AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

SUMMARY:

The Product Quality Lead (PQL) a full-time position located at the AGC Biologics facility located in Boulder, Colorado. The primary focus for this role is to provide technical expertise and project leadership to the Quality organization and to engage as a product quality expert with Core Teams, Manufacturing, Quality Control, MSAT, Regulatory, and other departments for a variety of activities with one or more products. The PQL will act as main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross-functional teams supporting the product lifecycle for both internal and external customers. Additionally, the PQL will act as the point of contact for major and critical investigations, ensuring all reports performed are scientifically sound and well written. The ideal candidate will possess a scientific background to help in the resolution of issues associated to the Manufacturing or any other critical process at AGC Biologics.

KEY RESPONSIBILITIES:

• Provides cross-functional quality leadership and supports program deliverables for one or more products/molecules and associated on-going life-cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers for the site.
• Provides quality perspective, expertise, and decisions as Quality representative on product cross-functional teams.
• Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations.
• Acts as the Customer point of contact for quality oversight for one or more products at different stages of the product lifecycle
• Provides guidance and Quality input to GMP decision making for day-to-day operations.
• Recognizes key product quality risks and ensures timely escalation of the identified risks to the right levels of the organization.
• Lead Quality Core Team meetings, provides metrics and discusses agenda topics with clients.
• Provides technical expertise and recommendations relating to product quality and influences solutions.
• Review and approval of product related deviations, change controls, CAPA and product specific GMP documentation (protocol, report, technical memo).
• Exercises independent judgment in interpreting and applying regulations to GMP systems. May make recommendations for QA policies and procedures. Interprets complex regulations and guidelines critical for advancing and improving the QA systems.
• Leads efforts to identify and implement processes and procedure optimization to facilitate compliance.
• Accountable for decisions and results that promote the efficiency of the processes at ACG and increase the customer satisfaction level with the internal and external clients.
• Supports science and risk-based evaluation of complex processes and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues.
• Contributes to the annual product review and may be a reviewer/approver.
• May lead projects or represent QA interests in multidisciplinary project teams. Works closely with other team members in a cooperative fashion to ensure project progression. May act as an advisor to multiple project teams.
• Responsible for making recommendations and decisions in accordance with federal and international regulatory requirements and industry standards.
• Ideally, but not strictly required, the candidate should possess scientific background and expertise in areas such as Quality Control (i.e. testing profiles and Laboratory Investigations) and be familiarized with the Manufacturing and Development processes.
• The candidate should be familiar with the Operational Excellence tools (i.e. Kaizen, Value Stream Mapping, etc.), basic Risk Management techniques and their applicability in the pharmaceutical industry.
  
  

KNOWLEDGE, SKILLS & ABILITIES:

• Experience working in a regulated environment (either direct GMP or technical role supporting GMP)
• Strong technical and analytical understanding of Biologics Manufacturing and testing.
• Demonstrated technical aptitude and experience with biologic drug tech transfers, analytical methods and commercialization.
• Expert knowledge of GMP and regulatory submission requirements.
• Knowledge in Operational Excellence and Risk Management.
• Demonstrated technical aptitude and experience with biologic drug tech transfers, analytical method transfer and product commercialization.
• Proven leadership ability to manage challenging decisions in a logical and compliance manner, with a demonstrated ability to influence team members in a cross-functional environment and effectively communicate with senior management.
• Must be self-motivated, organized, and proactive.
• Proven experience successfully managing multiple projects simultaneously.
• Demonstrated ability to build effective working relationships across departments (Manufacturing, QC, MSAT, Process Development, Project Management, and Business Development) to support new processes and products.
• Demonstrated experience leading troubleshooting efforts in regards to quality decisions.
• Strong communication skills necessary to interact with internal and external stakeholders.
• Strong presentation skills.

EDUCATION/EXPERIENCE:

• BA, BS or advanced degree in Life Sciences or Engineering required.
• Minimum of:
• Scientist I: 5+ years of experience in the biotechnology or pharma industry with experience in biologics with a BS/BA or 2+ years with a MS/MA
• Scientist II: 8+ years of experience in the biotechnology or pharma industry with experience in biologics with a BS/BA or 5+ years with a MS/MA
• Scientist III: 10+ years of experience in the biotechnology or pharma industry with experience in biologics with a BS/BA or 8+ years with a MS/MA
• Scientist Senior: 12+ years of experience in the biotechnology or pharma industry with experience in biologics with a BS/BA or 10+ years with a MS/MA
• Experience with client interfacing is preferred.
• Knowledge of cGMP and US & international filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals.
• Must have experience writing, reviewing, approving, and managing GMP documentation and quality system events. Direct QA experience is preferred.
• Equivalent education and experience may substitute for stated requirements.

COMPENSATION RANGE

$83,920 - $170,940

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.