As an ideal candidate for this position, you should hold a Master's degree in Pharmacy with a specialization in Pharmacology or Pharmaceutical Analysis coupled with 5-8 years of experience. Alternatively, a Ph.D. with 2-5 years of relevant experience in PK/PD Modelling and PBPK models would also be considered. Your responsibilities in this role would include developing and applying pharmacometric models to aid in drug development and regulatory submissions. You must possess a deep understanding of non-linear mixed effects modelling and be proficient in using software tools such as PBPK models, Phoenix, R, PoPK, QSP modelling, or similar platforms. Your expertise in pharmacokinetics/pharmacodynamics (PK/PD) modelling and First-in-human dose predictions will be crucial for the success of this role. Collaboration is key in this position, as you will work closely with clinical pharmacology, biostatistics, and other interdisciplinary teams to shape clinical trial designs and analyze data. Your tasks will also involve creating and executing model-based strategies to enhance dosing regimens and achieve optimal therapeutic outcomes. Ensuring the accuracy and quality of pharmacometric analyses and reports will be a significant part of your role. You will be expected to engage with regulatory agencies, preparing submission documents related to pharmacometric analyses. Staying updated on the latest advancements in pharmacometrics and integrating new methodologies and technologies as needed will be essential. Additionally, presenting your findings and strategies to project team meetings and cross-functional teams is crucial, highlighting your ability to collaborate effectively in a team environment.,
As a candidate for the position, you should possess a M. Pharm (Pharmacology/ Pharmaceutical Analysis) or M.Sc. (Biochemistry/ Pharmaceutical Chemistry) degree with 11-14 years of experience or a Ph.D. with 2-5 years of experience in the fields of large molecule/ADC PK and bioanalysis. Your expertise should include Antibody Drug Conjugate characterization and bioanalysis, mass spectrometry-HRMS, Q-TOF, and Triple quad. Your role will involve being an expert in designing and executing DMPK studies to support antibody-drug conjugate (ADC) and monoclonal antibody (mAb) programs, ranging from discovery to IND-enabling stages. You should have extensive experience in quantifying biologics such as antibodies, therapeutic proteins, ADCs, and peptides using LC-MS/MS, MSD, and ELISA platforms. Proficiency in advanced bioinformatics tools like BioPharma Finder, MaxQuant, Spectronaut, and other relevant analytical software is essential. Your responsibilities will also include applying innovative techniques for identifying and selecting ADC and mAb lead candidates based on their functions, with a strong emphasis on DMPK profiling to ensure the safe and effective development of therapeutics. You should be adept at interpreting complex DMPK data and providing actionable insights to cross-functional project teams. Active representation of DMPK functions in internal and external meetings to promote collaboration and strategic alignment is crucial. Collaboration with cross-functional departments to address ADC-related challenges and provide integrated solutions from target validation to IND submission will be part of your role. You will be accountable for authoring and reviewing SOPs, study protocols, reports, and regulatory documentation to support both GLP and non-GLP studies. A strong foundational knowledge of DMPK principles including PK/PD, toxicology, and translational sciences is required. Demonstrated capabilities in communication, innovation, and team leadership will be essential for success in this position.,
As a highly skilled professional with a Ph.D. specializing in Immunology or Immuno-oncology and possessing 5-6 years of experience in academia and/or industry, you will be responsible for developing new cell therapy products. This includes conducting Process Development and validations to advance the product to the next stage. Your role will involve analyzing existing processes to identify areas for improvement, designing and developing new processes, and implementing them to enhance efficiency and productivity. Additionally, you will be tasked with scaling up the production process for seamless tech transfer to the GMP scientists. Your extensive experience in developing process documentation and training materials will be crucial, as you will be monitoring and tracking process performance to ensure compliance with regulatory and legal requirements. Your expertise will also be utilized in planning, implementing, and supervising process trials, as well as advising on equipment modifications for Process Improvement. A strong background in working with various immune cells and a deep understanding of both innate and adaptive immune systems are essential for this role. Preference will be given to candidates with previous experience in gene and/or cell therapy