Development Associate II

Job Description About the role

As a Development Associate II, Technical Operations, you will work with other members of the Technical Operations group to lead tech transfers of products into the facility at bench and pilot scale and subsequently to commercial scale. You will be responsible for manufacturing technical support including batch records, deviations, change controls, investigations, life cycle management, scale down modelling, satellite runs, process validation, data tracking and trending, and supporting CMC regulatory filings.

• Will perform hands‑on laboratory support for the process operations and/or analytical methods.
• Plays a major role in preparation of technical reports and data summaries.
• Determine day‑to‑day priorities, with guidance of Supervisor.
• Perform laboratory activities to support Tech Ops projects following established procedures or developing procedures if needed.
• Maintains and operates lab equipment.
• Records and verifies laboratory data.
• Writes and maintains equipment working procedures.
• May assist in training other Development Associates.
• Draft studies and investigations of moderate scope and work on problems in which the analysis of the situation or data requires a review of identifiable factors.
• Work closely with senior level scientists to design and execute the proper studies.
• May serve as a lead author on reports that have limited scope.
• Maintain data integrity and perform data review activities.
• Responsible for maintaining laboratory supplies and reagents.
• May be involved in some direct manufacturing support as required.
• Complies with the safety guidelines while performing laboratory work.
• Develop a basic understanding of the drug development process.
• Develop an understanding of monoclonal antibody cell culture and downstream purification processes.
• Complete mandatory training within required timeframe.
• Perform other duties as assigned.

• Bachelor’s degree in a scientific discipline with 2+ years of relevant experience; or
• Master’s degree in a scientific discipline with 0‑3 years of relevant experience
• Previous experience in a regulated environment highly desirable.
• Must be capable of learning, understanding, and explaining scientific rationale behind downstream unit operations utilized in this role.
• Must have demonstrated knowledge of methodologies for analytical‑based positions; HPLC, ELISA, RT‑PCR, SDS‑PAGE, UPLC, spectroscopy, IEF.
• Must have demonstrated knowledge of the unit operations commonly used in monoclonal antibody manufacturing operations for upstream (cell culture) or downstream (purification) based positions: aseptic technique, experience propagating mammalian cells, bioreactor operation, column chromatography, ultrafiltration/diafiltration processes.
• Comfortable in operating laboratory equipment and associated software independently and training of junior level associates.
• Organized, team and detail‑oriented and able to work in a fast‑paced environment.
• Ability to make detailed observations, perform analysis of data and interpret results with minimal guidance.
• Ability to lead projects of limited and well‑defined scope.
• Maintains familiarity with relevant scientific literature.
• Self‑motivated, developmentally oriented individual.
• Ability to communicate effectively in verbal and written form.

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make‑up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• In general, the position requires a combination of sedentary work and walking /standing for periods of time in Manufacturing Sciences lab environment.
• May require occasional lifting up to 40 lbs.
• Willingness to travel to various meetings, trainings, or external sites;…