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General Description:

Reporting directly to the Director of Manufacturing Sciences & Technology (Purification), this position is pivotal within the MST Purification team. Responsibilities include technology transfer, campaign readiness, process qualification, monitoring, deviation/CAPA management, process improvement projects, and Continued Process Verification (CPV). The role requires expertise in unit operations such as chromatography, tangential flow, depth, viral and dead-end filtration, buffer preparation, and product quality analysis. Key duties involve leading data analysis, authoring protocols and reports, and designing experiments to support parameter classification and control ranges. The position also supports compliance-related activities and provides technical support to manufacturing.

Key Responsibilities:

+ Lead data analysis and author various protocols and reports.

+ Design experiments to support parameter classification and control ranges.

+ Support compliance-related activities and provide technical support to manufacturing.

+ Author department standard operating procedures and ensure training of junior staff.

+ Support regulatory filings by authoring required sections, responding to regulatory authority questions, and participating in inspections.

+ Collaborate closely with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, and Process Development groups.

Essential Job Functions:

+ Participate in cross-functional project teams supporting manufacturing and process development.

+ Ensure a safe working environment.

+ Author study protocols, reports, and documentation supporting deviations and regulatory activities.

+ Perform technology transfer activities, including facility gap and risk assessments.

+ Provide technical support as a SME for purification process implementation.

+ Author technical transfer plans, process descriptions, control strategies, and campaign summary reports.

+ Author process validation plans, PPQ protocols, and downstream study protocols to support PPQ.

+ Perform CPV and process monitoring during campaigns.

+ Communicate effectively with team members and stakeholders.

+ Serve as Person-In-Plant (PIP) during critical manufacturing steps.

+ Perform manufacturing data analysis.

+ Support on-site supervision and management of contract employees or third parties as required.

Qualifications:

+ Minimum of 5 years in Life Science/Biotechnology with a BS, or 4 years with an MS.

+ Demonstrated experience in a cGMP manufacturing environment and purification laboratory.

+ Knowledge of drug preclinical, clinical, and commercial requirements.

+ Familiarity with EMA and FDA regulatory requirements for submissions.

+ Effective communication skills, both oral and written, in a multi-disciplinary, project-driven environment.

+ Proficiency with software such as Microsoft Office and SAP.

+ Expertise in Mab Facilities and Process Design/Development.

+ Proficiency with large-scale downstream equipment (e.g., chromatography systems, tangential flow filtration, filtration, and analytical equipment).

+ Experience with commercialization of large molecules and/or Mabs, including downstream process design, optimization, and tech transfer to clinical/commercial manufacturing facilities.

+ Expertise in manufacturing data acquisition, process monitoring, and process historian (PI).

+ Knowledge of FDA, EMA, ICH regulations and guidelines, and experience with regulatory inspections.

+ Experience responding to regulatory requests for information.

+ Subject matter expert in process statistical methods, process capability assessments (Cpk), and out-of-trend procedures.

+ Strong analytical skills, including data analysis, detecting inconsistencies, and utilizing risk analysis tools.

+ Expertise in study design (DOE) and authoring study protocols/reports.

+ In-depth knowledge of GMP requirements.

+ Proven planning and data analysis skills, including the use of statistical software.

+ Project management skills for internal and external teams.

Physical Requirements:

+ Ability to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.

+ Ability to work scheduled 40 hours with the flexibility to work overtime as needed.

+ Comfort working in varying temperatures.

+ Ability to gown and work in manufacturing areas when required.

+ Some reaching, bending, stooping, and twisting.

+ Repetitive motion and substantial movement of the wrists, hands, and/or fingers.

+ Environment requires dedicated gowns, depending on the area.

+ Work with hazardous materials and chemicals.

+ Willingness to work off-shift when required.

Supervisory Responsibilities:

+ None

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.