drug development teams. Proficiency in designing and delivering genes using viral or non-viral transfer techniques, as well as constructing viral vectors using advanced molecular synthesis and cloning techniques, is required. Familiarity with gene-editing tools such as CRISPR/Cas9 or TALEN is also necessary. Your expertise in molecular biology techniques like cloning, sub-cloning, real-time and quantitative PCR will be invaluable. You should be able to multitask and contribute to multiple projects under tight timelines while upholding integrity, accuracy, safety, and quality standards. Strong verbal, written, and presentation skills are essential, and previous experience in writing grants and research articles will be advantageous. The ideal candidate will have experience in team management or working in a cross-functional group and collaborating with clients. Leadership skills are a must to drive a team towards excellence, providing technical and scientific recommendations, troubleshooting effectively, and demonstrating innovative capabilities on a daily basis. Effective communication and collaboration within a highly matrixed team environment are vital to advance the company's cell therapy pipeline. Understanding sterile practices, work ethics, safety, health, and environmental regulations is crucial. You will be involved in compliance monitoring inspections, regulatory agency interactions, and the preparation and review of protocols, reports, and regulatory documents as per program requirements. Key competencies required for this role include expertise in cell therapy design and development, preparing and implementing quality compliant documentation, exceptional presentation and communication skills, effective team management, strong interpersonal skills, adept stakeholder management, and efficient vendor management.,
As an ideal candidate for this position, you should hold a Master's degree in Pharmacy with a specialization in Pharmacology or Pharmaceutical Analysis coupled with 5-8 years of experience. Alternatively, a Ph.D. with 2-5 years of relevant experience in PK/PD Modelling and PBPK models would also be considered. Your responsibilities in this role would include: - Developing and applying pharmacometric models to aid in drug development and regulatory submissions. - Possessing a deep understanding of non-linear mixed effects modelling. - Being proficient in using software tools such as PBPK models, Phoenix, R, PoPK, QSP modelling, or similar platforms. - Utilizing your expertise in pharmacokinetics/pharmacodynamics (PK/PD) modelling and First-in-human dose predictions. Collaboration is key in this position, as you will: - Work closely with clinical pharmacology, biostatistics, and other interdisciplinary teams to shape clinical trial designs and analyze data. - Create and execute model-based strategies to enhance dosing regimens and achieve optimal therapeutic outcomes. - Ensure the accuracy and quality of pharmacometric analyses and reports. You will be expected to: - Engage with regulatory agencies, preparing submission documents related to pharmacometric analyses. - Stay updated on the latest advancements in pharmacometrics and integrate new methodologies and technologies as needed. - Present your findings and strategies to project team meetings and cross-functional teams, showcasing your ability to collaborate effectively in a team environment.,
Role Overview: In this role, you will be responsible for developing new cell therapy products and performing validations to advance the product to the next stage. You should have extensive experience working with various types of immune cells and a deep understanding of both innate and adaptive immune systems. Previous experience in gene and/or cell therapy drug development teams would be beneficial. Your role will involve designing and delivering genes using viral or non-viral transfer techniques and constructing viral vectors using state-of-the-art molecular synthesis and cloning techniques. Additionally, you will utilize gene-editing tools such as CRISPR/Cas9 or TALEN and should be well-versed in molecular biology techniques like cloning, sub-cloning, real-time PCR, and quantitative PCR. Key Responsibilities: - Develop new cell therapy products and conduct validations for product advancement - Work with different immune cells and possess a strong understanding of innate and adaptive immune systems - Design and deliver genes using viral or non-viral transfer techniques - Construct viral vectors using advanced molecular synthesis and cloning techniques - Utilize gene-editing tools like CRISPR/Cas9 or TALEN - Perform various molecular biology techniques including cloning, sub-cloning, real-time PCR, and quantitative PCR - Manage multiple projects simultaneously under tight timelines while maintaining accuracy, safety, and quality - Demonstrate proficiency in verbal, written, and presentation skills - Previous experience in writing grants and research articles preferred - Manage