Specialist, Manufacturing

Manufacturing Specialist

• This role is responsible for providing technical oversight and direct support to manufacturing operations. In addition, supports troubleshooting equipment-related issues and develops process solutions to address identified problems. Acts as Manufacturing lead for tech transfer activities. Reports to a Manufacturing Manager.

About the role:

• Provides technical support for the manufacture of a gene therapy product. Supports troubleshooting equipment-related issues and develops process solutions to address identified problems.
• Writes/revises standard operating procedures (SOPs), training documents (OJTs) and batch records (BPRs).
• Acts as system owner to support equipment qualification / re-qualification
• Leads deviation investigations to adequately identify the root cause and implements appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence. Employs standardized root cause analysis, investigational tool, and methodologies. – Take on Majors only moving forward
• Identifies and implements continuous improvement projects to improve yield, reliability, and/or process robustness.
• Writes and implements change controls for the manufacturing area.
• Participate in tech transfer of new products into the facility.
• Provides training and technical development for the manufacturing team.
• Responsible for coordinating activities to support manufacturing (i.e. raw materials and BPR issuance) as needed.
• Ensures manufacturing goals are achieved through robust safety practices and quality compliance.
• Develops and maintains departmental metrics and key performance indicators (KPIs).
• Work closely with Manufacturing and Quality to continually improve all aspects of operations.
• Provide on-the-floor support during manufacturing operations.

Requirements:

• Bachelor's degree with 5 years of progressive experience in roles involving cGMP biologics, cell therapy, and or gene therapy manufacturing
• Expertise in relevant Manufacturing production activities
• Proven ability to effectively plan and coordinate activities based on capacity, priorities, and commitments
• Prior experience in quality investigations and deviation writing in a manufacturing environment is highly desirable.
• Effectively lead and facilitate functional and cross-functional teams

About You:

• Thrive working in a highly matrixed, fast-paced, cross-functional team environment
• Capable of influencing without authority, exercising cultural sensitivity, and effectively communicating in a variety of settings
• Ability to prioritize, balance work from multiple individuals, and provide clarity and focus
• Adept in transforming preliminary or ambiguous information, ideas, or problems into well-defined plans and solutions
• Capable of distilling complex business issues into simple problem statements to quickly grasp the scope of the issues, recommend solutions, and drive for resolutions
• Ability to be flexible and adjust plans rapidly to meet changing business needs
• Independently motivated, detail oriented, with strong problem-solving knowledge and capabilities
• Ready and excited to embrace the Resilience phenotype!