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Considered the founder of the industry, our client has been delivering on the promise of biotechnology for over 40 years. Our client is considered the leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.
Responsible for providing scientific and technical support to the Tech transfer team. Participate in cross functional meetings and provide update for the assigned tasks.
Deliverables include but are not limited to providing support for the MSAT in managing Quality Records in the QA system, authoring commissioning and Process Validation protocols.
● Assist MSAT personnel in the lifecycle of execution level process data and specifications.
● Performs work with limited direction and will start to be responsible for ongoing activities to ensure the groups goals are delivered properly and efficiently. Looked to as a leader and should be championing PE projects and initiatives. Performance will be measured on a both short term and long term perspective.
● Support implementation of manufacturing continuous improvement initiatives and support
of New Product Introduction (NPI).
● Provide technical support for all associated Make-Assess-Release activities related to
MSAT Quality records.
● Will finalize and standardize the CR strategy and requirements for current and future tech transfers and new product introduction by liaising with site and global expert
● Support risk analysis activities aimed at providing the most compliant and robust execution
of production at a unit operation level.
● Assist in the development and execution of projects and initiatives, both site and external,
with a focus on requirements/specifications development and management, Quality Change management and compliance.
● Act as Quality Change Control SME for management of regulatory level impact changes.
● Enable MSAT SME’s by supporting their efforts which may include including monitoring,
Trouble-shooting, corrective action and assessment and remediation of discrepant incidents
impacting manufacturing materials, methods and equipment.
● Will work with GMP Services and Quality to determine an optimized process for GMP Readiness and New Product Introduction.
● Contribute to regulatory filings.
● Proven knowledge and practical experience with core regulatory requirements
● Demonstrated working knowledge of process control, manufacturing execution and
● enterprise resource planning systems.
● Proven management, communication, interpersonal, organizational and project
● management skills.
● Demonstrated ability to work as part of a multidisciplinary team.
● Demonstrated proficiency in the application of basic manufacturing, engineering, and/or
● scientific theories, principles, and techniques used in biopharmaceutical manufacturing
● Ability to interact within and across work groups and with outside collaborators and vendors
● on technical matters.
● Demonstrated technical proficiency, leadership, creativity, and strategic thinking.
● Practical and theoretical expertise in biopharmaceutical manufacturing processes
engineering and applied technologies.
● Strong oral and written communication skills.
Education and Experience
● Bachelor's or Master's degree in Engineering or Life Sciences.
● 4-6 years experience in relevant field.
Work Environment/Physical Demands/Safety Considerations
Note: State work setting (manufacturing or office) and aspects of work that affect incumbents physically. If job requires lifting, ensure that maximum limit established by Safety department is not exceeded.
▪ Work in office and laboratory environment.
▪ May be on feet for 8 to 10 hours a day.
▪ Lift up to 25lbs may be required.
▪ May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.
▪ When working in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
▪ May work with hazardous materials and chemicals.
▪ Ability to sit, stand and move within work space for extended periods
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