Fladger Associates

Author and finalize Module 3 documents and responses to agency questions supporting CMC regulatory submissions and process development teams. | 7+ years of biochemical engineering or related experience with CMC regulatory submission expertise, technical writing skills, and knowledge of biologics manufacturing and regulatory requirements. | Responsibilities: Excellent employment opportunity for a Technical Writer - III in the Santa Monica, CA area.Contractor Role JD: CMC TW/Technical RoleSeeking a highly motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience.This position is part of the Process Development organization and in this role, this individual will be supporting the internal Process Development teams.In the near-term, this role will support time critical CMC Regulatory submissions.Longer-term, this individual will be embedded in technical teams within the Process Development department supporting CMC aspects of our growing pipeline projects.Author and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter ExpertsExperience in analytical method development of vector and T cell, extended characterization of vector and T cell products, awareness of ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates.Experience:Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant experienceExperience CMC/Module 3 regulatory submissionsExperience in technical writing and proficient in high quality writingDemonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process developmentThorough knowledge of biologics analytical and process development is essential.Cell therapy process development experience is highly desiredKnowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturingWorking knowledge of regulatory requirements for biologics, pharmaceuticals and medical devicesMust be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisionsAbility to think critically, and demonstrated troubleshooting and problem solving skillsSelf-motivated and willing to accept temporary responsibilities outside of initial job descriptionWell-developed computer skills and fluent with Microsoft office applicationsExcellent interpersonal, verbal and written communication skills are essential in this collaborative work environmentComfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

Manage LMS training transactions, coordinate course delivery and logistics, generate reports, manage vendor partnerships, and support internal communications for Learning & Development. | 7+ years HR or related experience, BA/BS degree, strong communication and organizational skills, ability to manage multiple projects and vendors, and preferred experience in training administration. | Responsibilities: • Excellent employment opportunity for a Senior Learning & Development Specialist - III in the Foster City, CA area. • Executes HR-related training-related transactions in LMS including assignment of HRtraining modules, maintenance of training completions, e-learning testing, activityreporting, etc. • Supports classroom course delivery and logistics by coordinating and executing course enrollment, course scheduling, preparing course materials, equipment,facilities, etc. • Generates standard and ad-hoc reports in PeopleSoft and/or LMS. • Coordinates vendor partnerships including invoices, payments, and contracts. • Coordinates employee and manager marketing efforts as well as internalcommunications between Learning & Development, HRBPs, and other traininggroups. • Ensures Learning & Development courses are up-to-date and accurate in the LMS. • Administers 360 and Upward feedback assessments. • Manages external eLearning vendor, Brainshark, and ensures new users receivetraining and account set-up. • Participates in the on-going evolution of the Learning & Development organization interms of values, operations, and service delivery. • Contributes to HR projects providing status updates and process flow developments,knowledge transfer and training to the Learning & Development team. Experience: • Specific education and experience requirements: 7+ years of experience in Human Resources or related area and a BA/BS. • Must be able to perform job responsibilities and duties under minimal supervision. • Strong verbal, written, interpersonal and telephone communication skills are required. • Ability to interface effectively with all levels. • Effective team-working skills. • Must have strong organization and time management skills and be able to managemultiple projects and/or tasks simultaneously. • Possess a strong customer service orientation while maintaining a high level ofintegrity and confidentially with each interaction. • Independently understand, follow and implement complex instructions. • Ability to use good judgment in making decisions. • Ability to oversee the work of vendors, contractors, and temporary employees. • Experience in training administration is preferred.

