Associate Director/Director, Quality Control (Analytical)

Boston, MA, United States

Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications. Associate Director/Director, Quality Control (Analytical) HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens. HIL-214 has been studied in eight Phase I/II studies in more than 4,500 subjects. HilleVax is currently planning initiation of a Ph 2b study in infants.

We are a rapidly growing and dynamic organization that is founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health. Our goal is to build a company that equalizes opportunity for people around the world by removing barriers of health inequity, and we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases.

Objectives / Overview:

The Associate Director/Director of Quality Control (Analytical) provides oversight of all external cGMP analytical testing. They will work in partnership with Technical Operations, Quality Assurance and external laboratories to assure that QC analytical testing is performed in compliance with applicable regulations, company quality standards and current industry practices. The responsibilities also include providing leadership for all QC testing to support vaccine manufacturing, identifying and mitigating product quality, safety, and regulatory compliance risks, as well as working to establish internal Quality Control processes.

Responsibilities:

Oversees the overall Quality Control analytical testing strategy

Ensures QC testing at external GMP laboratories meet applicable regulatory requirements

Ensures proper investigation into the root cause of product and/or process failures

Leads OOS investigations, deviations, CAPA and change controls

Provides support for all testing, tasks, and documentation in support of Validation Studies including Process Validation, Media Fills, Method Validation, and development of analytical methods

Drafts and reviews appropriate sections of Regulatory submissions

Interacts with agents from Regulatory agencies and participates in Audits and Inspections

Supports the preparation of dossiers and data packages for interactions between HilleVax and Regulatory agencies

Writes and proposes revisions to Standard Operating Procedures, Analytical Methods, Technical Reports, and related Forms.

Reviews and assesses proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate

Liaises with other departments to ensure business continuity including Quality, Manufacturing, MS&T, Supply Chain, and Regulatory

Education, Experience & Skills: Minimum of a bachelor’s degree in biological sciences; advanced degree in biological sciences desirable

A minimum of 8 years’ experience in a QC analytical testing laboratory

A minimum of 4 years’ experience in a management role

Experience with coordinating QC testing at external contract laboratories

Experience with aseptic manufacturing and biologics/vaccines

Expertise in microbiology, virology and environmental monitoring testing

Strong understanding of Quality Control testing requirements for pre-clinical, clinical, and commercial stage work.

Comprehensive knowledge of compliance with cGMP regulations

Highly skilled in root cause investigations, change control, and regulatory inspections

Able to handle multiple projects and exercise good judgment in prioritizing tasks

Excellent verbal, written and organization skills

Ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (vendors, investigators, regulatory authorities, and other stakeholders)

Location Remote-US East Coast preferred

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens. HIL-214 has been studied in eight Phase I/II studies in more than 4,500 subjects. HilleVax is currently planning initiation of a Ph 2b study in infants.

We are a rapidly growing and dynamic organization that is founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health. Our goal is to build a company that equalizes opportunity for people around the world by removing barriers of health inequity, and we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases.

Objectives / Overview:

The Associate Director/Director of Quality Control (Analytical) provides oversight of all external cGMP analytical testing. They will work in partnership with Technical Operations, Quality Assurance and external laboratories to assure that QC analytical testing is performed in compliance with applicable regulations, company quality standards and current industry practices. The responsibilities also include providing leadership for all QC testing to support vaccine manufacturing, identifying and mitigating product quality, safety, and regulatory compliance risks, as well as working to establish internal Quality Control processes.

Responsibilities:

Oversees the overall Quality Control analytical testing strategy

Ensures QC testing at external GMP laboratories meet applicable regulatory requirements

Ensures proper investigation into the root cause of product and/or process failures

Leads OOS investigations, deviations, CAPA and change controls

Provides support for all testing, tasks, and documentation in support of Validation Studies including Process Validation, Media Fills, Method Validation, and development of analytical methods

Drafts and reviews appropriate sections of Regulatory submissions

Interacts with agents from Regulatory agencies and participates in Audits and Inspections

Supports the preparation of dossiers and data packages for interactions between HilleVax and Regulatory agencies

Writes and proposes revisions to Standard Operating Procedures, Analytical Methods, Technical Reports, and related Forms.

Reviews and assesses proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate

Liaises with other departments to ensure business continuity including Quality, Manufacturing, MS&T, Supply Chain, and Regulatory

Education, Experience & Skills: Minimum of a bachelor’s degree in biological sciences; advanced degree in biological sciences desirable

A minimum of 8 years’ experience in a QC analytical testing laboratory

A minimum of 4 years’ experience in a management role

Experience with coordinating QC testing at external contract laboratories

Experience with aseptic manufacturing and biologics/vaccines

Expertise in microbiology, virology and environmental monitoring testing

Strong understanding of Quality Control testing requirements for pre-clinical, clinical, and commercial stage work.

Comprehensive knowledge of compliance with cGMP regulations

Highly skilled in root cause investigations, change control, and regulatory inspections

Able to handle multiple projects and exercise good judgment in prioritizing tasks

Excellent verbal, written and organization skills

Ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (vendors, investigators, regulatory authorities, and other stakeholders)

Location Remote-US East Coast preferred

Travel, Physical Demands & Work Environment: Willingness to travel (20-25%) to various meetings or third-party sites, including overnight trips.

Some international travel may be required.

HilleVax is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We welcome all to apply.

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