Sr. Manager Upstream Process Development

·        Lead the client projects starting from the development and optimization toward cGMP manufacturing for clinical trials, registration, or improvements of existing processes and products

·        Interact and collaborate with clients regarding the Upstream activities of the program including design and execution of the experiments, analysis, and presentation of the experimental results

·        Act as subject matter expert in Upstream Process Development of biologics including, but not limited to vaccines, viral vectors and recombinant proteins.

o   Provide expertise on both small and large scale process development activities including cell line development, optimization studies in shake flasks and 2-5L scale bioreactors as well as execution of 10-200L scale bioreactors

o   Extensive experience with single-use bioreactors and systems preferred

o   Lead the training and evaluation of product harvest and recovery strategies, based on product type and client requirements

·        Develop and execute large scale (50 – 200 liter) productions and harvest protocols utilizing technical knowledge to scale-up to manufacturing scales

·        Assist technology transfer group in drafting PFDs and reviews them. Provide technical support in engineering and GMPs runs

·        Lead and participate in decision-making processes within the project team by actively engaging in scientific and technical discussions

·        Expand the technical capabilities of Process Development group, by offering expertise in areas such as technology development, platform or systems development, or using a literature precedent

·        Manage and lead junior staff to ensure optimum utilization of resources on follows:

o   Planning daily, weekly, monthly schedules

o   Goal setting and performance reviews

o   Teaching others in their area of expertise, and assists with work being performed by other members of the Upstream Process Development group

·        Communicate with different departments to make sure the process is successfully transferred from PD to cGMP manufacturing

·        Plan, develop, organize, and implement policies, procedures and standards for lab operations to ensure the efficiency, optimal performance and quality control of the laboratory while maintaining company standards and compliance with federal, state and local regulations

·        Manage daily lab operations; support all lab scientists by managing and providing resources required to perform all aspects of their work

·        Coordinate the ordering, inventory, storage and maintenance of supplies, lab disposables and instruments essential to laboratory operations

·        Maintain a safe and compliant laboratory work environment: coordinate with the EHS manager to implement EHS initiatives; work with team leaders to facilitate compliance with EHS policies and procedures; and assist Facilities Engineering to ensure laboratory is maintained in compliance with regulatory codes

·        In coordination with the EHS Manager, oversee environmental health and safety program in the laboratory, assist safety professionals and licensing agencies and interface with building facility representatives for facilities-related matters

Requires a Bachelor’s degree in Biology, Biochemistry/Chemistry and 7 years of experience in job offered or 7 years of experience as a Associate Scientist or any other job title performing the following job duties:

·        Leading the client projects starting from the development and optimization toward cGMP manufacturing for clinical trials, registration, or improvements of existing processes and products

·        Aiding in design and execution of the experiments to develop and improve scalable protein production processes utilizing different expression systems with focus on mammalian and insect cell cultures;

·        Providing hands-on support to team executing experiments to generate material for production of the recombinant proteins, and viral vectors etc. from flasks to bioreactors;

·        Leading a team of scientists and engineers involved in process development, coach and mentor them to fulfill both group as well as individual performance goals.

·        Interacting with appropriate analytical and downstream functional areas to determine appropriate method for culture harvest and protein recovery;

·        Collecting, analyzing and interpreting the experimental data for reports and presentations;

·        Developing and executing large scale (50 – 200 liter) productions and harvest protocols utilizing technical knowledge to scale-up to manufacturing scales

·        Understanding and application of aseptic techniques;

·        Performing cell culture handling, cell growth characterization and optimization at different scale;

·        Producing material at different scale using various platforms from flasks to stirred-tanks and packed bed bioreactors;

·        Instrument care, maintenance, troubleshooting and data interpretation;

·        Writing standard operation procedures, protocols, process flow diagrams and batch records;

·        Participating in decision-making processes within the project team by actively engaging in scientific and technical discussions.

·        Interacting with clients reporting the data, discussing the results, presenting the design of the experiments and study plans. 

Salary Range: $133,786.00 to $160,000.00/year.  Please apply online at https://www.catalent.com  under Posting Number 0089367.