Responsibilities
- Lead the design, implementation, and ongoing management of manufacturing processes for non-sterile solid oral dosage forms, including both hazardous and non-hazardous compounds in tablet and capsule formats.
- Define and oversee unit operations such as weighing, dispensing, powder transfer, blending, sifting, compression, encapsulation, dedusting, and packaging, prioritizing process robustness, repeatability, quality assurance, and operator safety.
- Act as the primary process owner after technology transfer, ensuring process intent is preserved and consistently executed during routine compounding operations.
- Identify, monitor, and manage Critical Process Parameters and Critical Quality Attributes using risk assessment tools like FMEA.
- Set, refine, and document equipment operating parameters and control strategies following initial transfer from R&D.
- Evaluate process performance data—including blend uniformity, weight variation, tablet hardness, and capsule fill weight—to assess operations, investigate deviations, and support improvement initiatives.
- Apply Lean manufacturing and continuous improvement methodologies to increase throughput, minimize waste, and improve process consistency.
- Develop and maintain User Requirement Specifications for solid dose manufacturing and material handling systems.
- Create, review, and interpret P&IDs, Functional Design Specifications, and Sequences of Operation to clearly define process and equipment needs.
- Support equipment selection, vendor interactions, and technical evaluations to ensure alignment with process requirements, containment, cleanability, and regulatory standards.
- Participate in Factory Acceptance Tests, Site Acceptance Tests, commissioning, and startup for new or modified equipment.
- Collaborate with Quality and Validation teams to support Installation, Operational, and Performance Qualification of solid dose equipment and systems.
- Establish calibration requirements relevant to process performance and ensure equipment remains suitable for its intended use.
- Support cleaning validation efforts and verify that equipment design and operation enable effective, repeatable cleaning.
- Contribute to facility and room layout planning, including material and personnel flow, pressure differentials, and containment strategies for hazardous and non-hazardous operations.
- Ensure manufacturing processes comply with applicable USP chapters such as <795> and <800>, along with cGMP standards.
- Write and maintain SOPs, batch record content, risk assessments, and change control documentation related to solid dose processes.
- Support investigations into deviations, CAPAs, and data integrity issues associated with solid dose manufacturing.
- Maintain documentation systems in a state of audit readiness and provide technical support during internal audits and regulatory inspections.
- Support the transfer of processes from R&D to compounding, ensuring formulation sensitivities, risks, and controls are clearly communicated.
- Convert development and scale-up data into reliable, scalable manufacturing processes suitable for routine production.
- Work cross-functionally with Pharmacy, Manufacturing, Quality, Validation, Engineering, and EHS teams to ensure successful process implementation and operation.
- Provide direct technical support to resolve process deviations, equipment malfunctions, yield issues, and material flow problems.
- Lead and engage in structured problem-solving activities to enhance safety, quality, efficiency, and regulatory compliance.
- Drive continuous improvement projects to strengthen process capability and long-term operational reliability.
Other
- Willingness to travel as needed for vendor-related activities and facility support.
- The company is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during the job application process.
- All qualified applicants are considered for employment without regard to arrest or conviction history, in compliance with the San Francisco Fair Chance Ordinance, Los Angeles County Fair Chance Ordinance, California Fair Chance Act, and similar local or state laws.
- In Massachusetts, it is illegal for employers to require or administer lie detector tests as a condition of employment; violations may result in criminal and civil penalties.
