Process Development/ MSAT Scientist
WhiteCap Search · Cambridge, MA · Yesterday
On-siteResearchContract
A biopharmaceutical organization is looking to connect with experienced Process Development and Manufacturing Science & Technology (MSAT) professionals with experience supporting the development and manufacturing of advanced therapies. This is a hands-on technical role supporting process development, technology transfer, manufacturing support, and ongoing process improvement. The position will work closely with cross-functional teams spanning Process Development, Manufacturing, Quality, Regulatory, and external manufacturing partners. ResponsibilitiesProvide MSAT and technical support across process development and manufacturing activities.Lead or support manufacturing investigations, change management, and technical assessments.Identify opportunities to improve manufacturing processes and support implementation of process improvements.Support technology transfer and process implementation from development into manufacturing.Coordinate technical activities across multiple functions, projects, and stakeholders.Establish project milestones, track deliverables, and communicate technical risks and potential solutions.Support process validation and process performance activities.Contribute to process monitoring, troubleshooting, and ongoing process improvement.Support process lifecycle management and maintain strong process knowledge throughout development and manufacturing.Prepare and review technical documentation supporting regulatory and manufacturing activities.Work with external manufacturing partners to provide technical guidance, resolve issues, and support successful execution of technical activities.Apply risk-based approaches to process development and manufacturing challenges.Collaborate with scientists, engineers, manufacturing professionals, quality representatives, and other technical stakeholders.Support multiple projects and priorities while maintaining strong attention to detail and execution.QualificationsPhD in Life Sciences, Chemical Engineering, or a related discipline, or a Master's degree with relevant industry experience, or a Bachelor's degree with significant relevant industry experience.Experience in MSAT, Process Development, Technical Operations, Process Engineering, or a closely related function.Hands-on experience supporting manufacturing investigations and change management.Experience with cell therapy, cell processing, or advanced therapy manufacturing strongly preferred.Understanding of cGMP/cGxP requirements within a regulated biopharmaceutical environment.Experience with technology transfer and implementation of processes into manufacturing.Experience supporting process improvement, process characterization, or lifecycle management activities.Familiarity with risk assessment and mitigation methodologies.Regulatory submission or technical writing experience is a plus.Experience working with external manufacturing partners or CDMOs is a plus.Strong project management, organizational, and communication skills.Ability to independently manage multiple projects and competing priorities.Strong interpersonal skills and the ability to work effectively across technical and non-technical teams.Location: Boston, MA Ideal Background This opportunity is particularly relevant for professionals with experience in MSAT, process development, technology transfer, cell therapy manufacturing, process engineering, manufacturing support, or process lifecycle management within a regulated biopharmaceutical environment. Candidates with adjacent experience in advanced therapies or complex biologics are also encouraged to connect. Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.