Overview Principal Scientist, Manufacturing Technology (Process Transfer, Validation and Projects) at Bristol Myers Squibb. The role focuses on biologic drug substance commercial technical transfers, process validation, and project portfolio management at the Devens site. The position is a lead or critical support for commercial biologics technical transfers, engaging cross-functionally to ensure processes are designed and validated per cGMPs and regulatory guidance. Position Summary The Principal Scientist is a subject matter expert and process/project owner for biologic drug substance commercial technical transfers, process validations and project portfolio. The role drives process validation protocols, reports and exceptions, and contributes to CMC submissions. It will work with site support organizations to remove obstacles and ensure timely results. Key Responsibilities Responsible for the leadership and execution of biologics drug substance projects including commercial technology transfer, technical oversight of process design, process validation/re-validation, regulatory package authoring and successful inspection and approval for the Devens Biologics site. Influences technical direction for biologics drug substance manufacturing across media/buffer, cell banking, cell culture, purification, formulation and fill through to freeze. Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, and process control fundamentals in technical transfer and post approval process changes. Lead complex technical projects within biologics drug substance manufacturing and drive decisions that require developing new options to solve highly complex and/or novel problems. Responsible for supporting technical aspects of site regulatory inspections with understanding of regulatory environment and industry trends for biologics drug substance, including Pre-Approval Inspections (PAI) supporting technical transfer and post-approval process changes. Ensure timely delivery of assigned projects across technical transfer, process validation/qualification, and post-approval process changes at Devens Biologics. Routinely interact with the MS&T network for technical and operational improvements and issue resolution. Drive effective working relationships with Quality, Operations, Engineering, Global Regulatory Science, Technical Product Teams and others, internally and externally to the site. Qualifications & Experience Bachelor's degree or equivalent in a relevant engineering or scientific discipline with extensive experience; a minimum of 6 years required. A combination of education and experience may be acceptable. Technical execution experience in technology transfer and Process Performance Qualification. Experience with CMC filing activities preferred. Understanding of global regulatory requirements related to biologics drug substance processes. Solid knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, and process control in commercial manufacturing. Excellent communication and presentation skills with experience interfacing with multiple stakeholders and partner functions. Ability to work in a fast-paced, complex and changing environment. Strong analytical, technical, and strategic thinking skills; experience with project management systems/tools is preferred. Excellent organizational skills with ability to manage multiple technical projects. The starting compensation for this job in Devens, MA is in the range of $130,130 – $157,700 plus incentive cash and stock opportunities (based on eligibility). Final, individual compensation decided based on demonstrated experience. Eligibility for specific benefits varies by job and location. For more on benefits, visit Other benefits may include medical, dental, vision, 401(k), disability and life insurance, paid holidays, vacation, volunteer days, parental and caregiver leave, tuition reimbursement, and recognition programs. Benefit offerings are subject to plan terms and may change. On-site Protocol and Diversity Site-essential vs. hybrid vs. field-based occupancy is determined by role responsibilities. BMS provides equal employment opportunity and reasonable accommodations in the recruitment process. Applicants may request accommodations via adastaffingsupport@bms.com. See careers.bms.com/eeo-accessibility for the full EEO statement. BMS may require vaccination against Covid-19 and boosters to protect employees and communities. Location : Devens, MA #J-18808-Ljbffr Bristol Myers Squibb
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