Development Associate II

Role Summary

Development Associate II, Technical Operations, will work with the Technical Operations group to lead tech transfers of products from bench and pilot scale to commercial scale. Responsible for manufacturing technical support including batch records, deviations, change controls, investigations, lifecycle management, scale-down modelling, satellite runs, process validation, data tracking and trending, and supporting regulatory filings.

Responsibilities

• Perform hands-on laboratory support for process operations and/or analytical methods.
• Prepare technical reports and data summaries.
• Determine day-to-day priorities with guidance from the Supervisor.
• Conduct laboratory activities to support Tech Ops projects, following established procedures or developing procedures as needed.
• Maintain and operate lab equipment; record and verify laboratory data.
• Write and maintain equipment working procedures.
• Assist in training other Development Associates.
• Draft moderate-scope studies and investigations; analyze data to review identifiable factors.
• Collaborate with senior scientists to design and execute studies; may lead reports with limited scope.
• Maintain data integrity and perform data review; manage laboratory supplies and reagents.
• Contribute to direct manufacturing support as required; follow safety guidelines.
• Develop understanding of the drug development process and monoclonal antibody cell culture and downstream purification processes.
• Complete mandatory training within required timeframe; perform other duties as assigned.

Qualifications

• Required: Bachelor’s degree in a scientific discipline with 2+ years of relevant experience; or Master’s degree with 0-3 years of relevant experience.
• Required: Demonstrated knowledge of methodologies for analytical-based positions (HPLC, ELISA, RT-PCR, SDS-PAGE, UPLC, spectroscopy, IEF).
• Required: Knowledge of unit operations in monoclonal antibody manufacturing (upstream/downstream), aseptic technique, mammalian cell propagation, bioreactor operation, column chromatography, ultrafiltration/diafiltration.
• Required: Ability to learn, understand, and explain scientific rationale behind downstream unit operations; capability to operate lab equipment and associated software independently; training of junior associates.
• Required: Organized, detail-oriented, able to work in a fast-paced environment; effective verbal and written communication.
• Preferred: Previous experience in a regulated environment.
• Preferred: Familiarity with current scientific literature; ability to lead projects of limited scope; self-motivation and development orientation.

Education

• Bachelor’s degree in a scientific discipline ( required )
• Master’s degree in a scientific discipline ( preferred )

Skills

• Analytical techniques: HPLC, ELISA, RT-PCR, SDS-PAGE, UPLC, spectroscopy, IEF
• Monoclonal antibody cell culture and downstream purification operations
• Lab equipment operation and software proficiency
• Data integrity, data review, and technical reporting
• Training and mentorship of junior staff

Additional Requirements

• Work in controlled manufacturing environments with gowning and PPE; potential cold, wet environment.
• May require travel (~5%) and occasional lifting up to 40 lbs; may work multiple shifts including weekends.