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Senior Manager of Aseptic Manufacturing
2 months ago
Contract: 1 year assignment
Job ID: 68439
Location: Fully Remote (ideal candidate within reasonable travel distance to manufacturing site)
Pay Rate: Up to $39/hr. W2
This position is for a Subject Matter Expert (SME) in aseptic drug product manufacturing. The successful candidate will spearhead the coordination of activities to transition the drug product fill-finish process to the manufacturing facility. This encompasses compounding, filling, and optical inspection.
The incumbent will lead intricate Technology Transfers and Process Performance Qualification (process validation) initiatives that enhance the reliability and sustainability of our products at external manufacturers.
Key Responsibilities:
- Independently drive and execute complex projects requiring thorough analysis of various factors across multifunctional areas.
- Effectively communicate with core team members.
- Influence cross-functional teams and lead initiatives to achieve collective goals.
- Travel to manufacturing sites as necessary to provide on-site support, particularly during qualification batch production.
The ideal candidate should possess expertise in biologic drug product manufacturing processes. Experience in Quality, R&D, and Manufacturing Operations is highly desirable. Knowledge of process validation for pharmaceutical ingredients or products is a plus. Domestic travel to manufacturing sites may be required, up to 25%.
Primary Tasks:
- Lead complex technology transfers focusing on risk management and right-first-time execution.
- Act as an SME to identify areas for technical and supply chain improvements.
- Oversee drug product Process Performance Qualification and the preparation of regulatory documentation.
- Support internal and external teams to ensure manufacturing site readiness and sustainability.
- Provide SME input on complex investigations and corrective actions as needed.
- Represent the company in interactions with external manufacturing partners.
- Manage international sample shipments and support investigations as a technical expert in drug product manufacturing.
- Review and approve batch records, validation protocols, and related documentation.
Required Competencies:
- Proven experience in project leadership, pharmaceutical process development, new product introduction, technology transfer, and production support.
- Demonstrated technical competency in biologic drug products.
- Experience managing technology transfers and Life Cycle Management projects.
- Collaboration with R&D and supply chain groups to enhance product fit for commercialization.
Personal Attributes:
- Motivated self-starter with strong problem-solving skills.
- Innovative mindset focused on driving change and competitiveness.
- Ability to foster team productivity and cohesiveness.
- Strong prioritization and time management skills.
- Capability to navigate complexity and change effectively.
Educational Background:
- Engineer or Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with a minimum of 4 years of experience in biopharmaceuticals, or a Bachelor's degree with 8 years of experience.
Language Proficiency:
- Fluent in written and spoken English.
Physical Requirements:
- Ability to work in an international environment across different time zones.
Travel Requirements:
- Approximately 25% of time based on role and specific business objectives.
