Manager, Drug Supply Chain
San Diego, CA
Secura Bio is a newly established pharmaceutical company with an approved oncology therapeutic sold in the United States and in eighteen other countries.
The Manager, Drug Supply Chain will be a key contributor to Secura Bio’s clinical and commercial supply activities, to implement and maintain adequate systems for ensuring timely drug supply for clinical studies as well as commercial distribution. Responsibilities include contract vendors oversight, drug supply scheduling, documentation creation and review. The position will report to the Senior Director, Manufacturing, Regulatory & Quality.
Key Responsibilities Include:
- Develop drug supply planning strategy and overall management of supplies for clinical studies.
- Prepare demand-supply programs and translate into manufacturing and packaging schedules, in collaboration with commercial and clinical groups.
- Monitor and track global clinical supply inventory at the supply depots and clinical site level for studies; track specific milestone dates and adjust drug distribution plan accordingly.
- Manage and oversee distribution, shipping and import/export processes for product made in US and abroad.
- Coordinate drug supply delivery timelines with clinical operations, packaging contractor and with QA and Regulatory Affairs, as required.
- Interact and communicate with distribution partners to ensure activities are conducted successfully and according to timelines.
- Maintain close communications with internal groups to ensure the adequate supply of clinical supplies throughout the duration of multiple clinical trials.
- Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials.
- Coordinate the origination, proofing and translation of clinical study labels, as required.
- Monitor serialization processes and vendors in relation to DSCSA and FMD regulations.
- Establish plans and timelines, follow up on action items and identify solutions to typical situation in the supply chain of GMP pharmaceutical products.
- Participate of and support activities of the company’s quality system related to drug supply.
- Lead efforts and provide guidance to colleagues in the generation and revision of GMP documentation (e.g., procedures, specifications, etc.)
- Bachelor’s degree in a Life Sciences discipline or equivalent experience required.
- Minimum five (5) years of relevant experience in supply chain, manufacturing or equivalent CMC activities.
- Minimum of two (2) year of functional leadership experience.
- Thorough knowledge of cGMP regulations and good documentation practices.
- Thorough understanding of supply chain and CMC operations.
- Detail oriented with strong written and verbal communication skills.
- Proven ability to lead and manage projects and teams.
- Experience interacting with suppliers and senior staff.
- Strong organizational and analytical skills.
- Must have excellent customer service attitude.
- Ability to develop, recommend and implement procedures.
- Aptitude and motivation to learn and assume new responsibilities.
- Experience with Enterprise Resource Planning (ERP) systems is a plus.
- Prior experience with pharmaceutical contract manufacturing.
- Experience working in a start-up environment.
- Strong MS Office and presentation skills.
- Supervisory experience a plus.
Secura Bio offers competitive salaries and generous benefits.
If you meet the requirements for this position, please email us at firstname.lastname@example.org.