PDA Industry and Honor Award Winners

Class of 2023

Honorary Membership*

PDA's most prestigious award, conferring lifetime membership benefits to the recipient. The award is given in recognition of very long service, of a very significant nature, to PDA.

She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.

Frederick Carleton Award*

This award is designated for a past Board member whose services on the Board are determined by his/her peers as worthy of high recognition. It is presented as a tribute to lifetime contributor Fred Carleton.

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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Gordon Personeus Award*

This Award is intended to honor a PDA member for his or her long-term activities and/or volunteer contributions that are of noteworthy or special importance and have positively impacted PDA in several areas over time. It is presented in memory of the late Gordon Personeus, past PDA President and long-time volunteer.

About Amelia (Amy) Mutere

Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Amelia (Amy) Mutere

Michael Korczynski Award*

This Award is presented to recognize contributions to PDA’s international activities. It is named for Michael S. Korczynski in recognition of the contributions he made toward the development of PDA’s international activities.

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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James P. Agalloco Award

This award is presented annually to the PDA TRI faculty member who exemplifies outstanding performance in education. The selection is based on student and faculty evaluations. It is named for James P. Agalloco in honor of his work in developing the PDA education program.

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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Martin VanTrieste Pharmaceutical Science Award*

This award recognizes a volunteer’s outstanding contributions that have advanced the pharmaceutical sciences. It is presented in honor of past Board Member and long-time contributor Martin VanTrieste.

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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Edward Smith PDA Packaging Science Award*

This award was created to recognize outstanding contributions to Pharmaceutical Packaging Science. It is presented in honor of Edward Smith and his long-term contributions to pharmaceutical packaging science.

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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Distinguished Service Award*

Four to six awards are typically given in recognition of volunteers' special acts, contributions, or service over the last year that have contributed to the success and strength of PDA. Examples of the types of activities that are recognized include service as members and leaders of PDA Program Planning committees, Task Forces, Interest Groups, and Chapters.

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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Frederick Simon Award

This award is presented annually for the best paper published in the PDA Journal of Pharmaceutical Science and Technology (JPST).  It is named in honor of the late Frederick D. Simon, a previous PDA Director of Scientific Affairs.

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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PDA Letter Article of the Year Award

This reward recognizes an article written by a PDA member during the preceding year that proved popular with PDA’s audience. In addition, the Managing Editor and the Editorial Committee agrees that the article represents quality work deserving of special recognition.

This year's award-winning article is "How to Establish Effective CCS with TR-90"

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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PDA Asia Pacific Appreciation Award

This award is given in recognition of special volunteer acts contributing to the success and strength of PDA in the Asia Pacific region.

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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PDA Europe Appreciation Award

This award is given in recognition of special volunteer acts contributing to the success and strength of PDA in Europe.

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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Outstanding Early Career Professional Award

This award is given in recognition of special volunteer acts contributing to the success and strength of PDA by an Early Career Professional

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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Service Appreciation Award

This award is given in recognition of activities performed on behalf of PDA and is awarded at the end of service of specific volunteer leadership positions, including:

  • The Board of Directors
  • Advisory Board Chairs (intended to be given after stepping down as immediate past chair but can be given earlier when service is cut short)
  • Interest Group Leaders
  • Chapter Presidents

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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PDA President’s Award

This Award recognizes a PDA staff member, typically excluding Senior Staff members, whose exemplary performance has contributed to PDA’s success during the previous year.

Amelia (Amy) Mutere

Mar 22, 2024, 13:19 PM
Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
Full name : Amelia (Amy) Mutere
First name : Amy
Last name : Mutere
Full Name : Amelia (Amy) Mutere
Job title or position name :
Company or organization :
Phone :
Email :
Twitter URL :
YouTube Video ID :
LinkedIn Url : https://www.linkedin.com/in/amelia-amy-mutere-20407011/
Sort ordinal :
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Categories :
  • 2023
  • PDA Honor Award
  • Service Appreciation Award
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