Manager, Clinical Supply Chain Job at Enanta Pharmaceuticals
Enanta Pharmaceuticals is seeking a self-motivated, experienced and talented candidate who thrives in a fast-paced, team-oriented environment. The candidate will join our growing supply chain team within CMC function. The individual will collaborate cross-functionally with the clinical/CMC teams and external vendors.
Primary Responsibilities: :
- Partner with Clinical Operations to identify clinical supply requirements and develop clinical supply plans for initial and subsequent packaging/labeling operations.
- Participate in internal and external cross-functional team meetings.
- Lead clinical supply meetings and develop dashboards for clinical and CMC teams.
- Manage CMO operations including but not limited to packaging, labeling, shipment, inventory management, global logistics, drug returns and destruction activities in accordance to Enanta’s deliverables and timelines. Request end of year cycle count.
- Lead and coordinate global label creation and review/approvals including: country requirements review/approval and label proof review/approvals.
- In conjunction with the Demand Planner manage IRT inventory stock levels and expiry dates at depots and clinical sites in order to bridge clinical supply requirements for forecasting and demand planning for all programs.
- Work with internal demand planner to monitor inventory levels at depots through the life of a trial to ensure supply and avoid stockouts.
- Collaborate with CMC and Demand Planner on production schedules to ensure timing of clinical drug product needs are met for all program deliverables.
- Participate in IRT set-up and UAT.
- Contribute to the development of systems and tools.
- Contribute to the development of the clinical supply business process and SOPs.
- Manage temperature excursion.
Other Duties and Responsibilities: :
- Participate in clinical supply system enhancement initiatives, as assigned and needed.
- Provide inventory reports as applicable.
- Provide dashboards, demand and forecasting reports as applicable.
- Other clinical supply activities as deemed necessary.
General Qualifications: :
- Collaboration & Teamwork:: Advanced competence in collaboration & teamwork, communications influence, strategic agility, planning & organizing, driving results, and problem solving.
- Productivity/Organizing/Planning: :Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Communication/Presentation Skills:: Excellent ability to convey both written and verbal information effectively and efficiently and present information to all levels of audiences.
- Willingness to Acknowledge Areas for Growth: :Understands need for growth and is receptive to constructive feedback.
- Leadership:: Strong ability to establish and communicate clear visioning that team members willingly follow; provide information, knowledge and methods to realize that vision; coordinate and balance conflicting internal and external interests; ability to influence decision-making in a diplomatic manner. Able to navigate team smoothly through difficult situations.
- Strategic Thinking:: Capable of thinking conceptually, imaginatively, systematically, and opportunistically to achieve company goals.
Education, prior work experience, and specialized skills and knowledge: :
- Bachelor’s degree or higher in life sciences
- 5+ years’ end to end clinical supply chain experience within Biotech and/or pharma industries.
- Experience in CMO management, including labeling, packaging, and distribution in North America and Europe.
- Experience with IRT system and implementation.
- Knowledge of cGMPs and relevant FDA and EU regulations and agencies.
- Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners.
- Strong analytical and organizational skills.
- Ability to negotiate and resolve conflicts.
- Ability to multi-task and work in a fast paced and dynamic environment.
- Microsoft proficient (Outlook, Excel, Word, PowerPoint and Project) Must have strong excel (formulas) knowledge.
- Travel domestic and international – up to 10%
Please complete the application below and include the following attachments:
- Cover Letter
- CV / Resume
- Research Summary (if applicable)
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta’s research and development programs include clinical candidates currently in development for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV).
Enanta’s research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.
Enanta Pharmaceuticals is an equal opportunity employer (EOE) with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, religious creed, gender, gender identity, sexual orientation, physical or mental disability, protected veteran status, or any other class protected by law.
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