REG'D CITY CLERK
2024 JUL 3 P4:05:35
The City of South San Francisco
Office of the City Clerk
400 Grand Avenue
South San Francisco, CA 94080
CALIFORNIS (650) 877-8518
BOARDS AND COMMISSIONS APPLICATION
APPLYING FOR (more than one may be selected)
Bicycle and Pedestrian Advisory Committee*
*Must be a resident offor employed in South San Francisco Conference Center Authority -Business Representative
*Must represent a Business in South San Francisco Business Name:
Conference Center Authority -Community Representative
Conference Center Authority -Hotel Representative*
*Must represent a Hotel in South San Francisco Hotel Name:
Cultural Arts Commission
Equity and Public Safety Commission
Housing Authority
Housing Authority Tenant Commission*
*Must be a resident of the Housing Authority
Library Board
Measure W Citizens' Oversight Committee
Parking Place Commission
Parks & Recreation Commission
Planning Commission
Traffic Safety Commission
APPLICANT INFORMATION
Full Name: Bawa Anita R
Last First M.I.
Address: 3
District:
Street Address (Select One)
South San Francisco CA 94080
City
Telephone: Emai
1 The City of South San Francisco
Office of the City Clerk
400 Grand Avenue
South San Francisco, CA 94080
CALIFORNIA (650) 877-8518
SUPPLEMENTAL QUESTIONNAIRE
Why are you interested in serving as a Boards and Commissions member? What do you feel you could contribute?
I live and work in South San Francisco (SSF) over 20 years and feel part of the SSF community and like to see the city to continue to grow and vibrate as have done in the past.
I am professional scientist and executive leader in Pharmaceutical industry where | learnt to work hard, go for passion, and return back to community.
I am current board member of the Hemophilia where I sever as treasurer and managing the fund raising activities.
I believe I will bring my board expertise, new ideas, and leadership skills to enhance the team.
What qualifies you for this appointment?
I am current board member.
I live in SSF
I have education in leadership, management, finance, and passion to design and build manufacturing and Quality Control labs specially in SSF.
I am professional auditors and reviewer and approvers of the internal and external documents.
I have outstanding public speaking skills and presented at large conference setting.
What is your vision for growth in South San Francisco?
I would like SSF to be known not just for biotech birth also for IT, Al, Finance and best city to live and work in the Bay Area. The city for everyone can live happy, healthy, and clean environment.
Build more affordable units, great parks, road well maintains, no crime, no illegal dumping, and many community events.
My dream that other cities admire us and learn from us what works in SSF and we are role model for other cities. Also we maintain within our budget and provide excellent services to our community.
2 The City of South San Francisco
ffice of the City Cler
400 Grand Avenu
South San Francisco, CA 94080
CALIFORNIA (650) 877-8518
SUPPLEMENTAL QUESTIONNAIRE
What community activities are you presently involved in, or have been in the past? served for Boys and Girls club. I am current board member. I support fund raising activities for Hemophilia. I served food banks and Glide Memorial diner in SF Are you currently receiving any form of compensation from the City for work performed? •YES • NO If yes, please explain:
Do you have any relatives serving on Council, Boards, Commissions, or Committees or are otherwise employed by the City of South San Francisco? • YES • NO Name: Position: Relationship:
WORK EXPERIENCE
Employer: Allogene Therapeutic South San Francisco
City:
Job Title: Site Head for Quality From: Sept 2019 To: Present Responsibilities:
Accountable for all quality functions from raw materials to final products Employer: City:
Job Title: From: To:
Responsibilities:
3 The City of South San Francisco
= 8 Office of the City Clerk
400 Grand Avenue
South San Francisco, CA 94080
CALIFORNIA (650) 877-8518
EDUCATION
School: University of San Francisco San Francisco
City:
1998 To: 2000 MBA
From: Degree:
School: St Mary's College Moraga
City:
1994 To: 1996 BA
From: Degree:
DISCLAIMER AND SIGNATURE
Signature Date: 7/3/2024
I certify mamous arto appucanon are complete and true. I agree and understand that any mis-statement of material fact will cause me to forfeit all rights to appointment to a Commission, Board, or Committee with the City of South San Francisco.
Applications are accepted on a continuous basis and will remain valid 1 year from the date of submission. If you are selected to serve on a Board or Commission, you may be required to file an Annual Statement of Economic Interest (FPPC Form 700) and bi-annual Ethics Training (AB1234).
OFFICIAL USE ONLY
Received By:
submision D7/3/24
4 ANITA BAWA
South San Francisco. CA
SUMMARY OF QUALIFICATIONS
Strategic and Managerial Leadership:
• Over 20 years of Manufacturing and Quality experience in the Cell and Gene therapy, biotechnology, and pharmaceutical industry
• Designed Cell and Gene Therapy Quality Control labs and qualified site for the production • Led large and diverse cross functional organizations both in Quality and Production •
Led over $125 Million new QC Building Project from Design Phase to move in labs over four years • Implemented Laboratory MODA, MES, LabWare, EMPOWER, SMART QC, SAP for Stability, and Quality Systems for Deviation (DevCom and Veeva) and Protocols/Validation (Valgensis) • Implemented Key Performance Indicator metrics to assess the health of the organization •
Led EU compliance strategy for the entire site to meet Clinical Trial Application (CTA) requirements • Led project to reduce 20% of cost of goods by utilizing capacity model tools for resources, non-value activities to reduce testing, and manage inventory to reduce the materials costs • Managed external contract labs routine testing and qualification and validation activities. • Board of Director and Treasurer of Hemophilia Foundation to serve the Northern California Regulatory, Quality, and Compliance:
• Extensive experience as the host, escort, and subject matter expert (SME) during Health Authority GMP and PAI inspections including FDA, EMA, HC, ANVISA, PMDA, CFDA, and MFDS and client audits • Active participation on global SOPs, quality standards, and metrics to ensure site alignment with other sites •
Authored responses to Health Authority requests related to IND, BLA submissions and Deficiency Letters Sponsored Critical Deviation Review Board team to assess major and critical deviations, CAPAs, and trends • Sponsored and led deviation reduction program and formed team to close >90% DRs and CAPAS within due dates and 20% decrease over year by proactively revising SOPs and providing training on "Why" • Sponsored Data Integrity (DI) Team to assess analytical instruments and systems to address gaps and provided training on audit trails. Active member of DI team for the site • Sponsored and lead Quality Improvement initiative to assess method validation and close gaps • A Certified Quality Auditor and Quality Professional (QP) and conducted CMO, Supplier, Internal, External audits within US, EU and Asia. Worked with QP to resolve EU gaps for the sites • Extensive experience with contract manufacturing (CMO, CDMO) both as a client and as a provider. • Experienced with Biologic and Cell & Gene products; batch release; field recalls; aseptic filling/clean rooms Technical Expertise:
• Set up Cell and Gene therapy Manufacturing site from green filed to clinical production within 2 years • Qualified facility, utility, equipment, and tech transfer from one site to another with comparability protocols Strong technical knowledge about cell based, micro, viruses, and PCR assays for cell therapy products • Enhanced Stability, Critical Reagents, and Standards/Controls program at site by implementing SAP and monitoring stability and assay control charts data on quarterly basis to take immediate action • Responsible for the method transfers of over 25 assays to various global sites and health authorities Page | 1
• Active member of PDA, BPOG, and ASQ and presented at multiple conferences related to microbial topics
PROFESSIONAL EXPERIENCE
Allogene Therapeutic - Newark, CA Sept 2019 - Present
Site Head for Quality
Accountable for all quality functions from raw materials to final product release at Allogene and quality oversight for Mfg, Supply Chain, Validation, Facility and Engineering, and Quality Control functions • Design and build state of the art Chimeric Antigen Receptor (CART) Cell Theory production site from green filed to start of the clinical runs and tech transfer the processes and methods • Build quality and IT systems- MES, LIMS, MODA, Veeva and generated over 1000 documents • Qualify facility, utility, and equipment/analytical instruments to meet US and EU requirements • Develop Aseptic Process Simulation for Critical materials, Drug Substance, and Drug Product • Implement Quality Systems, Management Review, and Quality Review Board • Responsible for all Quality Assurance Operations from raw material to product dispositions • Oversee external contract labs to support raw materials qualification and routine testing • Build and maintain high performing teams (QA, QC, Validation) to meet the company objectives and timelines from development to commercialization
• Active member of the CMC and Supply Chain team to support IND and CTA submissions Page | 2
Sutro Biopharma - San Carlos, CA Jan 2019 - Aug 2019
Head of Quality Control and Compliance Strategic Initiatives Accountable for all quality control functions from raw materials to final product release at Sutro and quality oversight for CMO and contract labs. In addition, responsible for EU compliance for Phase I products for the site and ensure Quality System adherence to Good Clinical Practices. • Provide scientific and technical guidance on all laboratory management issues, stability programs, product launches, and project teams. Ensure QC procedures are aligned with CRs and regulatory global and internal guidelines
• Build and maintain high performing team to meet the company objectives and timelines • Partner with internal Manufacturing, Analytical Development (AD), Process Development (PD), and Supr Chain to develop stability program and tech transfer strategies, enhance supplier management and oversigl of Sutro's products (antibody, small molecules, and drug linker). • Collaborate with partners (EMD Serono and Celgene) in establishing a multi-year strategy in manufacturit and quality oversight of MUCI and BCMA to support GLP Tox and Phase I studies respectively. • Led selection of the QP and development of EU quality related launch plan for Sutro's first ADC products Active member of the CMC and Supply Chain team to support IND and CTA submission Bayer Healthcare - Berkeley, CA
Head of Quality Control (Microbiology & Virology and Analytical & Chemistry) Nov 2016- Jan 2019 Director/Sr. Director of Quality Control, Microbiology & Virology Oct 2012- Oct 2016 Provide quality oversight in all aspects of the production of 3 commercial and various clinical products, especially with regards to GMP raw materials, lot release testing, assay development, method validation, and deviation investigation. Using strategic planning and leadership, ensure that lot release cycle time is reduced; non-value added activities are eliminated; innovation and new technology are implemented to reduce cost as well as maintain a well-talented, efficient, and productive workforce. • Directed a group of 225 people in 22 labs located in 5 different buildings that perform over 200 different assays including raw materials, environmental monitoring, chemistry, microbiology, virology and biochemistry for Factor VIII and recombinant proteins in both clinical and commercial environments to support the lot release
• Directed efforts that eliminate significant Quality Systems backlog and created conformance team to drive on time closure of deviations, CAPAs, Risk Assessments, and Change Control Records to enhance compliance and meet our patients' needs.
