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Sr. Director, Early Stage Bioprocess Development

Job Title: Sr. Director, Early Stage Bioprocess Development
Employer Name: Genentech, Inc.
Web Site: http://www.gene.com
Contact Name: Kevin Kannady
Contact Email: kannady@gene.com
Business Type: Industry
Job Type: Corporate Management
Job Country: US
Job Location: South San Francisco, California

Background:

Reporting to the Vice President of Process Development, the Sr. Director of Early Stage Bioprocess Development is charged with providing the necessary leadership, strategic vision, tactical execution and business acumen to support the commitment to being the world leader in cell line development, cell culture and purification bioprocess development.

The Sr. Director's responsibility will be to oversee development of efficient and reliable biochemical processes for multiple projects beginning with the support of discovery research, development of cell lines, definition of biochemical processes aimed at rapid generation of clinical supplies to support exploratory clinical studies, and clinical development through phase II. The successful candidate will also be a key champion of technologies interacting with Research, networking with the scientific community and translating and applying those advances into Early Stage Bioprocess Dev work.

Additionally, he/she will be a member of the Process Development senior leadership team and as such will be expected to work collaboratively as part of a team to establish priorities and direction for the organization to meet its business needs of delivering the pipeline, being innovative and efficient, as well, to achieve the company’s long range goals..

Duties:

1.Provide leadership and oversight to the Early Stage Biochem Development functions of Cell line development, Master Cell Bank cGMP manufacture, Early Stage Cell Culture and Early Stage Purification to support the commitment to being the world leader in cell culture and purification bioprocess development.

2.Build strong relationships and collaborate effectively with colleagues in the Research and Development organizations, and Product Operations/Regulatory Quality Compliance as appropriate:
•Research – late stage research activities in 3 therapeutic areas; New Technologies area
•Early Development – preclinical, Tox, Early Development Project Management
•Supply Chain Strategic Planning, and LRP process; clinical S&OP
•Manufacturing Collaborations
•Clinical Manufacturing
•Clinical Quality
•Regulatory

3.Play a key role in developing strategies and internal guidances via cross-functional teams on GMP continuum, Critical Path Initiative, Streamlining ES development, etc.
4.Serve as Business Process Owner (BPO) for Early Stage Process Development and be responsible for defining, developing and then managing the appropriate business processes or sub-processes needed therein including ensuring processes for close collaboration with PD NIMO group
5.Member of CMC Review Committee, and other appropriate review and governance committees.

Qualifications:

Ph.D in Life Sciences or Biochemical Engineering
•15+ years experience in bioprocess development, including 7 or more years of senior level management experience required
•Strong scientific understanding of Translational Research with good communication ability to serve as interface between Research and PD, and expertise in process development, tech transfer and/or bioprocess manufacturing required
•Demonstrated leadership success in both project and people management
• Demonstrated ability to drive for results and lead innovation and change
• Excellent leadership skills and the ability to motivate a team with dotted-line reporting relationship
•Ability to effectively communicate across all levels of the organization both internal and external to Genentech, Inc.
•Demonstrated success in business process/system development, influence management, collaboration and change management.
•Develops and oversees business plans that include attention to resources needed (e.g., budget, headcount) to accomplish goals. Demonstrates financial and business acumen
•Solicits and incorporates input on key business plans from major stakeholders to achieve alignment
•Proactively develops and mentors others to develop and retain key talent.