Senior Manager, GMP Quality Assurance
Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre's pipeline includes extended half-life antibodies targeting a4ß7, TL1A, and IL-23.
Role Summary:
Spyre Therapeutics is seeking an exceptional Sr. Manager, GMP Quality Assurance to join our Quality team. This individual will have the unique opportunity to assist the Sr. Director, GMP QA in developing, monitoring, and maintaining all aspects of a quality system as it relates to cGMP requirements for a development and clinical phase organization pursuing multiple biologic monoclonal antibody candidates. This person will be responsible for Batch Release, Change Control, Qualifications, Deviations and CAPAs as they relate to the CMOs and the production clinical drug substance and drug product. This role reports to the Sr. Director of GMP QA.
Key Responsibilities:
Manage and coordinate Quality Assurance related activities relating to the CMOs and TechOps teams as well as support the QA team in a regulated environment
Support implementation of the Spyre Therapeutics' quality strategy and culture
Perform batch record review and product release activities to ensure all products released meet regulatory standards
Assist with the creation of quality metrics related to the trending of non-conformance reports, CAPAs, and complaint investigations
Review and approve master batch records, analytical methods, validation and cleaning protocols and reports, standard operating procedures (SOPs), change control documents, Quality Events, etc. as needed
Review Stability Protocols and resulting Data and Reports for compliance when required
Work with Quality Operations to ensure compliance with the company's corporate Quality Management System (QMS)
Effectively collaborates with departments (i.e. Technical Operations, CMC Regulatory and Clinical) on various projects/improvements when input/participation from Quality is needed
Participate in specific Quality related projects in accordance with the company's goals and business objectives
Drive the spirit of teamwork across all functions by supporting a team approach with focus on our patients being the top priority
Support regulatory authority inspections and partner audits
Align daily actions with department goals and company culture
Other duties as assigned
Ideal Candidate:
Bachelor's degree in a scientific discipline with 8 plus years in the Pharmaceutical/Biotechnology industry (an equivalent combination of education and experience may be considered)
Proven ability to apply cGMP regulations 21 CFR Part 11, 210, 211, 600 and good documentation practices to daily activities governing the Spyre activities
Clinical product batch release experience required; commercial product release is a plus
Experience in investigations writing and review required
Experience with third party testing vendors and quality control release assays is a plus
Knowledge of a biologics manufacturing and fill/finish environment strongly preferred
Detail oriented with strong written and verbal communication skills
Ability to work independently with minimal direction, within prescribed guidelines, or as a team member
Ability to work well in a deadline-driven environment
Travel may be required up to 15% of the time
What We Offer:
Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
Unlimited PTO
Two, one-week company-wide shutdowns each
Commitment to provide professional development opportunities.
Remote working environment with frequent in-person meetings to address complex problems and build relationships.
The expected salary range offer for this role is $165,000 to $182,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.
Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain "@spyre.com." We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.
Apply Now
Role Summary:
Spyre Therapeutics is seeking an exceptional Sr. Manager, GMP Quality Assurance to join our Quality team. This individual will have the unique opportunity to assist the Sr. Director, GMP QA in developing, monitoring, and maintaining all aspects of a quality system as it relates to cGMP requirements for a development and clinical phase organization pursuing multiple biologic monoclonal antibody candidates. This person will be responsible for Batch Release, Change Control, Qualifications, Deviations and CAPAs as they relate to the CMOs and the production clinical drug substance and drug product. This role reports to the Sr. Director of GMP QA.
Key Responsibilities:
Manage and coordinate Quality Assurance related activities relating to the CMOs and TechOps teams as well as support the QA team in a regulated environment
Support implementation of the Spyre Therapeutics' quality strategy and culture
Perform batch record review and product release activities to ensure all products released meet regulatory standards
Assist with the creation of quality metrics related to the trending of non-conformance reports, CAPAs, and complaint investigations
Review and approve master batch records, analytical methods, validation and cleaning protocols and reports, standard operating procedures (SOPs), change control documents, Quality Events, etc. as needed
Review Stability Protocols and resulting Data and Reports for compliance when required
Work with Quality Operations to ensure compliance with the company's corporate Quality Management System (QMS)
Effectively collaborates with departments (i.e. Technical Operations, CMC Regulatory and Clinical) on various projects/improvements when input/participation from Quality is needed
Participate in specific Quality related projects in accordance with the company's goals and business objectives
Drive the spirit of teamwork across all functions by supporting a team approach with focus on our patients being the top priority
Support regulatory authority inspections and partner audits
Align daily actions with department goals and company culture
Other duties as assigned
Ideal Candidate:
Bachelor's degree in a scientific discipline with 8 plus years in the Pharmaceutical/Biotechnology industry (an equivalent combination of education and experience may be considered)
Proven ability to apply cGMP regulations 21 CFR Part 11, 210, 211, 600 and good documentation practices to daily activities governing the Spyre activities
Clinical product batch release experience required; commercial product release is a plus
Experience in investigations writing and review required
Experience with third party testing vendors and quality control release assays is a plus
Knowledge of a biologics manufacturing and fill/finish environment strongly preferred
Detail oriented with strong written and verbal communication skills
Ability to work independently with minimal direction, within prescribed guidelines, or as a team member
Ability to work well in a deadline-driven environment
Travel may be required up to 15% of the time
What We Offer:
Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
Unlimited PTO
Two, one-week company-wide shutdowns each
Commitment to provide professional development opportunities.
Remote working environment with frequent in-person meetings to address complex problems and build relationships.
The expected salary range offer for this role is $165,000 to $182,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.
Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain "@spyre.com." We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.
Apply Now