Senior Manager, Clinical Supply Chain
Company: BeiGene, Ltd.
Location: San Mateo
Posted on: January 20, 2023
BeiGene continues to grow at a rapid pace with challenging and
exciting opportunities for experienced professionals. When
considering candidates, we look for scientific and business
professionals who are highly motivated, collaborative, and most
importantly, share our passionate interest in fighting
cancer.General Description:The Sr Manager of Clinical Supply Chain
manages drug supply activities related to planning, label
development, label & pack, and distribution for one or more
clinical studies. - Actively develops and oversees supply plans to
ensure accurate and continuous supply to patients while reducing
risk and minimizing waste. - Represents Clinical Supply Chain to
internal stakeholders and manages relationships with external
supply partners. - Has a working knowledge of clinical supply best
practices, IRT systems, as well as experience working within a cGMP
environment. Works with management to develop and implement process
improvements to build the organization for the future.The Sr
Manager of Clinical Supply Chain leads staff and provides
leadership and guidance during process implementationsEssential
- Represent the Clinical Supply Chain on Clinical Study Teams
(CST) and provide a high service level to internal stakeholders
(e.g. Clinical Operations, Regulatory, Quality, CMC).
- Work with Clinical Operations to understand clinical demand
requirements and ensure alignment with study teams to supply plans
- Create supply and inventory plans and develop production
schedules for clinical trial materials.
- Monitor schedule adherence of production schedules and make
course corrections if needed.
- Manage GMP inventory throughout the supply chain, develop
inventory reports, manage upcoming expiry, and ensure drug
- Manage the relationship and oversee daily activities for FG
label & pack CMOs and distribution vendors.
- Responsible for investigation of exceptions to determine root
causes, implement CAPAs and drive closure.
- Ensure label text and proofs are in accordance with applicable
rules, regulations, product specifications, and clinical study
- Coordinate review and approval of labels with stakeholders
(e.g. Regulatory, Clinical Operations, CRO) and CMOs.
- Support IRT user acceptance testing, develop IRT supply
strategy (DNX parameters), and oversee ongoing supply activities in
- Coordinate and track bulk shipments to CMOs, depots, and
vendors. - Maintain and track import licenses.
- Develop supply strategies to maximize supply efficiency,
minimize waste while identifying risk and develop risk mitigation
- Lead cross functional projects and process improvements related
to drug supply.
- Assist in the creation of Standard Operating Procedures.
- Additional responsibilities as required.
- Leads staff who are in supportive roles for supply planning and
business process developmentCompetencies:
- Demonstrates knowledge of global clinical trials and the drug
- Experience in vendor oversight and managing external
partnerships and relations.
- Understands comprehensive global pharmaceutical regulatory
requirements (e.g. cGMP, GDP, and GCP).
- Experience in deviation investigation and CAPA
- Knowledge of IRT system setup and functionality and proficiency
with Excel modeling.
- Strong analytical, problem solving, and communication
- Strong collaboration and excellent team skills to be successful
in cross-functional and multi-cultural teams.Education Required:
Bachelor or Master Degree in Business Administration, Operations
Management, or similar education required.5-8 years progressive
experience in Supply Chain preferably within the biotech,
pharmaceutical, CRO, industry.Ethics - Treats people with respect;
Inspires the trust of others; Works with integrity and ethically;
Upholds organizational values.Planning/Organizing - Prioritizes and
plans work activities; Uses time efficiently. - Completes
administrative tasks correctly and on time. - Follows instructions
and responds to management direction.Communication - Listens and
gets clarification; Responds well to questions; Speaks clearly and
persuasively in positive or negative situations. - Writes clearly
and informatively. - Able to read and interpret written
information.Teamwork - Balances team and individual
responsibilities; Gives and welcomes feedback; Contributes to
building a positive team spirit; Puts success of team above own
interests; Supports everyone's efforts to succeed. - Contributes to
building a positive team spirit; Shares expertise with
others.Adaptability - Able to adapt to changes in the work
environment. - Manages competing demands. - Changes approach or
method to best fit the situation. - Able to deal with frequent
change, delays, or unexpected events.Technical Skills - Assesses
own strengths and development areas; Pursues training and
opportunities for growth; Strives to continuously build knowledge
and skills; Shares expertise with others.Dependability - Follows
instructions, responds to management direction; Takes
responsibility for own actions; Keeps commitments; Commits to long
hours of work when necessary to reach goals; Completes tasks on
time or notifies appropriate person with an alternate plan.Quality
- Demonstrates accuracy and thoroughness; Looks for ways to improve
and promote quality; Applies feedback to improve performance;
Monitors own work to ensure quality.Analytical - Synthesizes
complex or diverse information; Collects and researches data; Uses
intuition and experience to complement data.Problem Solving -
Identifies and resolves problems in a timely manner; Gathers and
analyzes information skillfully.Project Management - Communicates
changes and progress; Completes projects on time and
budget.Computer Skills : - -Efficient in Microsoft Word, Excel, and
OutlookWe are proud to be an equal opportunity employer and we
value diversity. BeiGene does not discriminate on the basis of
race, religion, color, sex, gender identity, sexual orientation,
age, disability, national origin, veteran status or any other basis
covered by appropriate law. All employment is decided on the basis
of qualifications, merit, and business need.
Keywords: BeiGene, Ltd., San Mateo , Senior Manager, Clinical Supply Chain, Professions , San Mateo, California
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