Essential Duties and Responsibilities include, but are not limited to, the following:
- Serves as a technical expert in all aspects of parenteral drug product manufacturing (including formulation, filling, visual inspection, labeling, packaging, etc.) to provide support for clinical and commercial products while ensuring safe, robust and high-quality production processes.
- Provide subject matter expertise (SME) to support project teams in technical transfers, process validations, technical due diligence, new product launches and capital projects. This may also include manufacturing site selection and capability assessments.
- Ensure rapid response to manufacturing events, proactively identify issues, determine root cause and implement effective CAPAs.
- Collaborate with local and global teams including Process Sciences, Manufacturing, Quality Assurance, Regulatory, etc. to support process development and successful technology transfer.
- Develop and implement a robust technical transfer methodology and process for all associated DP manufacturing from internal/external manufacturing partners.
- Lead, execute and improve the validation program, contamination control strategy, data integrity, etc. for equipment and manufacturing processes to ensure compliance with various Health Authority requirements.
- Ensure production is aligned with license requirements, cGMPs and global Health Authority expectations while representing a state of compliance during client, quality and regulatory audits/inspections.
- Own and continually improve technical support process with DP manufacturing operations that includes process and product monitoring, master data, documentation management and other operational readiness support activities.
- Provide regulatory filing support (IND, BLA, MAA, etc.).
- Develop and implement technology/automation best practices and standards across the network.
- Provide input and participate in long term strategic initiatives which enable sufficient growth to meet the emerging needs of our patients.
- Stay current with the trends and new emerging technologies as it relates to DP manufacturing to encourage innovation in manufacturing capabilities.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Demonstrated technical expertise in drug product manufacture and/or product development.
- Expert knowledge of clean room or classified area design/requirements.
- Deep process, equipment, automation, validation and technical knowledge that can support development/review of SOPs and applicable documentation.
- Expert knowledge in transferring aseptic parenteral filling and finish label/packaging operations with preferred experience in monoclonal antibodies and viral gene therapies.
- Significant experience in collaborating with internal/external partners.
- Working knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, Annex 1, etc.) across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).
- Strong project management, interpersonal, cross- cultural, communication, negotiation and problem-solving skills.
- Maintain a safe work environment and adhere to safety protocols.
- Demonstrate leadership and mentorship skills.
- Identify and solve engineering problems efficiently while managing multiple projects.
- Proficient in project management software and MS Office Suite.
- Six Sigma certification preferred.
- Ability to travel up to 25% (domestic and international).
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Engage in prolonged periods of sitting, standing, walking, bending, stooping, and stretching.
- Utilize hand-eye coordination and manual dexterity to operate portable tools, test instruments, computer keyboard, telephone, calculator, and other office equipment.
- Regularly lift and move objects weighing up to 50 pounds.
- Climb ladders and stairs of varying heights.
- Work under conditions that may be wet or humid.
- Provide support during off shifts, weekends, and holidays as needed.
- Work in outdoor weather conditions and noisy environments.
- Offer 24/7 support for company activities.
- Maintain mandatory attendance.
Minimum Qualifications:
- Masters of Science degree in engineering/technical field with 10 years of qualified experience in a similar role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency; OR
- Bachelor’s degree in engineering/technical field with 12 years of qualified experience in a similar role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency
- A minimum of five (5) or more years of previous leadership experience.
Preferred Qualifications:
- Knowledge of bio-processing filling equipment, clean utilities, and single use technology
- Knowledge of quality management software
- Knowledge of component suppliers, procurement and auditing
- Engineering/technical degree preferably in Mechanical, Chemical or Biomedical areas.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.