Job Summary
- Company
- Celgene Corporation
- Location
- Summit, NJ 07901
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- 13000467
About the Job
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Position Summary:
This position provides strategic and technical leadership to analytical development scientists and technical staff responsible for analytical characterizations, method development, validation, release and stability testing/reporting and specification development to support pharmaceutical small molecule drug substance and drug product manufacturing process and product development. The scope of responsibility spans discovery candidate lead optimization and continuing through pre-clinical, clinical, commercial and life-cycle development programs.
As a member of the Pharmaceutical Development Leadership Team, this position will work collaboratively with the other pharmaceutical development functions and Pharmaceutical Development Compound Leaders and contribute extensively to cross-functional program strategy, product development plans, timelines and oversight of the compound teams executing those plans. The position has global reach with responsibility for collaborations with internal stakeholders, external research partners and third party service providers.
Responsibilities include, but are not limited to, the following:
• Leads the overall scientific, technical and operational efforts of the Analytical Development department with analytical characterization, development/validation of analytical methods, specification development, release and stability testing and technology transfers to enable small molecule drug substance and drug product manufacturing process and product development to meet global clinical development needs.
• Leads a high-performing scientific and technical team of analytical scientists and technical staff who are cross-functionally aligned with Pharmaceutical Development strategies and priorities.
• Direct and manage the overall analytical development capabilities globally at Celgene including internal staff, internal facilities/equipment as well as outsourced resources.
• Work in collaboration with development and manufacturing colleagues to implement analytical controls, and support manufacturing and testing at CROs.
• Sets a high compliance standard and ensures that systems and resources are in place to ensure the activities of the laboratories are conducted in compliance with cGMP/GLPs, SOPs, good documentation practices, DEA regulations and OSHA safety standards and in accordance with corporate requirements. Ensures overall laboratory readiness for regulatory inspections (e.g., FDA, EMA and DEA) and internal audits.
• Reviews and ensures the delivery of high quality-related sections in CMC sections of IND/CTA/NDA filings for Celgene NCEs. Addresses inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
• Serves as a key strategic member of the Pharmaceutical Development leadership team by continually assessing functional capabilities and processes and provides guidance for best practices and direction for continuous improvement.
• Provides input to the development of program strategy, budgets, timelines, and product development plans. Helps ensure that scientific and business expectations are met.
• In cooperation with Compound Leaders, lead analytical science capabilities to enable the product and process development activities for compounds to ensure individual development candidates are advanced to meet global project requirements and corporate objectives.
• Apply scientifically-driven thinking and encourage the development of scientifically sound, well understood and robust manufacturing processes during the development and scale-up phases.
• Leverage scientific and pharmaceutical development knowledge and cross-functional experience to drive collaboration, interpretation of data to inform decision-making and value to Celgene.
• Ensures the department works as a productive development partner with collaborators and teams; facilitates the generation of and interpretation of data, and the development of product and process knowledge to contribute to team and company goals.
• Builds and maintains strong working relationships with colleagues in Research and Development, Regulatory CMC, Quality, and Technical Operations as well as alliance partner counterparts, as applicable.
• Collaborates with Discovery, Non-Clinical, Drug Substance and Drug Product Development groups to define drug candidate physico-chemical and quality attributes, testing methods, stability profiles, product performance characteristics, and specifications
• Provides committed and inspiring leadership, stewardship and advocacy, striving for scientific understanding, process knowledge development, continuous improvement, acceleration, risk assessment and mitigation, resource allocation and support, as appropriate
• Participation in due diligence assessment of potential business development interests, with ultimate responsibility for ensuring attention to small molecule analytical considerations.
• Create an environment that attracts, develops, retains and promotes diverse scientific, technical and management talent
• Direct management of personnel including performance appraisals, promotions, salary administration, staff hiring, mentoring, and other personnel related activities
• Planning and management of departmental operating and capital budgets for internal and external expenses, and resources to accomplish these responsibilities and objectives on an ongoing basis
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Qualifications
Prerequisites:
Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry or related scientific discipline. 15 + years experience in the pharmaceutical industry with increasing scientific and leadership responsibilities in analytical development.
