Reporting to QC Technical Support Manager, the QCTS Associate Scientist will lead and support the method validation, transfer, troubleshooting and technical documentation for cGMP biologics commercial and clinical manufacturing analytical laboratories. This role will act as a Subject Matter Expert (SME) for bioanalytical methods such as cell based bioassays, ELISA, PCR assays, and provide technical support to QC Operations.
Major Responsibilities include:
Participate in multi-site method transfer and validation projects for Devens QC: Author and review validation, transfer protocols and reports; execute validation and transfer independently; summarize, review and approve data; troubleshoot the failures and deviations and make recommendation on corrective actions.
Provide support to QC Operation as method SME: develop training approach, training documents and provide training for new methods; support QC method troubleshooting, lab investigations, OOSs, OOTs, CAPAs, Data Integrity initiatives; Assist in method performance review, able to recognize anomalous trends or results and make recommendation on method life cycle management and improvement; work closely with Analytical Science and Technology on developing and implementing innovative techniques into QC Operations.
Provide support to QC department on equipment: serve as instrument SME related to Bioassay and ELISA assays; work with instrument qualification team to assist in equipment IOPQs and troubleshooting with internal teams and external vendors; support new versions of software implementation including method impact assessment, validations and comparability studies.
Support health authority inspections such as FDA, EMA, and other health agencies.
BS / MS, preferably in Analytical Chemistry, Bioanalytical or Biology field. Minimum of4 years (MS) /6 years (BS) relevant experience in Biologics or biopharmaceutical cGLP or cGMP lab. Knowledge in cGMP regulations as referenced in The Code of Federal Regulations. Strong background and demonstrated effectiveness with method validation transfer for biologics methodology.
Strong problem solving ability, interpersonal, oral and written communication skills.
Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
Contribute to a team based, collaborative, and positive environment, with clarity of purpose and a high commitment to business goals.
Familiar with data analysis software such as PLA, SAS, Softmax and QC laboratory systems such as electronic notebooks (ELN) and LIMS is desirable.