Senior Manager, Biologics Process CMC; External

Position: Senior Manager, Biologics Process CMC (External)
Senior Manager, Biologics Process page is loaded## Senior Manager, Biologics Process locations:
Alameda, CAtime type:
Full time posted on:
Posted 2 Days Agojob requisition :
JR6388
** SUMMARY/

JOB PURPOSE:

** The Senior Manager provides technical leadership and support across multiple CMC biologics areas to drive late-stage process development, technology transfer, Process characterization, Process Validation and manufacturing of biological drug candidates with a focus on Biologics including mAbs, Bi-specifics and Antibody Drug Conjugates (ADCs).  The Senior Manager utilizes their technical expertise in biologics process and / or bioconjugation process chemistry and process engineering to advance CMC development and manufacturing for in-clinic biologics and bioconjugate molecules.  

A strong technical focus is critical to ensure the speed, cost effectiveness and technical quality of our CMC activities.  The individual works independently and in cross-functional teams, leads and drives selected technical initiatives and CMC projects, and works effectively with internal and third-party CDMO partners. The individual has familiarity with analytics and formulation as they are working closely with these groups in addition to a general working knowledge of Biologics CMC.
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* ESSENTIAL DUTIES AND RESPONSIBILITIES:

*** Apply technical knowledge and expertise in biologics process and / or bioconjugation, late-stage process development and technology transfer, process characterization and process validation to advance biological drug candidates across the product life cycle
* Support transfer, development and scale-up of biologics process and / or bioconjugation from early-stage CMC , into late-stage CMC to enable late stage clinical and commercial production
* Collaborate with internal and external partners in analytical and formulation groups to advance CMC biologics programs
* Deliver technical support to ensure successful clinical manufacturing, and to develop and implement process improvements as programs advance
* Lead and support various elements of late-stage CMC development activities, such as risk assessments, process characterization, control strategy, and process validation
* Analyze, interpret, present and document complex technical information such as development data or manufacturing and testing trends, in support of CMC objectives
* Work with contract development manufacturing organizations (CDMOs) to help define project scope, review proposals, and oversee technical work
* Contribute to CMC regulatory strategies and submissions, and quality documentation
* Contribute to a broad range of technical objectives, such as troubleshooting urgent issues, proactive monitoring, and analysis of ongoing manufacturing/testing, and longer-term development efforts.
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* SUPERVISORY RESPONSIBILITIES:

*** Supervises, hires, trains, provides work direction, and problem-solving assistance for less experienced scientists. May directly oversee the daily operations of other staff
* May provide scientific direction to CDMO project teams to enable project progression
** EDUCATION/EXPERIENCE/KNOWLEDGE &

SKILLS:

**** Education/

Experience:

*** Bachelor’s degree in chemistry, biochemistry, chemical engineering or related field and a minimum of nine years of relevant drug discovery/development experience; or,
* Master’s degree in chemistry, biochemistry, chemical engineering or related field and a minimum of seven years of relevant drug discovery/development experience; or,
* Ph.D. in chemistry, biochemistry, chemical engineering or related field and a minimum of two years of relevant drug discovery/development experience after completion of post-doctoral training; or,
* Equivalent combination of education and experience.
** Experience/The Ideal for Successful Entry into Job:
*** Experience applying their technical knowledge to drive critical objectives for CMC biologics across the product life cycle
* Experience in late-stage bioprocess and / or bioconjugate process chemistry/purification with a working knowledge of CMC process development, technology transfer, and GMP quality requirements
* Demonstrated capability to work independently on…