Skills/Knowledge Required:
• Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry or related scientific discipline. 15 + years experience in the pharmaceutical industry with increasing scientific and leadership responsibilities in analytical development• Demonstrated scientific knowledge and experience in analytical science /organic chemistry in drug development and associated analytical requirements throughout the discovery/development/commercial continuum
• Demonstrated knowledge and expertise in analytical development of small molecule drug candidates, validation, specifications development and regulatory expectations
• Broad knowledge of the pharmaceutical development and commercialization process
• Established knowledge of applicable global drug development and regulatory standards
• Knowledge of cGMPs/GLPs, DEA regulations, ICH, FDA CMC Guidance Documents
• Experience with CMC technical sections of regulatory submissions and interacting with regulatory authorities on technical matters
• Experience in technology transfer of test methods to internal manufacturing sites and external CMOs
• Strong analytical and strategic thinking
• Demonstrated scientific and problem solving capabilities and cross functional understanding
• Experience in budget planning and oversight
• Excellent communication skills (oral, written, presentation)
• Demonstrated experience managing technical professionals including PhD staff, with a track record of fostering staff development
• Demonstrated skills building and maintaining productive relationships with organizational counterparts such as Discovery, Toxicology, Drug Substance Development, Drug Product Development, Technical Operations, Quality, and Regulatory CMC
• Excellent at negotiating, influencing and managing partner and contractor relationships.
• Demonstrated situational leadership skills (e.g. teambuilding, facilitation, conflict resolution, persuasion, negotiation)
*LI-PM1
Req ID: 13000467
Primary Location: United States-New Jersey-Summit
Job: Quality
Organization: Celgene Corporation
Schedule: Regular
Shift: Standard
Employee Status: Executive
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 10 % of the Time
Job Posting: 2013-11-18 00:00:00.0
Position Summary:
This position provides strategic and technical leadership to analytical development scientists and technical staff responsible for analytical characterizations, method development, validation, release and stability testing/reporting and specification development to support pharmaceutical small molecule drug substance and drug product manufacturing process and product development. The scope of responsibility spans discovery candidate lead optimization and continuing through pre-clinical, clinical, commercial and life-cycle development programs.
As a member of the Pharmaceutical Development Leadership Team, this position will work collaboratively with the other pharmaceutical development functions and Pharmaceutical Development Compound Leaders and contribute extensively to cross-functional program strategy, product development plans, timelines and oversight of the compound teams executing those plans. The position has global reach with responsibility for collaborations with internal stakeholders, external research partners and third party service providers.
Responsibilities include, but are not limited to, the following:
• Leads the overall scientific, technical and operational efforts of the Analytical Development department with analytical characterization, development/validation of analytical methods, specification development, release and stability testing and technology transfers to enable small molecule drug substance and drug product manufacturing process and product development to meet global clinical development needs.
• Leads a high-performing scientific and technical team of analytical scientists and technical staff who are cross-functionally aligned with Pharmaceutical Development strategies and priorities.
• Direct and manage the overall analytical development capabilities globally at Celgene including internal staff, internal facilities/equipment as well as outsourced resources.
• Work in collaboration with development and manufacturing colleagues to implement analytical controls, and support manufacturing and testing at CROs.
• Sets a high compliance standard and ensures that systems and resources are in place to ensure the activities of the laboratories are conducted in compliance with cGMP/GLPs, SOPs, good documentation practices, DEA regulations and OSHA safety standards and in accordance with corporate requirements. Ensures overall laboratory readiness for regulatory inspections (e.g., FDA, EMA and DEA) and internal audits.
