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Posted : Tuesday, October 24, 2023 05:54 AM
Sutro Biopharma, Inc.
is seeking a versatile Sr.
Manager of Quality Control Microbiology and Environmental Monitoring (EM) who will work within a dynamic team environment to support GMP operations.
Primary function will be oversight of QC activities to support testing and data review of product and cleaning samples as well as the Environment and Utility Monitoring Program.
The position will also be required to write documents related to Microbial results and EM trends, and participate in deviation/OOS investigations, and implement CAPAs and change controls per GMP requirements as needed.
Excellent verbal and written communication skills are essential for success in this position.
In addition, this role manages and provides quality oversight for a Contract Testing lab.
Responsibilities: This individual will be responsible for supporting QC Microbiology and Environmental Monitoring (EM) operations in Sutro Biopharma’s cGMP Manufacturing Facility.
Primary oversight will be QC activities related to managing microbiology lab in support of in-process and release testing, cleaning samples, Utility and Environmental Monitoring testing.
At a minimum: Manage, coordinate, and prioritize the testing within QC Microbiology to support in-process and release testing of products and cleaning samples.
Manage, coordinate, and prioritize the testing within QC Microbiology and/or via Contract Testing Organization (CTO) for Utility and Environmental Monitoring Program.
Manage and perform data review and approval to ensure review is completed in a timely manner.
Provide subject matter expertise for TOC, pH, Bioburden and Endotoxin assays.
Drive and Prepare Environmental Trend Reports, Method Verification Protocols & Reports, SOPs, Special Studies, etc.
Support and lead Deviations/OOS/OOL investigations as it relates to microbial contamination and EM excursions and implement appropriate CAPA and Change Control Pro-actively identify opportunities for improvement in QC Microbiology laboratory operations and Environmental and Utility Monitoring.
Actively create and establish processes and procedures to ensure cGMP compliance and operational efficiency within QC Ensure inspection readiness and alignment with compendial methods and regulatory expectations for microbiology testing.
Work closely within QC and cross-functionally with QA, Manufacturing, and Tech Transfer Departments to ensure project timelines are met.
Communicate data both verbally at group meetings and through written documents and reports.
Support new product introduction with regards to bioburden / endotoxin method suitability and verifications.
Including oversight and strategy related to protocol and report generation.
This individual will be expected to effectively follow Sutro Biopharma’s SOPs and policies, and cGMP compliance regulations.
Additionally, he/she should be able to independently manage review times to meet Sutro’s priorities and communicated timelines.
Qualifications: BS or MS degree in Microbiology or related field 9+ years of with BS or 7+ years with MS in QC experience in a cGMP regulated manufacturing environment is required.
2+ of management/leadership experience is required.
Knowledge in ICH/USP/EP/ISO standards and guidelines as it relates to QC Microbiology and Environmental/Utility Monitoring.
Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner.
Balanced decision making that demonstrates critical thinking.
Able to establish priorities and maintain progress even under uncertain circumstances.
Strong verbal and written communication skills essential.
Strong communication, prioritization and organizational skills.
Ability to utilize multiple word-processing and database applications.
Sound exciting? Apply today and join our team! Sutro Biopharma, Inc.
requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment.
As required by applicable law, Sutro will consider requests for reasonable accommodations.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions.
Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team.
Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability, or citizenship status.
We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California-based locations will be [$170,000-190,000] (not including bonus, equity, and benefits).
The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
About Sutro Biopharma Sutro Biopharma, Inc.
, is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients.
Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience.
Sutro has multiple clinical-stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies.
A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation.
Sutro is headquartered in South San Francisco.
For more information, follow Sutro on social media @Sutrobio, or visit www.
sutrobio.
com.
is seeking a versatile Sr.
Manager of Quality Control Microbiology and Environmental Monitoring (EM) who will work within a dynamic team environment to support GMP operations.
Primary function will be oversight of QC activities to support testing and data review of product and cleaning samples as well as the Environment and Utility Monitoring Program.
The position will also be required to write documents related to Microbial results and EM trends, and participate in deviation/OOS investigations, and implement CAPAs and change controls per GMP requirements as needed.
Excellent verbal and written communication skills are essential for success in this position.
In addition, this role manages and provides quality oversight for a Contract Testing lab.
Responsibilities: This individual will be responsible for supporting QC Microbiology and Environmental Monitoring (EM) operations in Sutro Biopharma’s cGMP Manufacturing Facility.
Primary oversight will be QC activities related to managing microbiology lab in support of in-process and release testing, cleaning samples, Utility and Environmental Monitoring testing.
At a minimum: Manage, coordinate, and prioritize the testing within QC Microbiology to support in-process and release testing of products and cleaning samples.
Manage, coordinate, and prioritize the testing within QC Microbiology and/or via Contract Testing Organization (CTO) for Utility and Environmental Monitoring Program.
Manage and perform data review and approval to ensure review is completed in a timely manner.
Provide subject matter expertise for TOC, pH, Bioburden and Endotoxin assays.
Drive and Prepare Environmental Trend Reports, Method Verification Protocols & Reports, SOPs, Special Studies, etc.
Support and lead Deviations/OOS/OOL investigations as it relates to microbial contamination and EM excursions and implement appropriate CAPA and Change Control Pro-actively identify opportunities for improvement in QC Microbiology laboratory operations and Environmental and Utility Monitoring.
Actively create and establish processes and procedures to ensure cGMP compliance and operational efficiency within QC Ensure inspection readiness and alignment with compendial methods and regulatory expectations for microbiology testing.
Work closely within QC and cross-functionally with QA, Manufacturing, and Tech Transfer Departments to ensure project timelines are met.
Communicate data both verbally at group meetings and through written documents and reports.
Support new product introduction with regards to bioburden / endotoxin method suitability and verifications.
Including oversight and strategy related to protocol and report generation.
This individual will be expected to effectively follow Sutro Biopharma’s SOPs and policies, and cGMP compliance regulations.
Additionally, he/she should be able to independently manage review times to meet Sutro’s priorities and communicated timelines.
Qualifications: BS or MS degree in Microbiology or related field 9+ years of with BS or 7+ years with MS in QC experience in a cGMP regulated manufacturing environment is required.
2+ of management/leadership experience is required.
Knowledge in ICH/USP/EP/ISO standards and guidelines as it relates to QC Microbiology and Environmental/Utility Monitoring.
Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner.
Balanced decision making that demonstrates critical thinking.
Able to establish priorities and maintain progress even under uncertain circumstances.
Strong verbal and written communication skills essential.
Strong communication, prioritization and organizational skills.
Ability to utilize multiple word-processing and database applications.
Sound exciting? Apply today and join our team! Sutro Biopharma, Inc.
requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment.
As required by applicable law, Sutro will consider requests for reasonable accommodations.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions.
Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team.
Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability, or citizenship status.
We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California-based locations will be [$170,000-190,000] (not including bonus, equity, and benefits).
The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
About Sutro Biopharma Sutro Biopharma, Inc.
, is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients.
Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience.
Sutro has multiple clinical-stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies.
A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation.
Sutro is headquartered in South San Francisco.
For more information, follow Sutro on social media @Sutrobio, or visit www.
sutrobio.
com.
• Phone : NA
• Location : San Carlos, CA
• Post ID: 9016636114
