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:
Contract Manufacturing Site Managers work closely with contract manufacturers (CMOs) worldwide, Supply Chain leads, Quality and operations partners to ensure supply continuity with optimal cost and quality. Contract Manufacturing Site Managers also provide oversight of the production plans that will help drive the evolution and implementation of new platforms, systems and processes that enable greater operational efficiency, accuracy and utilization of the clinical product pipeline. In this role you will use your manufacturing experience and partner relationships to optimize the overall supply chain helping to achieve the ultimate goal of delivering BeiGene’s pipeline to patients.
Essential Functions of the job:
- Serve as the Sr. Contract Manufacturing Site Manager overseeing BeiGene’s global network (with specific focus on US/EU) of clinical contract manufacturing organizations (CMOs) supporting clinical drug labeling and packaging. Scope of work includes: management of drug from the release of Drug Product (DP) at the filling site through release of Final Packaged Goods (FG) at the label/pack site; scheduling and oversight of label/pack execution activities at the label/pack site; and ensuring the necessary DP materials and FG components are available for execution.
- Interact with senior internal and external leadership on significant issues and business meetings and relationships
- Participate on cross-functional teams in evaluating and selecting CMOs for a particular project as requested.
- Provide input to the internal CMO/partner SPOC ensuring that the overall relationship between Beigene and the CMO/partner is healthy.
- Drive continuous improvement of the business relationship.
- Participate in CMO Site visits as requested.
- Proactively manage the operational pack activities (schedule, timelines, etc.) of the CMO ensuring program cost, quality, metrics, delivery and technology objectives are met as well as manage the partner performance to achieve them. Proactively intercede if goals and timelines are jeopardized, communicating to appropriate stakeholders as needed.
- Identify any supply constraints and negotiate/resolve with the CMO any issues to meet the supply plan.
- Partner with key stakeholders in the preparation for Requests for Quotes (RFQs), Statements of Work (SOW) and negotiate supply agreements for clinical programs.
- Serve as the manufacturing outsourcing team leader on cross-functional teams as requested in support of clinical finished good packaging.
- Generate and distribute reports for overall site metrics, key issues, production status and highlights, and regular operational performance summary updates as required.
- Participate in Master Service Agreement creation and maintenance as requested so that it accurately reflects the existing business relationship.
- Support Global QA in establishing QA agreements with all CMOs and assuring that Product Specific Requirements (PSRs) are established before projects are initiated.
- Work independently, developing and leading process improvements for a variety of complex and advanced technical problems and initiatives for self as well as for department.
- Apply advanced technical expertise in solving and developing department initiatives and goals.
- Periodically report on performance and operations at internal and/or external Operations Reviews.
- Set personal performance goals and provide input to departmental objectives.
- Establish work priorities to meet targets and timelines.
- Collaborate and author department policies and procedures.
- Make decisions that impact the goals and objectives of the department.
- Notify Management of potential business issues that may affect project timelines.
Supervisory Responsibilities: None.
Education Required:
B.S. Degree, MBA or advanced degree a plus.
7+ years of experience in biotech/pharma industry. Packaging experience is beneficial (small molecule, biologic devices).
5+ years of relevant experience and a MA/MBA.
Protein or small molecule manufacturing experience is beneficial.
Competencies:
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, Project, PowerPoint and Outlook.
- Experience with an ERP system (SAP preferred).
Other Qualifications:
- Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and/or GCP).
- APICS certification a plus.
- Due to the global nature of the company early morning or evening meetings may be required.
- Experience in vendor oversight and managing external partnerships and relations.
- Familiarity with risk management tools (FMEA, etc).
- Demonstrated financial skills (i.e. developing and managing a budget, etc)
Travel: ~15%, domestic and international
Salary Range: $126,700.00 - $171,700.00 annually
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We 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.
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