Sr. Specialist/Manager, CMC
Here at Tizona Therapeutics, we value Patients First!
With this goal in mind, Tizona develops next-generation immunotherapies.
The successful development of immunotherapies represents one of the most important and exciting breakthroughs in cancer. Despite the recent progress in the field of immuno-oncology, existing immunotherapies are only effective in a relatively small number of patients and types of cancer – a limitation that we hope to overcome.
Tizona’s therapies are designed to modulate the activity of immunosuppressive cells by targeting these cell types and the biological mechanisms responsible for immune suppression in the tumor microenvironment.
General Position Overview:
Tizona is experiencing a period of rapid growth and investment, and the Outsourcing group is currently seeking a Sr. Specialist/Manager to join the team. This person will work collaboratively with the various functional areas within Technical Operations and ensure smooth and efficient operational implementation of functional goals. This role will work closely with the Technical operations team to support various aspects of outsourced analytical testing, development and manufacturing of biologic products. They will be responsible for planning/tracking, contract establishment, work order/purchase order generation, timeline/deliverable monitoring, assist in project execution and document management. This is an excellent opportunity for a person with previous hands-on laboratory experience, that has transitioned into a business operations role supporting biologics.
Key Accountabilities/Core Job Responsibilities:
- Collaborates and establishes regular meetings with key stakeholders to ensure outsourced needs are met and activities are prioritized according to project needs.
- In collaboration with key stakeholders, assists in the execution and completion of project deliverables within agreed upon timeline and in compliance with legal contracts and agreements.
- Organizes and participates in teleconferences with CMOs and CTLs; works closely with Tizona teams to establish agenda and keep track of key decisions and action items.
- Obtains quotes, work orders from Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs) that conduct analytical, process development and manufacturing activities.
- Assists with establishment of legal and quality agreements, work orders and purchase orders in collaboration with internal Subject Matter Experts (SMEs) and Legal.
- Assists with evaluation and development of business tools and business processes to track work orders, and purchase orders.
- Provides logistical support for shipping of drug substance, drug product and samples both domestic and internationally.
- Provides support in developing and maintaining databases for tracking and trending of CMC related activities.
- Assists with document management and review of key technical operations deliverables and protocols.
Other Responsibilities Include:
- Maintains oversight of financials and project deliverables associated with outsourced development activities
- Monitors CMOs and CTLs communications, performance and project progress and provides timely updates to key stakeholders
- Proactively communicates issues, project changes to key stakeholders and facilitates timely discussion and resolution
Education and Experience Requirements:
- 6+ years of experience in a pharmaceutical/biotech organization or relevant manufacturing environment and a BA or BS degree; an MA/MBA degree may be considered as 2 years of relevant experience
- Prior experience working with outsourced development and manufacturing of biologics is desirable
- Strong computer skills and experience with project management software are essential
- Basic understanding of activities related to the CMC development of biopharmaceuticals is desirable
- Basic knowledge of GMPs and associated regulations is required
- Ability to collaborate with cross functional teams is required
- Strong negotiation, verbal and written communication skills are required
- Ability to manage multiple programs/projects; sound organizational and time management skills is essential
- Ability to work under uncertainty and to resolve conflict in a constructive manner
- Ability to solve moderately complex problems through ingenuity and collaboration with SMEs and other key stakeholders
- Ability to work in a fast-paced environment is required
Tizona Therapeutics is an Equal Opportunity Employer. We value diversity and are committed to providing employees a workplace free of discrimination and harassment. All employment decisions are based on qualifications, merit and business needs.