Job Description
The Director of CMC Project Management will provide critical support activities to multiple fast-moving late-stage development/commercialization programs. The major activities include establishing and refining business practices within CMC development, planning of project scope, timelines and budget, tracking of execution, facilitating communications within the team and externally, escalation of issues and knowledge management. There are regular interactions with external manufacturing sites, and with multiple service providers, suppliers and consultants. The position requires working knowledge of small and large molecules, analytical development and cGMP manufacturing workflows and practices. Successful candidate shall be an experienced technical project manager with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.
Responsibilities include, but not limited to:
- Provide project management and leadership contribution to the CMC development function within the company, with ownership responsibility for all aspects of CMC development for multiple clinical late stage programs and commercial products.
- Responsible for planning, coordinating and managing the activities of CMC development projects working closely with process, analytical, supply chain, regulatory and quality disciplines.
- Perform project scope, budget and timeline assessments, scenario planning, sensitivity analysis, and the set up and tracking of projects.
- Serve as project manager on cross functional project teams; communicate and collaborate with members from CMC, manufacturing, QC, QA, Regulatory Affairs, Clinical Development to achieve project goals and timelines.
- Partner with CMC team members to ensure timely, efficient and effective communications and adequate progress on team activities to achieve project goals. Proactively identify and communicate issues, risks and mitigation plans to broader team and management. Conduct and communicate lessons learned to improve on CMC processes.
- Provide meeting facilitation and documentation (agendas, documenting minutes, decisions, and action items).
- Establish and refine business practices, including use of analytics and metrics to enhance efficiency and drive continuous improvement, implement use of tools and best practices, process mapping and refinement of workflows, prioritization, triaging of issues.
- Organize project information using best practices and tools. Document decisions and lessons learned. Champion knowledge management culture within the CMC group.
Minimum Skills/Knowledge Required:
- D., M.Sc. or B.Sc degree in Biotechnology or other relevant life science discipline with at least 12 years’ relevant industry experience, with at least 5 years’ experience in a project management role.
- Experience participating in and leading cross functional teams.
- Experience interfacing with internal operations groups and/or contract manufacturing organizations.
- Demonstrated ability to apply and establish best practices of project management.
- Knowledge and broad understanding of the CMC approaches, including cGMP operations requirements and relevant regulatory guidelines.
- Excellent written and verbal communication skills.
- Ability to work in a fast-paced environment, to multitask and manage multiple projects.
- Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement.
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
EOE
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
About Eiger BioPharmaceuticals, Inc.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Please submit your resume to:
Position Overview
As one of the first colleagues to join the Eiger Medical Affairs field team, you will serve as a founding member of an expanding group that will be critical to the company’s future success. Our MSL field team will be responsible for helping to create and shape the foundation of Eiger’s Medical Affairs initiatives which will include the introduction of our company and our late-stage development programs, with a primary focus on HDV, building a key opinion leader network, developing and maintaining professional relationships with allied healthcare personnel and all external customers, and providing comprehensive medical and scientific support aligned to Eiger development and post approval initiatives. You will work collaboratively with the entire Eiger organization across all functional areas to ensure accurate and appropriate dissemination of information related to our pipeline and therapeutic areas critical to achievement of corporate objectives.
Responsibilities include, but not limited to:
- Develop and maintain scientific and medical expertise in disease states of strategic importance to the Eiger pipeline and corporate objectives;
- Identify, develop, and maintain peer-to-peer relationships with current and future Key Opinion Leaders (KOLs), Investigators, Allied Health Personnel;
- Deliver clinical presentations, product presentations, and information in response to clinicians, investigators and sites, academic settings, community and healthcare provider settings, payors;
- Report learnings and key insights from the field back into the Eiger medical team and broader organization when appropriate to support competitive awareness;
- Support Eiger clinical development activities, including site interaction when necessary, to facilitate ongoing or planned development initiatives, including patient enrollment;
- Develop and execute field regional plans in alignment with corporate strategic objectives and plans;
- Support the development, implementation, and execution of medical strategies and tactics (e.g. convention activities, advisory boards, congress symposia, regional KOL plans, and speaker programs) in close coordination with corporate objectives and plans.
Minimum Skills/Knowledge Required:
- Completed Pharm D, MD, PhD, MS in a scientific discipline preferred
- 5+ years of total pharmaceutical industry experience preferred
- 5+ years of post-professional degree practice or relevant experience (clinical practice, academic research, clinical operations, medical affairs) preferred
- Experience in literature review, analysis, and medical writing
- Hands on mentality & team-player
- Experience in Hepatology, Gastroenterology, and or rare diseases preferred
- Self-motivated, self-reliant, and able to work independently
- Knowledge of legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals
- Ability to effectively partner and maintain relationships with external stakeholders
- Ability to work cross functionally
- Excellent communication skills
- Ability to travel up to 50-60% of the time is a must
Title(s): Flexible, to be developed based on experience and fit within broader organization plan.
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
EOE
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
About Eiger BioPharmaceuticals, Inc.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Please submit your resume to:
Job Description
The Senior Director of Chemical Development will provide critical support activities to multiple fast-moving late-stage development and commercial programs. The major activities include the development and supply recombinant proteins from late stage through commercialization and management of current operations for resupply of small molecules and spray dried intermediates for approved oral products. The position requires a skilled leader able to influence projects and seamlessly integrate biopharmaceutical development activities across cross-functional project teams and global CROs. In addition to chemical engineering subject matter expert, should also have experience in analytical development and cGMP manufacturing workflows and practices. Successful candidate shall be an experienced technical project manager with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.
Responsibilities include, but not limited to:
- Lead the biopharmaceutical development efforts for a broad range of projects at different stages of development from late stage through global commercialization.
- Develop robust and scalable upstream and downstream processes for the expression, harvesting and purification of recombinant proteins.
- Design experimentation aimed at devising and optimizing safe, economical and scalable processes for the synthesis, isolation and purification of APIs and to support quality, throughput and yield improvements.
- Prepare multi-kilogram quantities of API and devise supply chain strategies to meet market forecasts.
- Participate in process scale-up decisions with manufacturing contractors, provide data and scientific rationale related to scalability of processes.
- Review and approval technical reports and documents for technology transfer packages and assist in the transfer of chemical processes to scale-up facilities.
- SME for assembly of regulatory updates and marketing applications.
Minimum Skills/Knowledge Required:
- PhD in Biological sciences or Biochemical Engineering with a minimum of 12 years industry experience or a BS/MS with a minimum of 15 years experience
- Hands on experience with process development and scale-up for clinical manufacture including the manufacture of products according to cGMP
- Strong knowledge of analytical techniques and control principles for biologics development and manufacture
- Direct experience of effectively managing development activities at external CROs
- Strong knowledge of regulatory requirements in ICH, US and EU
- Direct experience at preparing and reviewing CMC documentation for regulatory submissions and responding to regulatory questions
- Knowledge and experience of Statistically Designed Experiments and Quality by Design
- Ability to work in a fast-paced environment, to multitask and manage multiple projects.
- Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
EOE
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
About Eiger BioPharmaceuticals, Inc.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Please submit your resume to:
Job Description
The Senior Director of Product Development will be responsible for all aspects of formulation and process development from DOEs, process development, technology transfer/scale up and process validations for drug products, devices and commercial manufacturing. The Senior Director will also serve as CMC Lead of Eiger products and projects with the responsibility of authorship of the CMC sections of global regulatory submissions for both clinical and to be marketed products. This role is a broad-based, strategic position requiring an established leader with in-depth scientific and technical knowledge of biological product development.
Responsibilities include, but not limited to:
- Provide strategic oversight on product development activities including formulation, process development, process characterization, scale-up, technology transfer and process validation
- Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions.
- Serve as SME and participate in strategy guidance for CMC related regulatory interactions
- Collaborate effectively with Quality to ensure compliance with GMP guidelines at all times and make recommendations to ensure conformity with quality specifications.
- Oversee and manage process characterization and process validation studies, as well as technology transfer for all phases of development and commercial products.
- Manage external CMO activities, ensuring close partnership through open and transparent communications, scientific and strategic understanding, and attention to Eiger priorities
- Apply sound scientific and engineering criteria to design and develop manufacturing processes, identify and execute process improvement / optimization strategies, and ensure successful commercial scale-up for all programs
- Lead CMC projects and represent CMC in Project Development meetings, as required
- Develop resourcing strategies, allocate budget for department to meet company objectives and efficient operations
- Author of and/or reviews batch records, change controls, process validation and other technical documents.
Minimum Skills/Knowledge Required:
- D., M.Sc. or B.Sc degree in Biotechnology or other relevant life science discipline with at least 12 years’ relevant industry experience, with at least 5 years’ experience in a Product and Process Development role.
- Experience participating in and leading cross functional teams.
- Experience interfacing with internal operations groups and/or contract manufacturing organizations.
- Knowledge and broad understanding of the CMC approaches, including cGMP operations requirements and relevant regulatory guidelines.
- Excellent written and verbal communication skills.
- Ability to work in a fast-paced environment, to multitask and manage multiple projects.
- Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
EOE
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
About Eiger BioPharmaceuticals, Inc.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Please submit your resume to: