Manager, Quality Assurance GMP job at Crinetics Pharmaceuticals in CA
Title: Manager, Quality Assurance GMP
Location: US California
Job Description:
Crinetics is a pharmaceutical company based in San Diego, California, developingmuch-needed therapies for people withendocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine anda robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premierfully integratedendocrine company from discovery to patients.Joinour team as we transform the lives of others.
Position Summary:
The Manager, Quality Assurance GMPis primarily responsible for management and oversight of quality processes overseeing manufacturing and supportive operations in compliance with Good Manufacturing Practices(GMP).
EssentialJobFunctionsand Responsibilities:
Thesemayincludebut are not limitedto:
Serve as theGMP QA partner forthedevelopment programs, from early phase through validation
Review and approve analytical methodtransfer andvalidationprotocols andfinal reportsfor Drug Substance and Drug Product
Review and approve analytical methods and specifications, stabilityprotocolsandreports
Perform reviewand approvalof analytical and microbiological testing data for Drug Substance, Drug ProductIntermediatesand Drug Product
Perform batch record review and disposition related activities for Clinical and Commercial Supplies
Review and approve Master Batch Records, review CMO change controls and provide quality impact assessments relating to proposed changes
Coordinate Quality Events (Laboratory Investigations,Deviations, CAPAs) with CMOs and escalateto QA managementas appropriate
Oversee QA aspects of API, Drug Product and Packaging and Labeling Operations for Crinetics products
Represent QA in internal and external team meetings
Support QA team on internal and external GMP audits
Performand/or reviewimpact assessmentsand risk assessments
Write and review Standard Operating Procedures
Write internal investigations, as applicable; review external, CMOinvestigations as assigned
Compile metrics of Batch Disposition, deviations, CAPAs, as applicable
Perform vendor audits as assigned and support vendor lifecycle activities
Other duties as assigned
Education andExperience:
Required:
Bachelor’s degree in chemistry,engineeringor other scientific discipline
7 years of relevant experience in aregulatedGMP environment with 2 years of supervisory/leadership experience
Demonstratedknowledge of FDA/EMA/ICH standards and regulations.
Demonstratedknowledge of Risk Assessment and Root Cause Analysis (5 WHYs, FMEA)
Relevant analytical experience, including understanding and working knowledge of chromatography and chromatographic methods (i.e.HPLC, GC)
Equipment:working knowledge of relevant manufacturing and analytical testing equipment and instrumentation
Demonstrateability to effectively organize,prioritizeand work in a fast-paced environment
Demonstrate ability to function individually and in a team environment
Software Knowledge: MS Office, ERP systems
Preferred:
Soliddosageor drug substanceexperience is preferred, however, experience in other dosage forms with relevant experience is acceptable
Prior experience with Electronic QMS systems (Veeva preferred)
Physical Demands and Work Environment:
Physical Activities:Ona continuous basis, sit atdeskfora long periodof time;intermittently answertelephoneand write or use a keyboard to communicate throughwritten means. Somewalking andliftingupto 25lbs.maybe.The noise level inthe work environment istypically lowto moderate.The physical demands describedabove are representative of those that must be met by an employee to successfullyperform the essential functions andresponsibilities of this job.Reasonableaccommodations may be made to enable individualswith disabilities to perform theessential functions and responsibilities.
Laboratory Activities(if applicable):Biology and chemical laboratory environmentexperience needed.Environmental health and safety requirements also apply.
Travel:
You maybe requiredto travel for up to 5% of your time.
The AnticipatedBase Salary Range:
In addition to your base pay, our total rewards program consists of a discretionaryannualtargetbonus,stock options, ESPP, and 401k match.We also provide top-notch health insurance plans for employees (and their families) to include medical, dental,vision and basic lifeinsurance,20 daysof PTO, 10 paid holidays, and awinter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length ofexperienceandeducation. Crinetics Pharmaceuticals is a multi-stateemployer,and this salary range may not reflect positions that work in other states.Your recruiter can share more about the specific salary range during the hiring process.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer.We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary Range
The salary range for this position is: $116,000 - $145,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
Apply Now
Apply Now
Location: US California
Job Description:
Crinetics is a pharmaceutical company based in San Diego, California, developingmuch-needed therapies for people withendocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine anda robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premierfully integratedendocrine company from discovery to patients.Joinour team as we transform the lives of others.
