What You’ll Do
• Provides oversight and supports the team with the introduction of new raw materials, and associated document requirements
• Ensures regulatory compliance, assesses vendor change notifications, and provides strategic input on raw materials related matters
• Oversees and supports change requests for introduction, modification, and discontinuation of raw materials
• Acts as a scientific liaison between Quality Control (QC), Supply Chain, Manufacturing, and Quality to assess material and supplier risks (e.g., supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions)
• Develops and implements training for manufacturing staff on process improvement initiatives, as needed
• Leads or coordinates troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations related to materials used in manufacturing, as needed
• Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects
• Supports process sub-teams throughout the phases of technology transfer (TT)
• Serves as SME to support TT stage gate reviews on incoming processes and manufacturing readiness (e.g., acceptable process material evaluations, risk assessments, mitigation, and robust supporting data for the proposed changes)
• Provides comprehensive written manufacturing reports summarizing investigations, studies and projects
• Supports generation of sampling plans for process validation reports (PVRs) and investigations
• As technical SME, leads and supports generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures or policies
• Collaborates with the Manufacturing department to support commercial and clinical manufacturing campaigns, investigate materials issues, and implement necessary changes
• Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, and global teams when applicable, to improve manufacturability, reliability, yield and cost
• Deploys and maintains Large Scale Business Unit (LSBU) strategic roadmap for continuous and breakthrough improvements, and associated requirements
• Provides solutions in selecting methods, evaluating, adapting of complex techniques to obtaining results consistent with departmental objectives
• Other duties, as assigned
Knowledge and Skills
• Builds connections with key contacts within the department and outside specialty
• Adjusts communication style to convey messages effectively within the team
• Provides guidance on routine matters pertaining to material science and supports the team in reaching business objectives
• Influence and cross-team collaboration. Engages in important conversations with cross-functional team members
• Simplifies complex ideas into understandable information for various audiences
• Develops basic hypotheses for projects
• Possesses fundamental project management skills. Effectively communicates information to others
• Thinks critically and self-directed with minimal oversight
• Understands basic project management and quality systems (e.g., Change Control, document management system)
• Strong communication and teamwork skills
• Solid grasp of material investigation methods Stays informed about regulatory and quality requirements in manufacturing
• Knowledgeable of material investigation principles and techniques
Basic Requirements
• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 5 years of relevant experience; OR
• Master’s degree in Engineering, Life Science or Chemical Engineering with 3 years of relevant experience; OR
• PhD with no prior experience
• Experience working in a Good Manufacturing Practices (GMP) environment
Preferred Requirements
• Prior drug substance or manufacturing experience, including expertise in process validation, transfer and commercialization, and manufacturing support and troubleshooting
• Experience supporting or writing portions of regulatory filings and supporting regulatory audits
• Direct experience with new product launches and validation of process
• Experience managing global or multi-site validation programs
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes
Ability to sit for prolonged periods of time. X No Yes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. X No Yes
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes