Another New Employee In Manufacturing.........last year

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kmall
Posts: 754
Joined: Thu Mar 21, 2019 3:57 pm

Another New Employee In Manufacturing.........last year

Post by kmall » Sat Mar 19, 2022 5:07 am

William Garzon-Rodriguez - Associate Director Drug Product Manufacturing, Geron Corporation
Parsippany, New Jersey

Hired April 2021 - 4/22/2021 - FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 220,000 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. William Garzon-Rodriguez was one of these newly hired employees.

Former employers: Amgen, JNJ, West Pharmaceutical Services, Prometic, Auxilium Pharmaceuticals Inc., Vaccinate Services

Geron: Assistant Director Drug Product Manufacturing, Geron Corporation
Apr 2021 - Present 1 yr
Lead the drug product manufacturing function in developing and executing CMC strategies across the product life cycle for an oligonucleotide therapeutic, including manufacturing, process development and technology transfer to ensure that processes and products are manufactured in compliance with all regulations and guidelines to support late-stage clinical studies, product licensure, and commercialization.

Oversight and direction of Geron’s drug product contract manufacturers and raw material suppliers. Develop and maintain relationships with these vendors.

An emphasis on aseptic processing, sterilization technologies, container closure and validation.
Person-in-plant support as needed to oversee production activities and CMO management.
Prepares, reviews, and edits process transfer, qualification, and validation protocols, technical reports, and CMC regulatory documentation.

Process design, development and validation of the manufacturing process.
Management of the development of the 2nd generation of liquid Oligonucleotide lead Drug Product with CMO/CRO.

**Every so often a "new" employee remains undisclosed longer than others. William was "on the radar" for sometime now. His position is critical to the manufacturing/commercialization of Imetelstat. I think this except from above zeros in on that.....

"to ensure that processes and products are manufactured in compliance with all regulations and guidelines to support late-stage clinical studies, product licensure, and commercialization."

William is the first known Geron Manufacturing employee based on the East Coast. In his Geron job description, it clearly states that he works closely with the CMO (Dr. Aleksandra Rizo) and CRO (Parexel - Parexel International Headquarters - Newton, MA; Parexel International - Hackensack, NJ; Parexel International
Early Phase Clinical Unit - Baltimore, MD):

"Management of the development of the 2nd generation of liquid Oligonucleotide lead Drug Product with CMO/CRO."

Expect more hires by Geron in Manufacturing in the very near future. -Kmall

kmall
Posts: 754
Joined: Thu Mar 21, 2019 3:57 pm

Re: Another New Employee In Manufacturing.........last year

Post by kmall » Sat Mar 19, 2022 5:40 am

William Garzon-Rodriguez's experience with Manufacturing/Commercialization includes:

"Pre and post-approval CMC technical support for STELARA™ and SIMPONI™ (JnJ), XIAFLEX (Endo), and RYPLAZIM (Prometic)"

STELARA: http://www.janssen.com/immunology

SIMPONI: http://www.janssen.com/immunology

XIAFLEX: https://www.xiaflex.com/

RYPLAZIM: https://www.empr.com/drug/ryplazim/

**Also of note: While William Garzon-Rodriguez is listed as being employed by JNJ from 2004 - 2009, both STELARA and SIMPONI were developed by Janssen, a JNJ subsidiary. Dr. Aleksandra Rizo was employed by Janssen (JNJ) from 2008 - 2018. Whether or not these two current employees of Geron crossed paths while at Janssen is unclear, they are both now in the final development stages of the Manufacturing/Commercialization process of Imetelstat at Geron in New Jersey. -Kmall

kmall
Posts: 754
Joined: Thu Mar 21, 2019 3:57 pm

Re: Another New Employee In Manufacturing.........last year

Post by kmall » Sat Mar 19, 2022 12:45 pm

Known current Geron Employees as of 3/19/2022 and their initial hiring dates –
* Former Janssen employee
+ Part-time or Consultant

Management:
1 - CEO – Dr. John A. Scarlett, MD - 2011
2 - CFO – Olivia K. Bloom - 1994
3 - CAO – Melissa A. Kelly Behrs – 1998
4. – CBO – Edward Koval - 2021
5 - COO – Andrew J. Grethlein - 2012
6 - CCO* – Anil Kapur - 2019
7 - CMO* – Aleksandra Rizo, MD - 2019
8 - CLO – Stephen N. Rosenfield - 2011

Clinical – Operations, Science, Development:
Aleksandra Rizo*(6), MD – CMO – 2019
9 - Laurie Sherman* – VP Clinical Operations – 2019
10 - Faye Feller* - VP Clinical Development – 2019
11 - Souria Dougherty* - Ex Director Clinical Science - 2019
12 - Tymara Berry – Ex Director Clinical Development - 2020
13 - Sheetal Shah – Sr Director – 2020
14 - Denise Redding – Director - 2021
15 - Jeff Ryel – Director Clinical Operations - 2020
16 - Karie Arnold – Director Clinical Operations – 2021
17 - Brandie Jonas – Director Program Management – 2019
18 – Carolina Jacobs – Sr Project Manager - 2012
19 - Daria Zielinska – Sr Scientist – 2001
20 - Ron Pruzan – Principal Scientist – 2010
21 – Yelena Polonskaya – Sr Research Associate - 2001
22 - Barbara Mandelkow (Germany) Lab Assistant - 2017
23 - Mebratu Gebreyesus(+) - Sr Development Associate - 2010
(currently employed at Bayer, Celtheon and Geron)
24- Kerry Mundt(+) – CT Assistant – 2010
(currently employed by Pharmacyclics/Abbvie and Geron)

Pharmacovigilance and Drug Safety/Information:
25 - Patti N. – Ex Director Drug Safety – 2020
26 – Annat Ikin - Director Medical Writing, Geron Corporation – Nov 2021

Business Development:
Melissa A. Kelly Behrs (3) – Chief Alliance Officer – 2014
Edward Koval (4) – CBO - 2021
Anil Kapur* (6) - COO - 2019
27 - Lynn Bodarky – VP Business Development – 2019
28 - Denise Meyer – VP Medical Affairs – 2021
29 - Helen Lee – Sr. Reporting Analyst - 2012
30 - Anthony Kuczynski – Analyst - 2019

Finance:
Olivia K. Bloom (2) – CFO – 1994
31 - Karen Boyce – VP -2008
32 - Andrew Good – Ex Director – 2006
33 - Lilly Huang – Ex Director, CPA - 2019
34 - Gilian Fong – Director – 2021
35 - Vivian Pham – Sr. Accountant – 2006
36 – Iasko Cable – Sr. Clinical Trial Accountant – 2019
37 – Dave Clark – CPA, Corporate Controller - 2022

Data Management:
38 - Dan Miller – Sr. Director – 2019
39 - Rana F.* – Director, Statistical Programming - 2020
40 - Sridevi Sridhar, CCDM – Associate Director – 2021

Manufacturing:
41 - Patrick Murphy – VP Manufacturing – 2019
42 - Eric Mueller – Director – 2019
43 - Leslie C. – CMC Director - 2021
44 - Bharat Baral* – CMC Manager – 2021 & 2011
45 - William Garzon-Rodriguez* - Associate Director Drug Product Manufacturing, Geron Corporation – April 2021
46 - Tim Tickner – Director, Supply Chain Management, Geron Corporation – Jan 2022

Regulatory:
47 - Sharon McBain* - VP Global - 2019
48 - Shirin Mirshamsi* – Director EU – 2019
49 - Ilesh Sanathra* - Director Global – 2020
50 - Nick Lyon – Director – 2020
51 – Ronan Balicanta* - 2022

Biostatistics:
52 - Ying Wan* – VP - 2019
53 - Libo Sun* – Director - 2019

Quality Assurance and Quality Control:
54 - Denise Grippo – VP Quality and Compliance – 2019
55 - Samantha Taylor – QA Manager, Document Control – 2007
56 - Joe Denton – Director – 2019
57 - John Brenner – Director – 2020
58 - Damanjit Singh – Sr Manager – 2018
59 - Willie Mobley – Materials/Document Specialist - 2007
60 - Leah Wood – Manager – 2021
61 - Murugappa Vedachalam (+) – QA/QC/CMC Consultant - 2019

Legal and Intellectual Property:
Stephen L. Rosenfield (8) – CLO – 2011
62 - Pamela Smith – Associate General Counsel - 1999
63 - Christopher Johnson – Director - 2019
64 - Laura Reederson – Director - 2020
65 - Leslie Mooi – VP IP – 2007
66 - Abby B. – Sr Patent Paralegal - 2014
67 - Cheryl Northern – Sr. Contracts Manager – 2007
68 – Brittney Hernandez – Contracts Manager – 2021

Facilities Operations and Information Technology:
69 - Michael Yamada – VP -2007
70 - Jyoti Shetty – Sr Director IT – 2021
71 - Miguel Hundelt – Systems Administrator – 2018
72 – Julian Cornejo - Systems Administrator - 2021
73 - Briana Martinez – Ex Assistant - 2006
74 - Julia Mensing – Ex Assistant – 2011
75 - Stacie W. – Ex Assistant - 2020
76 - Mia Pham – Office Manager - 2020

Human Resources:
77 - Shannon Odam – HR Executive -2019
78 - Stephanie Dellari – Director - 2004
79 - Susan Finan – Employee Benefits – 2021
80 - Marisa Cerniglia - Manager, People Operations at Geron Corporation – Oct 2021
81 – Jennifer Allen - Associate Director, Talent Acquisition, Geron Corporation – Jan 2022
82 – Fiona McAuliffe – Talent Acquisition Associate – March 2022

**Considering that William Garzon-Rodriguez* - Associate Director Drug Product Manufacturing, was involved with the Development/Commercialization of two approved drugs (STELARA & SIMPONI) for Janssen while employed by JNJ, that would make Mr. Garzon-Rodriguez the 14th ex-Janssen employee currently residing under the Geron roof that we know of. -Kmall

kmall
Posts: 754
Joined: Thu Mar 21, 2019 3:57 pm

Re: Another New Employee In Manufacturing.........last year

Post by kmall » Sat Mar 19, 2022 1:24 pm

***Correction:

William Garzon-Rodriguez* - Associate Director Drug Product Manufacturing - Parsippany, New Jersey, is the second*** Geron Manufacturing employee based on the East coast.

Leslie C. – CMC Director, Geron Corporation also hired in April 2021 is based in Somerset, New Jersey. -Kmall

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