substance Technical Transfers and/or commercial manufacturing
• Ability to work effectively across boundaries to build strong collaborative relation with other internal teams, such as; Global Technical Operations, External Services partner groups, and external partners.
• Strong professional and interpersonal communication skills are required.
• Authentic and inclusive people leadership, able to provide examples of your ability to engage and create a psychologically safe and collaborative culture.
• Must be able to multi-task and work within tight deadlines.
• Experience with change control procedures and systems
• Flexibility and the ability to work independently as well as excellent organizational skills.
• Strong knowledge of Quality systems, Drug Substance Manufacturing and Validation.
• Strong analytical problem-solving skills, root cause analysis and risk assessment/mitigation
• Excellent command of English (both written and oral).
• Travel will be a requirement of this position up to 10-20%

Preferred Experience and Skills:

• Experience in mAb DS production.
• Experience in conjugation processes.
• Lean Manufacturing / Six Sigma Experience
• Project management experience
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.

Required Skills:

Preferred Skills:

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