Senior Scientist


Job description:

The Sr. Scientist will play a key leadership role in Drug Product Development and Operations (DPDO) to support process scale up and fill/finish process transfer from R&D to commercial manufacturing site for Teva innovative and biosimilar product pipeline. The incumbent will be the representative of DPDO group at the commercial manufacturing site located at Kfar Saba, Israel.

Key responsibilities:

Represent DPDO, as the person-in-plant, at Kfar Saba commercial manufacturing site to support Hand-in-Hand drug product technology transfer (TT) for phase III clinical batches, PPQ and commercial product manufacturing
Facilitate communication between DPDO and Kfar Saba technical groups to ensure effective collaborations during tech transfer
Partner with MS&T, manufacturing, engineering, and quality at the commercial site to support drug product process transfer
Assist the DPDO TT lead to obtain relevant information for input into the process risk assessment including but not limited to design and planning of process scale-up and process characterization studies
Participate in drug product development activities
Coordinate execution of scale-up and process characterization studies at Kfar Saba
Provide planning and logistics support for technology transfer and manufacturing execution
Conduct onsite Process Fit evaluation to identify technical gaps related to fill/finish equipment and manufacturing facilities
Provide onsite technical support during execution of manufacturing batches including review of manufacturing batch records prior and post batch execution
Author relevant R&D technical protocols, reports, and regulatory submission sections
Support translation of process requirements from source documents into protocols and batch records
Provide technical inputs for trouble shooting and investigations to close deviations
Attend and participate in DP technology transfer meetings including being responsible for completion of actions and bringing to the meeting relevant site information

Required qualifications:

Minimum requirements:

For the Sr. Scientist, Ph.D. with 3-5 years, Master degree with 6-10 years, or Bachelor’s degree with more than 10 years of related working experience
Experience in process technology transfer from R&D to commercial manufacturing site
Fluent in English and Hebrew, written and verbal
15% travel to Teva R&D at West Chester US

Preferred requirements:

Biologic DP process development and fill/finish experience including training on aseptic processing of sterile products
Understanding of CMC requirements for regulatory submissions such as INDs,BLAs and MAAs, with experience authoring relevant DP sections
Demonstrated ability to work in cross-functional teams across the business
Highly motivated individual, with ability to work in a team environment and build productive relationships between R&D and commercial manufacturing group
Strong organizational skills and attention to detail
Detail oriented with strong written and verbal communication skills
Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment

Job location

Kfar Saba, Israel