VitriVax, Inc.
Head of Clinical Manufacturing
VitriVax, Inc., Boulder, Colorado, United States, 80301
DescriptionThe Head of Clinical Manufacturing is responsible for designing, building and managing company resources for Clinical Manufacturing. The Head of Clinical Manufacturing must be a hands-on leader who can plan, execute, and help VitriVax staff successfully move Research ALTA products through GLP studies and early clinical development.
This position reports to the Head of CMC and is a member of the Senior Leadership Team. This is a full-time position, located in Boulder, Colorado.
Responsibilities and Duties:
Builds organizations and designs facilities that scale appropriately to support a growing portfolio of clinical candidates.
Hires, manages and leads staff responsible for aseptic manufacturing of early phase clinical drug products.
Establishes processes, procedures and equipment designs that are phase appropriate and consistent with annex 1 aseptic manufacturing expectations.
Prepares budgets, timelines and resource requirements for clinical manufacturing, equipment engineering and pilot plant operations.
Partners with Product Research and Development (PR&D) and Particle Engineering (PE) to efficiently move proof of concept product designs from Research to Clinical Development.
Authors all CMC sections of regulatory filings and represents VitriVax in regulatory meetings and audits.
Adheres to Company policies and safety guidelines.
Education and Experience:
10 years of experience in a pharmaceutical leadership role with significant GMP management responsibility and oversight of aseptic manufacturing is preferred.
In-depth knowledge of phase appropriate quality, FDA’s approach to risk management as well as the requirements and best practices for aseptic manufacturing.
Skilled at process transfer, risk assessment and IQ/OQ/PQ of aseptic manufacturing processes.
Documented experience managing diverse workforce in a GMP setting.
Sufficient subject matter expertise to constructively question process development data and offer suggestions to make manufacturing activities more cost/time effective.
Experience with biological molecules (proteins, lipids, and/or mRNA) is preferred.
Understanding of Quality by Design and ICH Q8, Q9, Q10, and Q11.
Core Skills and Competencies:All VitriVax employees are expected to share the following values:
Integrity:
We are team players who say what we do and do what we say. We respect our obligations and are transparent in our communication. We present all data factually. When presented with ambiguous situations, we strive to do the right thing.
Innovation:
We create value by developing superior products and processes. We have a curious mindset, apply an analytical approach and take calculated risks. We take on difficult problems and break barriers.
Passion:
We are passionate about making vaccines accessible to everyone. We share our enthusiasm with purpose. We are never satisfied with the status quo and want to make a difference.
Quality:
We seek quality information, decisions and people. We put safety first and approach every opportunity with a right first-time mindset that is focused on the end goal. We are committed to continuous improvement and elimination of waste.
Salary and Benefits:As written, the job description targets a Director level position. The position may be filled at the Associate Director or Director level depending on experience and fit with company needs. The level will be determined by the applicant’s experience and alignment with current and future responsibilities.
Director:
PhD or Operations MBA plus 10 years of experience aligned with VitriVax needs. Individuals with BS and 15 years of GMP management experience will be considered.
Associate Director:
PhD or Operations MBA plus 5 years of experience aligned with VitriVax needs. Individuals with BS and 10 years of GMP management experience will be considered.
Salary Range:
$150K to $220K DOE
All full-time employees are eligible for the following benefits:
Stock Options
401(k) with generous Company match
Flexible work schedule
Generous PTO
Health, Dental and Vision insurance
Short Term Disability insurance and Voluntary AD&D Insurance
VitriVax, Inc., is an Equal Opportunity Employer
and does not discriminate based on race, color, gender, sexual orientation, gender identity or expression, religion, disability, national origin, protected veteran status, age, or any other status protected by applicable national, federal, state, or local law.
VitriVax, Inc., requires all staff to be vaccinated against communicable diseases as recommended by the CDC prior to employment.
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This position reports to the Head of CMC and is a member of the Senior Leadership Team. This is a full-time position, located in Boulder, Colorado.
Responsibilities and Duties:
Builds organizations and designs facilities that scale appropriately to support a growing portfolio of clinical candidates.
Hires, manages and leads staff responsible for aseptic manufacturing of early phase clinical drug products.
Establishes processes, procedures and equipment designs that are phase appropriate and consistent with annex 1 aseptic manufacturing expectations.
Prepares budgets, timelines and resource requirements for clinical manufacturing, equipment engineering and pilot plant operations.
Partners with Product Research and Development (PR&D) and Particle Engineering (PE) to efficiently move proof of concept product designs from Research to Clinical Development.
Authors all CMC sections of regulatory filings and represents VitriVax in regulatory meetings and audits.
Adheres to Company policies and safety guidelines.
Education and Experience:
10 years of experience in a pharmaceutical leadership role with significant GMP management responsibility and oversight of aseptic manufacturing is preferred.
In-depth knowledge of phase appropriate quality, FDA’s approach to risk management as well as the requirements and best practices for aseptic manufacturing.
Skilled at process transfer, risk assessment and IQ/OQ/PQ of aseptic manufacturing processes.
Documented experience managing diverse workforce in a GMP setting.
Sufficient subject matter expertise to constructively question process development data and offer suggestions to make manufacturing activities more cost/time effective.
Experience with biological molecules (proteins, lipids, and/or mRNA) is preferred.
Understanding of Quality by Design and ICH Q8, Q9, Q10, and Q11.
Core Skills and Competencies:All VitriVax employees are expected to share the following values:
Integrity:
We are team players who say what we do and do what we say. We respect our obligations and are transparent in our communication. We present all data factually. When presented with ambiguous situations, we strive to do the right thing.
Innovation:
We create value by developing superior products and processes. We have a curious mindset, apply an analytical approach and take calculated risks. We take on difficult problems and break barriers.
Passion:
We are passionate about making vaccines accessible to everyone. We share our enthusiasm with purpose. We are never satisfied with the status quo and want to make a difference.
Quality:
We seek quality information, decisions and people. We put safety first and approach every opportunity with a right first-time mindset that is focused on the end goal. We are committed to continuous improvement and elimination of waste.
Salary and Benefits:As written, the job description targets a Director level position. The position may be filled at the Associate Director or Director level depending on experience and fit with company needs. The level will be determined by the applicant’s experience and alignment with current and future responsibilities.
Director:
PhD or Operations MBA plus 10 years of experience aligned with VitriVax needs. Individuals with BS and 15 years of GMP management experience will be considered.
Associate Director:
PhD or Operations MBA plus 5 years of experience aligned with VitriVax needs. Individuals with BS and 10 years of GMP management experience will be considered.
Salary Range:
$150K to $220K DOE
All full-time employees are eligible for the following benefits:
Stock Options
401(k) with generous Company match
Flexible work schedule
Generous PTO
Health, Dental and Vision insurance
Short Term Disability insurance and Voluntary AD&D Insurance
VitriVax, Inc., is an Equal Opportunity Employer
and does not discriminate based on race, color, gender, sexual orientation, gender identity or expression, religion, disability, national origin, protected veteran status, age, or any other status protected by applicable national, federal, state, or local law.
VitriVax, Inc., requires all staff to be vaccinated against communicable diseases as recommended by the CDC prior to employment.
#J-18808-Ljbffr