Position Summary:
The Manager, Quality Assurance GMPis primarily responsible for management and oversight of quality processes overseeing manufacturing and supportive operations in compliance with Good Manufacturing Practices(GMP).
EssentialJobFunctionsand Responsibilities:
Thesemayincludebut are not limitedto:
Serve as theGMP QA partner forthedevelopment programs, from early phase through validation
Review and approve analytical methodtransfer andvalidationprotocols andfinal reportsfor Drug Substance and Drug Product
Review and approve analytical methods and specifications, stabilityprotocolsandreports
Perform reviewand approvalof analytical and microbiological testing data for Drug Substance, Drug ProductIntermediatesand Drug Product
Perform batch record review and disposition related activities for Clinical and Commercial Supplies
Review and approve Master Batch Records, review CMO change controls and provide quality impact assessments relating to proposed changes
Coordinate Quality Events (Laboratory Investigations,Deviations, CAPAs) with CMOs and escalateto QA managementas appropriate
Oversee QA aspects of API, Drug Product and Packaging and Labeling Operations for Crinetics products
Represent QA in internal and external team meetings
Support QA team on internal and external GMP audits
Performand/or reviewimpact assessmentsand risk assessments
Write and review Standard Operating Procedures
Write internal investigations, as applicable; review external, CMOinvestigations as assigned
Compile metrics of Batch Disposition, deviations, CAPAs, as applicable
Perform vendor audits as assigned and support vendor lifecycle activities
Other duties as assigned
Education andExperience:
Required:
Bachelor’s degree in chemistry,engineeringor other scientific discipline
7 years of relevant experience in aregulatedGMP environment with 2 years of supervisory/leadership experience
Demonstratedknowledge of FDA/EMA/ICH standards and regulations.
Demonstratedknowledge of Risk Assessment and Root Cause Analysis (5 WHYs, FMEA)
Relevant analytical experience, including understanding and working knowledge of chromatography and chromatographic methods (i.e.HPLC, GC)
Equipment:working knowledge of relevant manufacturing and analytical testing equipment and instrumentation
Demonstrateability to effectively organize,prioritizeand work in a fast-paced environment
Demonstrate ability to function individually and in a team environment
Software Knowledge: MS Office, ERP systems
Preferred:
Soliddosageor drug substanceexperience is preferred, however, experience in other dosage forms with relevant experience is acceptable
Prior experience with Electronic QMS systems (Veeva preferred)
Physical Demands and Work Environment:
Physical Activities:Ona continuous basis, sit atdeskfora long periodof time;intermittently answertelephoneand write or use a keyboard to communicate throughwritten means. Somewalking andliftingupto 25lbs.maybe.The noise level inthe work environment istypically lowto moderate.The physical demands describedabove are representative of those that must be met by an employee to successfullyperform the essential functions andresponsibilities of this job.Reasonableaccommodations may be made to enable individualswith disabilities to perform theessential functions and responsibilities.
Laboratory Activities(if applicable):Biology and chemical laboratory environmentexperience needed.Environmental health and safety requirements also apply.
Travel:
You maybe requiredto travel for up to 5% of your time.
The AnticipatedBase Salary Range:
In addition to your base pay, our total rewards program consists of a discretionaryannualtargetbonus,stock options, ESPP, and 401k match.We also provide top-notch health insurance plans for employees (and their families) to include medical, dental,vision and basic lifeinsurance,20 daysof PTO, 10 paid holidays, and awinter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length ofexperienceandeducation. Crinetics Pharmaceuticals is a multi-stateemployer,and this salary range may not reflect positions that work in other states.Your recruiter can share more about the specific salary range during the hiring process.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer.We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary Range
The salary range for this position is: $116,000 - $145,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
Apply Now
Apply Now