Principal Process Engineer, Sr Principal Process Engineer - South San Francisco, CA | Biospace
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Principal Process Engineer, Sr Principal Process Engineer

Theravance Biopharma US, Inc.

South San Francisco, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Masters Degree
Areas of Expertise Desired:
Engineering, Process, Process Engineer,

Job Description

Job Purpose

In this role, the primary responsibilities include management and execution of late phase activities related to the process development and manufacture of small molecule drug substances. This includes process optimization, robustness, safety, scale-up evaluations, and risk assessments. The person in this role will represent Process R&D on the CMC project teams and will be responsible for the drug substance manufacture to supply non-clinical and clinical studies, managing both internal kilo-lab and external CMO campaigns.

Duties and Responsibilities

•   Provides engineering expertise to process chemists and process engineers in the development and scale-up of API processes
•   Optimizes API processes to ensure safe and robust scale-up and provides supplies of intermediates and APIs
•   Plans and executes studies to characterize process design space and critical parameters for late stage programs
•   Manages CROs and CMOs effectively to achieve efficient and successful technology transfer and API manufacture
•   Manages and executes internal GMP production campaigns in a state-of-the-art kilo-lab facility
•   Prepares detailed technical and manufacturing reports to document the process development evolution and support technical transfer
•   Participates actively on CMC project teams to ensure timely and sufficient supplies for research, non-clinical, and clinical studies.
•   Authors and reviews content for CMC sections of regulatory submissions
•   Evaluates and implements new product technologies to ensure the most effective and efficient technologies are applied in process development and manufacture



Qualifications include:

•   MS/PhD Chemical Engineering or related field with at least 5 years of relevant experience
•   Proven track record in process development, manufacturing, and regulatory experience with late phase small molecule drug substances
•   Proven track record of working effectively on cross-functional development teams, and managing project plans and CRO/CMO activities
•   Experience and in-depth knowledge of cGMPs and regulatory requirements for API manufacture, including equipment qualification and operation
•   Experience with IND/NDA regulatory submissions and other regulatory interactions
•   Strong technical background and experience with laboratory process development, technical transfer, and plant scale production
•   Demonstrated ability to design experimentation and interpret complex data in the context of established scientific concepts
•   Strong project planning, written and verbal communication skills, and attention to detail

Direct Reports