Posted: 18 June
The role
Job Description
Join our Large Molecule Technical Operations Unit as an Associate Director Technical Operations. This role offers an exciting opportunity to work with key strategic external partners, grow technical experience in biologics manufacturing, and contribute to high visibility network initiatives. Our team is dedicated to providing technical excellence and being strong partners, collaborators, and leaders within the large molecule line of business at our company.
Responsibilities
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.
Provide technical guidance to the external partner, assess the 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 our 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.
Execute identification and assessment of partner risks and develop mitigation plans.
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.
Support, coordinate, and manage complex investigations, with appropriate interface with other impacted manufacturing sites.
Provide a technical review of external partner process change requests, deviations, and master batch record changes. Minimize duplication of efforts between external partner and our systems.
Drive and support continuous process verification and process performance monitoring program for all products under responsibility.
Understand the true regulatory requirements and partner with operations, quality, and the external partner to develop more efficient ways to meet these requirements.
Qualifications
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.
Minimum of 5 years 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 relationships with other internal teams, such as Global Technical Operations, External Services partner groups, and external partners.
Strong professional and interpersonal communication skills.
Authentic and inclusive people leadership, with examples of the ability to engage and create a psychologically safe and collaborative culture.
Ability 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 20%.
Preferred
Experience in mAb DS.
Lean Manufacturing / Six Sigma Experience.
Project management experience.
Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.
Job Details
Employee Status: Regular
Relocation:
VISA Sponsorship:
Travel Requirements: up to 20%
Flexible Work Arrangements: Hybrid
Shift:
Job Posting End Date: 06/23/2026
The job posting is effective until 11:59:59 PM 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.
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