Qa Supervisor - Labeling/Packaging

We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.

The Role

The Quality Assurance Supervisor will support the Agenus West Christie Ave (Emeryville) Labeling and Packaging operations, Clinical Labeling and Packaging operations (CMO/CRO), and the associated Quality Systems (Deviation, CAPA, Change Control etc.). The position will support the master batch record and SOP development for Labeling and Packaging operations, review of deviations and executed batch records, and disposition onsite and CMO labeled/packaged drug product. The Supervisor will report to the Associate Director, Quality Assurance, and partner with Global QA for Quality System initiatives, as directed.

In The Role You Will

• QA and GMP compliance for all aspects in support of clinical and commercial (future) operations
• Site Quality Systems Management: CAPA, Change Control, Deviations, Investigations, Risk Assessment, and Vendor Change Notification with emphasis on labeling/packaging operations
• Support internal, partner and health authority audits, as needed
• Site QA Representative with Agenus Corporate for Corporate QA SOPs development/revision, as directed
• Onsite and CMO finished (labeled/packaged) drug product lot batch record QA review and disposition.
• Support/review applicable regulatory submissions, as needed
• Quality Assurance Approver for site SOPs and other GMP documentation associated with labeling/packaging operations

Qualifications: About You

• Working knowledge of GMP principles with respect to FDA and EMA regulations
• Experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.)
• Experience with supervision and training of personnel preferred
• Minimum of 5 years in Quality Assurance, preferably in the biologics field
• Experience with labeling/packaging operations preferred
• Working knowledge and technical understanding of the manufacture and testing of biologics
• Experience working with contract manufacturing and testing facilities (domestic and global)

Education Requirements

• BS (or equivalent) in a scientific related field with a minimum of 7 years’ experience in the pharmaceutical/biotech industry

Agenus is delighted to provide you with a comprehensive benefits plan, including some of the following:

• Flexible Vacation Plan-In a time when we move at the speed of light, what matters most is what we achieve, not how many hours we clock or accrue. We want people to take breaks when they need them most and own their time. Our philosophy at Agenus is that freedom to take this time will lead to clarity, creativity and innovation through rested and refreshed eyes. With our Flexible Vacation Plan, Agenus will not limit the amount of vacation you can take. It will allow you to take the vacation time as you need, while fulfilling your job responsibilities and making meaningful contributions to our mission.
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Employee Stock Purchase Plans
• Care.com Memberships
• Highly competitive and inclusive medical, dental and vision coverage options
• Employee Assistance Program
• Free Parking
• Catered Lunch in our Lexington Location
• 401k match and Financial Planning tools
• Education Assistance Program

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

• Education Assistance Program
• Employee Assistance Program
• Catered Lunch
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 401k match and Financial Planning tools
• Flexible Vacation Plan-In a time when we move at the speed of light, what matters most is what we achieve, not how many hours we clock or accrue. We want people to take breaks when they need them most and own their time. Our philosophy at Agenus is that freedom to take this time will lead to clarity, creativity and innovation through rested and refreshed eyes. With our Flexible Vacation Plan, Agenus will not limit the amount of vacation you can take. It will allow you to take the vacation time as you need, while fulfilling your job responsibilities and making meaningful contributions to our mission
• Employee Stock Purchase Plans
• Care.com Memberships
• Free Parking
• Highly competitive and inclusive medical, dental and vision coverage options

Our core values

The way we work sets Agenus apart.

We put the patient first

We aspire to change the world, improving the experience and options available for every single cancer patient. The answers are out there, and patients are waiting.

We are bold, and we are one

We believe that the only way to deliver on our goals is to aim high and work as one global team. We look for opportunities to challenge, collaborate with, and support one another. We aim to break conventional standards and perform at extraordinary levels.

We work with integrity, respect and honesty

These three building blocks serve as pillars for how we behave, operate, and execute our mission.

We are a culture of ownership and accountability

We hold ourselves accountable not only for exceptional results, but how we get our results.

We are obsessively curious and deeply committed to learning

We live in a fast-paced environment that requires us to learn at or above the speed of change. We believe that curiosity fuels the desire to create, and learning provides the tools to progress.

We perform at our best every day

Every day counts. We confront insurmountable obstacles, problems and choices with intellect, perseverance and hard work.