Coordinate and execute HR training transactions in LMS, support classroom course logistics, manage vendor partnerships, administer feedback assessments, and contribute to Learning & Development operations. | 7+ years HR or related experience, BA/BS degree, strong communication and organizational skills, ability to manage multiple projects, and preferred training administration experience. | Responsibilities: • Excellent employment opportunity for a Senior Learning & Development Specialist - III in the Foster City, CA area. • Executes HR-related training-related transactions in LMS including assignment of HRtraining modules, maintenance of training completions, e-learning testing, activity reporting, etc. • Supports classroom course delivery and logistics by coordinating and executing course enrollment, course scheduling, preparing course materials, equipment,facilities, etc. • Generates standard and ad-hoc reports in PeopleSoft and/or LMS. • Coordinates vendor partnerships including invoices, payments, and contracts. • Coordinates employee and manager marketing efforts as well as internalcommunications between Learning & Development, HRBPs, and other traininggroups. • Ensures Learning & Development courses are up-to-date and accurate in the LMS. • Administers 360 and Upward feedback assessments. • Manages external eLearning vendor, Brainshark, and ensures new users receivetraining and account set-up. • Participates in the on-going evolution of the Learning & Development organization interms of values, operations, and service delivery. • Contributes to HR projects providing status updates and process flow developments,knowledge transfer and training to the Learning & Development team. Experience: • Specific education and experience requirements: 7+ years of experience in Human Resources or related area and a BA/BS. • Must be able to perform job responsibilities and duties under minimal supervision. • Strong verbal, written, interpersonal and telephone communication skills are required. • Ability to interface effectively with all levels. • Effective team-working skills. • Must have strong organization and time management skills and be able to managemultiple projects and/or tasks simultaneously. • Possess a strong customer service orientation while maintaining a high level ofintegrity and confidentially with each interaction. • Independently understand, follow and implement complex instructions. • Ability to use good judgment in making decisions. • Ability to oversee the work of vendors, contractors, and temporary employees. • Experience in training administration is preferred.

Manage and coordinate HR training activities including LMS administration, course logistics, vendor partnerships, and internal communications to support Learning & Development initiatives. | 7+ years HR or related experience with strong organizational, communication, and vendor management skills, and ability to work independently. | Responsibilities: • Excellent employment opportunity for a Senior Learning & Development Specialist - III in the Foster City, CA area. • Executes HR-related training-related transactions in LMS including assignment of HRtraining modules, maintenance of training completions, e-learning testing, activityreporting, etc. • Supports classroom course delivery and logistics by coordinating and executing course enrollment, course scheduling, preparing course materials, equipment,facilities, etc. • Generates standard and ad-hoc reports in PeopleSoft and/or LMS. • Coordinates vendor partnerships including invoices, payments, and contracts. • Coordinates employee and manager marketing efforts as well as internalcommunications between Learning & Development, HRBPs, and other traininggroups. • Ensures Learning & Development courses are up-to-date and accurate in the LMS. • Administers 360 and Upward feedback assessments. • Manages external eLearning vendor, Brainshark, and ensures new users receivetraining and account set-up. • Participates in the on-going evolution of the Learning & Development organization interms of values, operations, and service delivery. • Contributes to HR projects providing status updates and process flow developments,knowledge transfer and training to the Learning & Development team. Experience: • Specific education and experience requirements: 7+ years of experience in Human Resources or related area and a BA/BS. • Must be able to perform job responsibilities and duties under minimal supervision. • Strong verbal, written, interpersonal and telephone communication skills are required. • Ability to interface effectively with all levels. • Effective team-working skills. • Must have strong organization and time management skills and be able to managemultiple projects and/or tasks simultaneously. • Possess a strong customer service orientation while maintaining a high level ofintegrity and confidentially with each interaction. • Independently understand, follow and implement complex instructions. • Ability to use good judgment in making decisions. • Ability to oversee the work of vendors, contractors, and temporary employees. • Experience in training administration is preferred.

Author and finalize Module 3 regulatory documents and responses, support process development teams with CMC aspects, and contribute to regulatory submissions. | 7+ years relevant experience in biochemical/chemical engineering or related field with expertise in CMC regulatory submissions, biologics analytical/process development, and strong technical writing skills. | Job Description Responsibilities: • Excellent employment opportunity for a Technical Writer - III in the Santa Monica, CA area. • Contractor Role JD: CMC TW/Technical Role • Seeking a highly motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience. • This position is part of the Process Development organization and in this role, this individual will be supporting the internal Process Development teams. • In the near-term, this role will support time critical CMC Regulatory submissions. • Longer-term, this individual will be embedded in technical teams within the Process Development department supporting CMC aspects of our growing pipeline projects. • Author and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts • Experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, awareness of ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates. Experience: • Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant experience • Experience CMC/Module 3 regulatory submissions • Experience in technical writing and proficient in high quality writing • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process development • Thorough knowledge of biologics analytical and process development is essential. • Cell therapy process development experience is highly desired • Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing • Working knowledge of regulatory requirements for biologics, pharmaceuticals and medical devices • Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions • Ability to think critically, and demonstrated troubleshooting and problem solving skills • Self-motivated and willing to accept temporary responsibilities outside of initial job description • Well-developed computer skills and fluent with Microsoft office applications • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities