Assoc. Dir., Engineering

MSD•Town of Italy, NY

7h•Hybrid

About The Position

Our Large Molecule Technical Operations Unit is seeking a highly motivated leader to become the Technical lead for the ADC Drug Substance manufacturing within our External Manufacturing Network. This is an exciting opportunity to support commercialization of our Company`s growing ADC/Bioconjugation pipeline, work with key strategic external partners, lead a high performing team 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:

Requirements

Understands the true regulatory requirements and partners with operations, quality, and the external partner to develop more efficient ways to meet these requirements.
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 of experience in Bioconjugation/ADC DS manufacturing.
Experience in leading Technical Transfers and Commercial Manufacturing.
Proven people management experience with a focus on developing and coaching high performing teams.
Authentic and inclusive people leadership, able to provide examples of your ability to engage and create a psychologically safe and collaborative culture.
Ability to work effectively across boundaries to build strong collaborative relation with other internal teams, such as; Quality, Operations, Commercialisation, External Services partner groups, and external partners.
Strong professional and interpersonal communication skills are required.
Must be able to multi-task and work within tight deadlines.
Flexibility and the ability to work independently as well as excellent organizational skills.
Extensive knowledge of Bioconjugation Chemistry, 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).

Nice To Haves

Lean Manufacturing / Six Sigma Experience
Project management experience
Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.
Italian and/or German

Responsibilities

Lead and act as the primary interface on technical issues between technical operations and the external partner.
Provide technical leadership for Tech Transfers and commercial manufacturing of ADC drug substance.
Lead a high performing team of Technical Operations Engineers who are supporting tech transfers and commercial mfg of different ADC molecules.
Provides technical guidance to the external partners, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound.
Executes identification and assessment of partner risks and develops mitigation plans.
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).
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.