General Description:
+ The Senior Manager, Analytical Manufacturing Science and Technology (MST), provides technical leadership and project management for analytical method transfers to Hopewell QC laboratories. The role is also accountable for overseeing the MST Analytical Laboratory and its personnel, and instruments.
Essential Functions of the Job:
+ Provide strategic and technical oversight for MST Analytical Laboratory capabilities supporting monoclonal and bispecific antibody drug substance and drug product manufacturing.
+ Lead analytical method transfers of physicochemical, potency, and structural characterization methods to Hopewell Quality Control laboratories, including gap assessments, transfer strategy, protocol execution, acceptance criteria, and final reports.
+ Support analytical readiness for new product introductions and lifecycle projects by defining deliverables, risks, resources, dependencies, and completion criteria aligned with approved project timelines.
+ Perform or direct laboratory testing, as needed, using technologies including high-performance and ultra-high-performance liquid chromatography (HPLC/UHPLC) and capillary electrophoresis (CE).
+ Provide scientific leadership for method qualification and validation, analytical comparability, method performance trending, and complex OOS, OOT, and investigations.
+ Author, review, and approve GMP documentation, including analytical transfer plans, protocols, reports, study plans, deviations, corrective and preventive actions, change controls, and standard operating procedures.
+ Support analytical content for global regulatory submissions, supplements, health authority responses, commitments, and inspection-readiness activities.
+ Establish metrics and governance for transfer progress, laboratory readiness, method performance, investigation closure, and on-time delivery; escalate risks and implement mitigation plans.
Supervisory Responsibilities:
+ Manage and develop direct report(s), including workforce planning, hiring, onboarding, objective setting, coaching, performance management, succession planning, and technical capability development.
+ Build an analytical team capable of supporting technology transfer, process development and small scale studies.
+ Lead cross-functional collaboration with Manufacturing Operations, Quality Assurance, Quality Control, CMC, Regulatory Affairs, Process Development, and external partners.
Computer Skills:
+ Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
+ Statistical software application experience preferred (JMP, minitab, etc)
+ Experience with LIMS (Laboratory Information Management System ) preferred.
Education:
+ Bachelor’s degree in analytical chemistry, biochemistry, pharmaceutical sciences, or a related scientific discipline with 7+ years of relevant biopharmaceutical experience required.
+ Master’s degree in a related discipline with 5+ years of relevant biopharmaceutical experience preferred.
Other Qualifications:
+ Required: Demonstrated expertise in biologics analytical methods and protein product quality attributes; analytical method transfer.
+ 5 years of direct people-management or substantial leadership of analytical teams, projects, or programs.
+ Preferred: Experience with regulatory submissions, laboratory start-up or capability expansion.
Travel: Up to 10%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.