• Led $100 Million new QC Building Project from Concept Design Phase to completion as a user. Actively worked with Engineering, Quality, Regulatory, and Validation to qualify new building for GMP operations • Supported new product launch with submission to agencies and transferred analytical methods and technologies to other Bayer sites - ELB and LEV
• Oversaw $45M budget for the department and developed strategic plan to reduce the budget by 10% over a 3-year period by managing the resources, inventory, and removing non-value added activities and testing.
Genentech - South San Francisco, CA
Senior Manager of QC Microbiology, Environmental, and Inspection Nov 2008 - Oct 2012 Senior Manager of QC Microbiology Dec 2005 - Nov 2008
Directed the activities of the Quality Control testing related to Microbiology, Environmental Monitoring, and Raw Materials for the site.
• Managed over 37 people including 6 direct reports: Managers, Pharmaceutical, and Microbiologists • Managed QC discrepancy management team to ensure deviations and CAPAs were closed within due dates • Reviewed and approved method validation and study protocols and reports for technical assessments • Implemented process improvement tools to achieve Class A - 5S, Vendor Management Inventory (VMI, Process Based Leadership (PBL) scorecard, Governance model, and Operational Excellence (OE). • Implemented Utilities and Facilities Committee to review and assess water system health and facility • Implemented new shift structure to provide equivalent coverage without swing shift and cross trained Genentech - South San Francisco, CA
Manager of Biochemical Manufacturing July 2004 - Nov 2005 Group Manager of Biochemical Manufacturing Oct 2001 - June 2004 Senior Supervisor of Fermentation
Feb 1997 - Sept 2001
Directed the activities of the Manufacturing Operations to produce E.coli and CHO clinical and commercial products accordance with GMP and Genentech guidelines.
• Managed >42 people at various levels- supervisors and associates with 24/7 operations • Collaborated with Facility, Automation, Manufacturing and Process Sciences, Clinical and Marketed Quality Assurance, Quality Control, and Regulatory groups to meet the production goals and resolve pending issues to release the product
• Sponsored two value stream projects: Bill of Materials for parts and changeover to gain efficiency • Created and managed $5.5 million Gross Functional Expense (GFE) and Functional Area Equipment (FAE) budget within 3% variance
• Developed and implemented Manufacturing Review Group in Biochemical Business Unit to provide support to Operations with on-line batch record review. This ensured timely and accurate information was recorded to prevent discrepancies and reduce standard lead time resulting in lot release from 14 to 8 Irwin Memorial Blood Center - San Francisco, CA
Research Technologist Aug 1995 - Jan 1997
Supervisor of Component Laboratory Sept 1990 - July 1995
EDUCATION
University of San Francisco - San Francisco, CA
Masters of Business Administration (MBA)
Saint Mary's College - Moraga, CA
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Bachelor in Management and Marketing (BA)
Training, Seminars, Conferences, and Membership
Certified Quality Auditor (CQA) America Society of Quality Bayer Certified Quality Professional (COP) Program NSF, DBA Juran's DMAIC Process and Six Sigma Tools- Green Belt The Juran Institute Microbial Data Deviation and Investigation (presenter) Pharmaceutical Microbiology Forum Good Laboratory Practices (presenter) International Pharmaceutical Academy Co-author of articles in Microbiology on bioburden and mold Journal of Pharmaceutical Science &Technology
PROFESSIONAL MEMBERSHIP
• Board of Director and Treasurer for Northern California of Bleeding Disorder since 2021
• America Society of Quality (ASQ)
• Pharmaceutical Microbiology Forum (PMF)
Parenteral Drug Association (PDA)
BioPhorum Operations Group (BPOG)
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