A Clinical Stage Biotech is in a period of significant expansion and investment, and the Outsourcing group is looking for a Manager/Sr. Manager to join its ranks. This person will collaborate with the various functional areas within Technical Operations to ensure that functional goals are implemented smoothly and efficiently. This position will collaborate closely with the Technical Operations team to assist various elements of biologic product development, testing, and production. They will be in charge of planning/tracking, contract formation, work order/purchase order generation, timeline/deliverable monitoring, project execution assistance, and document management. This is a wonderful chance for someone who has previously worked in a hands-on laboratory and is now working in a business operations role supporting biologics.
- Plan and support stage-appropriate development of drug substance, drug product, and analytical methods
- Develop/author protocols and reports in collaboration with internal and external (CMOs). Work closely with an external CMO/CRO to guarantee that the project is completed correctly and on time.
- Assists in the execution and delivery of project deliverables within agreed-upon timelines and in accordance with legal contracts and agreements, in conjunction with key stakeholders.
- Contribute to the CMC portions of worldwide regulatory submissions. Assist in the maintenance of CMC documentation systems and, if needed, write development reports.
- Coordinates and participates in teleconferences with CMOs and CTLs; collaborates closely with Tizona teams to set the agenda and track key decisions and actions.
- Requests quotes and work orders from Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs) that do analytical, process development, and manufacturing tasks.
- Collaborates with internal Subject Matter Experts (SMEs) and Legal to produce legal and quality agreements, work orders, and purchase orders.
- Assists with the logistics of sending drug substances, drug products, and samples domestically and internationally.
- Assists with the creation and maintenance of databases for tracking and trending CMC-related activity.
Additional Responsibilities Include:
- Keeps track of the finances and project deliverables related with outsourced development.
- Keeps track of CMOs' and CTLs' communications, performance, and project progress, and communicates with important stakeholders on a regular basis.
- Communicates issues and project modifications to key stakeholders in a timely manner, allowing for timely discussion and resolution.
Education & Experience Requirements:
- BA or BS degree and 6+ years of relevant experience in a pharmaceutical/biotech firm or relevant manufacturing setting; an MA/MBA degree may be counted as 2 years of relevant experience.
- Prior experience in outsourced biologics development and manufacture is necessary.
- Knowledge of cGMPs and related requirements is essential.
- Strong computer skills and project management software experience are required.
- Knowledge of activities relating to biopharmaceutical CMC development is necessary
- The ability to work in cross-functional teams is essential.
- As needed, travel domestically or internally to meet project needs