a team or work in a cross-functional group and interact with clients/collaborators - Provide leadership to the team to ensure excellence and offer technical/scientific recommendations - Troubleshoot effectively and showcase innovative capabilities - Collaborate in a highly matrixed team environment to advance the company's cell therapy pipeline - Understand and adhere to sterile practices, work ethics, safety, health, and environmental regulations - Prepare for and participate in compliance monitoring inspections and regulatory agency interactions - Review and prepare protocols, reports, and regulatory documents as per program requirements Qualification Required: - Ph.D. in genetics with 2-3 years of relevant experience in Cell & Gene Therapy or - M.Sc./MTech in Biotechnology with 10-15 years of relevant experience in gene editing and immuno-oncology (Note: Any additional details of the company were not included in the provided job description.),
As an experienced individual with a background in M. Pharm (Pharmacology / Pharmaceutical Analysis) / M.Sc. (Biochemistry / Pharmaceutical Chemistry) with 11-14 years or Ph.D. with 2-5 years of relevant experience, you will be responsible for the following key roles and responsibilities: - Expertise in designing and executing DMPK studies to support antibody-drug conjugate (ADC) and monoclonal antibody (mAb) programs, covering the entire spectrum from discovery through IND-enabling stages. - Extensive experience in quantifying biologics such as antibodies, therapeutic proteins, ADCs, and peptides using platforms like LC-MS/MS, MSD, and ELISA. - Proficiency in utilizing advanced bioinformatics tools like BioPharma Finder, MaxQuant, Spectronaut, and other relevant analytical software. - Skill in applying innovative techniques for function-based identification and selection of ADC and mAb lead candidates, emphasizing DMPK profiling for safe and effective therapeutic development. - Interpretation of complex DMPK data and providing actionable insights to cross-functional project teams. - Active representation of DMPK functions in internal and external meetings, fostering collaboration and strategic alignment. - Close collaboration with cross-functional departments to address ADC-related challenges and provide integrated solutions from target validation to IND submission. - Accountability for authoring and reviewing SOPs, study protocols, reports, and regulatory documentation to support both GLP and non-GLP studies. - Strong foundational knowledge of DMPK principles, including PK/PD, toxicology, and translational sciences, with demonstrated capabilities in communication, innovation, and team leadership. If there are any additional details about the company provided in the job description, please kindly provide them for further insights into the organization.,
As a Scientist in Pharmaceutical Development, you will be responsible for planning and executing various tasks related to the development, scale up, and manufacturing of drug products for monoclonal antibodies (mAb), bi-specific, tri-specific antibodies, and Antibody Drug Conjugates (ADC) of New biological entities (NBE). Your key responsibilities will include: - Significant experience in development, scale up, and manufacturing of drug products for mAbs, ADCs, etc. - Experience in parenteral delivery systems development like Nanoparticulate delivery systems, Lipid based delivery systems. - Proficient in pre-formulation studies of mAbs and ADCs along with physiochemical & Solid-State characterization. - Proficiency in interpreting in silico output on mAb developability and strategically using it for experimentation. - Hands-on experience in preclinical formulation development of mAbs and ADCs. Qualifications required for this role include: - Proficiency in planning and executing preclinical formulation development of mAbs and ADCs. - Ability to plan and execute pre-formulation studies, stability studies, etc., for mAB and ADC projects. - Experience in formulation development of New biological entities from mAB and ADC platform for human clinical studies. - Proficiency in executing approaches and strategies for scale up, tech transfer of mAB and ADC drug products to manufacturing facilities. - Coordination and execution of drug products of mAB and ADC under GMP set up for clinical trials with appropriate documentation. - Support development of enabling formulations for improving the bio-pharmaceutical properties and bioavailability of New Chemical Entities (NCEs). In addition to the above, you will also contribute scientifically to overall pharmaceutical development processes, prepare protocols, guidelines, SOPs for lab equipment/instruments and processes, and adhere to systems and processes pertaining to safety, health, and the environment. If you are selected for this role, you will be expected to demonstrate competencies in Presentation & Communication Skills, Interpersonal Skills, Excel Skills, Scientific Report Writing, and Team Management.,