BeiGene, Ltd.
Associate Director, DP Commercial Small Molecule
BeiGene, Ltd., Emeryville, California, United States, 94608
Associate Director, DP Commercial Small MoleculeBeiGene 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 Associate Director, DP Commercial Small Molecule in External Supply Quality organization is responsible for ensuring the commercial small molecule products are manufactured, packed, labelled, stored and transported in a controlled way at CMOs that is in accordance with the regulatory expectations and applicable GMP/GDP quality standards. The role has global responsibility and accountability for commercial product quality for global supply. The scope will also include product life cycle management projects like dosage form changes, packaging changes and clinical supply after commercialization.
The job holder will support and ensure the compliance to applicable international regulations and BeiGene quality standards and procedures at CMOs.
The job location would be in US so that close to where CMOs are based.
The scope of the role will include but not limited to the following:
Small molecule commercial products
For DP and FP stages at CMO
Managing quality issues and changes at CMOs
Post approval dosage form changes, packaging changes or other life cycle management projects, and clinical supply after commercialization
Essential Functions of the job:
Lead Small Molecule commercial product quality team to ensure the quality management process is in place and executed to ensure the product quality is compliant with regulatory requirements and BeiGene standards.
Perform batch record review
Lead batch related deviation handling in investigation and effective CAPA implementation at CMO
Manage change controls
Perform batch dispositions
Perform PIP (Person in Plant)
Prepare batch related documents e.g. COA
Manage temperature excursion from storage and transportation.
Ensure that quality processes meet Health Authorities expectation and continuously improve it by timely capturing related regulation changes.
Advise and support Quality Agreement content, implementation, and updates.
Obtain quality performance information at CMOs and drive continuous improvement. Provide the performance metrics information to CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed.
Closely collaborate with the CMO Vendor Management team on vendor performance monitoring and periodic review, support in audits as required.
Will work cross functionally and collaboratively in BeiGene with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU.
Provide quality support on product commercial supply e.g. timely batch release.
Support GCP inspections in IMP manufacturing perspective.
Execute product recalls from commercial supply chain when needed.
Perform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines.
Work with Clinical Product Quality, regulatory and CMC to establish Process Performance Qualification for Small Molecule products.
Author Standard Operating Procedures related to function and department.
Oversee the following investigations: nonconforming product, customer complaint, laboratory OOS and CAPA. Ensure all investigations are performed and closed in timely fashion.
Supervisory Responsibilities:
Responsible for management, development and co-ordination of a medium sized team of direct staff who are based in US.
Accountable for financial control and for the management of related budgets such as headcount related and travel.
Ensures sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
Build talent pipeline by inspiring and encouraging team members and create a great place to work for their personal development and career success.
Computer Skills:
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Qualifications:
Bachelor of Science degree or above, in a related scientific discipline/technical field such as Pharmacy, Biology, Chemistry or Engineering.
Minimum 8 years pharmaceutical or biotechnology industry experience.
8+ years of experience in quality with above 6 years management experience.
In-depth GMP experience in a quality and manufacturing function for small molecule oral solid dosage forms at DP and FP stages.
Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems. Ability to effectively lead teams and manage staff.
Travel:
May travel regionally and intercontinentally estimated up to 30%.
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
Salary Range: $134,400.00 - $184,400.00 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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General Description:
The Associate Director, DP Commercial Small Molecule in External Supply Quality organization is responsible for ensuring the commercial small molecule products are manufactured, packed, labelled, stored and transported in a controlled way at CMOs that is in accordance with the regulatory expectations and applicable GMP/GDP quality standards. The role has global responsibility and accountability for commercial product quality for global supply. The scope will also include product life cycle management projects like dosage form changes, packaging changes and clinical supply after commercialization.
The job holder will support and ensure the compliance to applicable international regulations and BeiGene quality standards and procedures at CMOs.
The job location would be in US so that close to where CMOs are based.
The scope of the role will include but not limited to the following:
Small molecule commercial products
For DP and FP stages at CMO
Managing quality issues and changes at CMOs
Post approval dosage form changes, packaging changes or other life cycle management projects, and clinical supply after commercialization
Essential Functions of the job:
Lead Small Molecule commercial product quality team to ensure the quality management process is in place and executed to ensure the product quality is compliant with regulatory requirements and BeiGene standards.
Perform batch record review
Lead batch related deviation handling in investigation and effective CAPA implementation at CMO
Manage change controls
Perform batch dispositions
Perform PIP (Person in Plant)
Prepare batch related documents e.g. COA
Manage temperature excursion from storage and transportation.
Ensure that quality processes meet Health Authorities expectation and continuously improve it by timely capturing related regulation changes.
Advise and support Quality Agreement content, implementation, and updates.
Obtain quality performance information at CMOs and drive continuous improvement. Provide the performance metrics information to CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed.
Closely collaborate with the CMO Vendor Management team on vendor performance monitoring and periodic review, support in audits as required.
Will work cross functionally and collaboratively in BeiGene with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU.
Provide quality support on product commercial supply e.g. timely batch release.
Support GCP inspections in IMP manufacturing perspective.
Execute product recalls from commercial supply chain when needed.
Perform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines.
Work with Clinical Product Quality, regulatory and CMC to establish Process Performance Qualification for Small Molecule products.
Author Standard Operating Procedures related to function and department.
Oversee the following investigations: nonconforming product, customer complaint, laboratory OOS and CAPA. Ensure all investigations are performed and closed in timely fashion.
Supervisory Responsibilities:
Responsible for management, development and co-ordination of a medium sized team of direct staff who are based in US.
Accountable for financial control and for the management of related budgets such as headcount related and travel.
Ensures sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
Build talent pipeline by inspiring and encouraging team members and create a great place to work for their personal development and career success.
Computer Skills:
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Qualifications:
Bachelor of Science degree or above, in a related scientific discipline/technical field such as Pharmacy, Biology, Chemistry or Engineering.
Minimum 8 years pharmaceutical or biotechnology industry experience.
8+ years of experience in quality with above 6 years management experience.
In-depth GMP experience in a quality and manufacturing function for small molecule oral solid dosage forms at DP and FP stages.
Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems. Ability to effectively lead teams and manage staff.
Travel:
May travel regionally and intercontinentally estimated up to 30%.
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
Salary Range: $134,400.00 - $184,400.00 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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