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Sr. Director, Late Stage Bioprocess Development

Job Title: Sr. Director, Late 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 Late Stage Bioprocess Development is charged with providing the necessary leadership, strategic vision, tactical execution and business acumen to support the key business needs of the organization.
The Senior Director's responsibility will be to lead an organization of ~150 employees focused on the development of scaleable and robust bulk manufacturing processes for Phase III clinical and commercial manufacturing of recombinant therapeutic proteins. Key activities include process optimization and scale-up, process characterization and validation, technology transfer, preparing regulatory documents, as well as process improvements and technical support of commercial products being produced at GNE plants and at CMOs. The successful candidate will also be a key champion of new process and manufacturing technologies to ensure that Genentech will be a technology leader in the future and to support the Product Operation Organization’s vision of being the most admired biotech manufacturing organization.

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:

Key accountabilities and responsibilities include the following:
1.Provide leadership and oversight to the Late Stage biochem development functions of Late Stage Cell Culture, Late stage Purification, and Viral Validation 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 PROP/RQC:
a.Supply Chain Management
b.Manufacturing
c.MSAT
d.Manufacturing Collaborations
e.Corporate Engineering
f.Quality
g.Regulatory
3.Play a key role in developing strategies and internal guidances via cross-functional teams on Process Validation, Quality by Design, Regulatory approaches , Quality systems.
4.Develop appropriate processes and systems for transmitting process and equipment requirements to Corporate Engineering
5.Serve as key PD contact to the Product Ops. Class A initiative (Summit); also serve as Business Process Owner(BPO)for Late Stage Process Development and be responsible for defining, developing and then managing the appropriate business processes or sub-processes needed therein.
6.Member of CMC Review Committee, and other appropriate review and governance committees.

Qualifications:

•Ph.D in Engineering or Life Sciences
•15+ years experience in bioprocess development, including 7 or more years of senior level management experience required
•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.