Associate Director, Technical Operations - Small Molecule Drug Substance

BioSpace; Stuarts Draft (VA); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

BioSpace is seeking an Associate Director, Technical Operations – Drug Substance at our Elkton Site in Virginia. The role provides technical leadership for startup, technology transfer, validation, and ongoing commercial manufacture of APIs, ensuring safe, compliant, and reliable process performance.

Responsibilities include leading scale-up, process validation, and continued process verification, with a focus on yield improvement, impurity control, and cross-functional governance across

Formación

• BSc/BEng/Masters in Chemistry or Chemical Engineering or related field.
• 10+ years in API process development or manufacturing.
• Strong analytical, problem-solving, and communication skills.

Responsabilidades

• Provide technical leadership for startup, technology transfer, validation, and ongoing manufacture of APIs.
• Lead scale-up, regulatory readiness, and process validation across assigned processes.
• Drive continuous improvement in yield, cycle time, and impurity control.
• Support CAPA, deviations, OOS investigations with root-cause analysis.
• Collaborate with Engineering, R&D, Quality, and Manufacturing teams.

Conocimientos

Technical leadership

Cross-functional collaboration

Regulatory understanding

Problem solving

Educación

Chemistry or Chemical Engineering degree

Herramientas

DeltaV

Electronic batch records

Descripción del empleo

We have an exciting opportunity for an Associate Director, Technical Operations – Drug Substance at our Elkton Site in Virginia, USA.At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

The successful candidate will provide technical leadership and operational support for the startup, technology transfer, validation, and ongoing commercial manufacture of active pharmaceutical ingredients (APIs).This role is responsible for leading technical activities across assigned processes and projects, supporting the capital project and facility startup phase through to commercialization and lifecycle management. The Associate Director will ensure safe, compliant, and reliable process performance, while driving continuous improvement and technical excellence.

Key Responsibilities

Technical Leadership Recognized subject matter expert in Drug Substance process support, and commercial manufacturingProvide technical oversight and hands‑on leadership for API manufacturing processes, including: Chemical synthesisPurificationCrystallization and drying operationsSupport the Capital Project Team, contributing to design, commissioning, qualification, and startup readinessLead process scale‑up, technology transfer, and validation (pre‑PPQ, PPQ) activities for assigned processesDrive improvements in process performance, yield, robustness, and impurity controlProvide technical guidance on:Process chemistryReaction performanceCritical process parameters and control strategiesAnalyze technical data and support decision‑making for process performance and improvementsIdentify and elevate risks, proposing practical, science‑based solutionsTechnology TransferLead and execute technology transfer activities for assigned processes across internal sites and external partnersSupport development and execution of tech transfer plans aligned with project timelinesProvide technical support for:Raw material evaluationProcess fit and manufacturabilityScale‑up readiness [Ensure accurate process documentation, knowledge transfer, and batch record readinessSupport process validation and continued process verificationOperational ExcellencePartner with Manufacturing to ensure safe, efficient, and reliable plant performanceProvide direct technical support to:Campaign preparation, execution, and follow‑upProcess troubleshooting during manufacturingLead and support deviation investigations, OOS, and CAPA, applying structured root‑cause analysisMonitor process performance and cycle times, identifying improvement opportunitiesDrive continuous improvement initiatives for yield, cycle time, and costSupport process optimization and debottlenecking activitiesRegulatory & ComplianceEnsure assigned processes operate in compliance with cGMP and regulatory expectationsSupport inspection readiness and audit activitiesContribute to regulatory submissions and responses, including data generation and technical inputEnsure data integrity and adherence to quality and safety standardsMaintain compliance from startup through commercial operationsCross‑functional LeadershipCollaborate with Engineering, Capital Projects, R&D, Quality, Supply Chain, and ManufacturingAct as a technical representative for assigned processes within cross‑functional teamsSupport technology transfer and process improvements across the networkParticipate in interactions with external partners and CMOs as requiredContribute to technical reviews and governance forumsPeople, Capability & Business LeadershipLead and develop a team of technical specialists and engineersProvide coaching, technical guidance, and performance feedbackSupport resource planning and execution of departmental prioritiesContribute to budget tracking and departmental administrationSupport recruitment, onboarding, and capability development initiatives

Qualifications

Degree (BSc/BEng/Masters) or higher in Chemistry, Chemical Engineering, or related disciplineSignificant experience (typically 10+ years) in:API process development and/or manufacturingStrong background in:Process chemistry and scale‑upProcess, equipment, and cleaning validationWorking knowledge of:cGMP manufacturing operationsRegulatory expectations and inspection readinessExperience with:Deviation management and investigationsElectronic batch records and process systems (e.g., DeltaV)Exposure to capital projects, CQV, and facility startupStrong analytical, problem‑solving, and communication skillsAbility to work effectively across cross-functional teams and multiple priorities

Our Culture

We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world’s most challenging healthcare needs. We believe breakthrough innovation happens when experienced leaders empower talented teams in an inclusive environment.

So, if you are ready to:

• Support delivery of new Drug Substance manufacturing capability
• Drive operational and technical excellence in API production
• Develop your leadership capability in a high-impact environment