Associate Director of Manufacturing, Upstream

Asahi Kasei•Fremont, CA

About The Position

The Associate Director of Manufacturing, Upstream will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific West Warren site. As part of the Upstream/Manufacturing group, you will have opportunities to work on and take ownership of a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into the GMP manufacturing facility. The position performs professional planning, coordination, analysis and reporting of various project work according to Bionova Scientific guidelines and project management strategies. The role will frequently provide hands-on execution of complex experiments in a team setting. The position will train, supervise, and mentor technical staff. The role will lead GMP manufacturing activities.

Requirements

BS, or MS in Engineering, Life Sciences, or related discipline with 10+ years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
In-depth understanding of Cell Culture and industry-standard cell culture processes (scale up, Bioreactor parameters and operations, depth filtration, media and solution prep, etc) and equipment (Cytiva XDR, SUB)
Hands-on experience in running, developing, and validating processes.
Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
Experience with process monitoring software and equipment software
Creative thinker that can identify better and more efficient methods to address issues and gaps and then create processes to enable efficient execution.
Demonstrate ability to work independently and on cross-functional teams.
Strong analytical skills and attention to detail.
Effective verbal and written communication skills.
Ability to prioritize assignments and to manage multiple projects simultaneously.
Capable of independent and rapid decision making based on data, scientific knowledge, and sound judgement
Must have the ability to work efficiently in a fast-paced environment.
Flexibility with work hours to meet business needs, including weekends and holidays, as needed.
Management experience is required

Responsibilities

Executes and supervise complex unit operations including but not limited to Bioreactor operations, depth filtration, media prep, buffer prep.
Maintains own training within compliance and trains other associates on cell culture operations in GMP environment upon completion of trainer qualification.
Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP upstream manufacturing activities.
Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
Documents work according to cGMP and cGDP.
Adheres to established regulations and follows cGMP established by site.
Maintain cleanroom standards, practices, and housekeeping according to SOPs.
Recognize any issues from the equipment and any affiliated documentation and take appropriate corrective action within scope.
Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
Evaluate new technologies and innovations to improve operational efficiency or expand purification capabilities
Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.
Present during inspections from regulatory agencies and client audits