• Reviews and ensures the delivery of high quality-related sections in CMC sections of IND/CTA/NDA filings for Celgene NCEs. Addresses inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
• Serves as a key strategic member of the Pharmaceutical Development leadership team by continually assessing functional capabilities and processes and provides guidance for best practices and direction for continuous improvement.
• Provides input to the development of program strategy, budgets, timelines, and product development plans. Helps ensure that scientific and business expectations are met.
• In cooperation with Compound Leaders, lead analytical science capabilities to enable the product and process development activities for compounds to ensure individual development candidates are advanced to meet global project requirements and corporate objectives.
• Apply scientifically-driven thinking and encourage the development of scientifically sound, well understood and robust manufacturing processes during the development and scale-up phases.
• Leverage scientific and pharmaceutical development knowledge and cross-functional experience to drive collaboration, interpretation of data to inform decision-making and value to Celgene.
• Ensures the department works as a productive development partner with collaborators and teams; facilitates the generation of and interpretation of data, and the development of product and process knowledge to contribute to team and company goals.
• Builds and maintains strong working relationships with colleagues in Research and Development, Regulatory CMC, Quality, and Technical Operations as well as alliance partner counterparts, as applicable.
• Collaborates with Discovery, Non-Clinical, Drug Substance and Drug Product Development groups to define drug candidate physico-chemical and quality attributes, testing methods, stability profiles, product performance characteristics, and specifications
• Provides committed and inspiring leadership, stewardship and advocacy, striving for scientific understanding, process knowledge development, continuous improvement, acceleration, risk assessment and mitigation, resource allocation and support, as appropriate
• Participation in due diligence assessment of potential business development interests, with ultimate responsibility for ensuring attention to small molecule analytical considerations.
• Create an environment that attracts, develops, retains and promotes diverse scientific, technical and management talent
• Direct management of personnel including performance appraisals, promotions, salary administration, staff hiring, mentoring, and other personnel related activities
• Planning and management of departmental operating and capital budgets for internal and external expenses, and resources to accomplish these responsibilities and objectives on an ongoing basis
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Qualifications
Prerequisites:
Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry or related scientific discipline. 15 + years experience in the pharmaceutical industry with increasing scientific and leadership responsibilities in analytical development.
Skills/Knowledge Required:
• Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry or related scientific discipline. 15 + years experience in the pharmaceutical industry with increasing scientific and leadership responsibilities in analytical development• Demonstrated scientific knowledge and experience in analytical science /organic chemistry in drug development and associated analytical requirements throughout the discovery/development/commercial continuum
• Demonstrated knowledge and expertise in analytical development of small molecule drug candidates, validation, specifications development and regulatory expectations
• Broad knowledge of the pharmaceutical development and commercialization process
• Established knowledge of applicable global drug development and regulatory standards
• Knowledge of cGMPs/GLPs, DEA regulations, ICH, FDA CMC Guidance Documents
• Experience with CMC technical sections of regulatory submissions and interacting with regulatory authorities on technical matters
• Experience in technology transfer of test methods to internal manufacturing sites and external CMOs
• Strong analytical and strategic thinking
• Demonstrated scientific and problem solving capabilities and cross functional understanding
• Experience in budget planning and oversight
• Excellent communication skills (oral, written, presentation)
• Demonstrated experience managing technical professionals including PhD staff, with a track record of fostering staff development
• Demonstrated skills building and maintaining productive relationships with organizational counterparts such as Discovery, Toxicology, Drug Substance Development, Drug Product Development, Technical Operations, Quality, and Regulatory CMC
• Excellent at negotiating, influencing and managing partner and contractor relationships.
• Demonstrated situational leadership skills (e.g. teambuilding, facilitation, conflict resolution, persuasion, negotiation)
*LI-PM1
Req ID: 13000467
Primary Location: United States-New Jersey-Summit
Job: Quality
Organization: Celgene Corporation
Schedule: Regular
Shift: Standard
Employee Status: Executive
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 10 % of the Time
Job Posting: 2013-11-18 00:00:00.0
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