от компании (организации): АО ВЕРОФАРМ в городе (населённом пункте): Москва, Россия
в отрасли экономики "Производство, сельское хозяйство" → "Фармацевтическая промышленность"
с заработной платой: по договоренности
Вакансия № 16748420 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Четверг, 10 октября 2024 года.
Дата обновления вакансии № 16748420 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 10 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 16748420 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
3–6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Process Development Engineer (technology transfer)
«ВЕРОФАРМ» (группа Abbott) – российский производитель лекарственных препаратов и изделий медицинского назначения, портфель компании насчитывает более 300 наименований продукции.
«ВЕРОФАРМ» является крупнейшим в России производителем онкологических лекарственных средств, а также известен в таких направлениях медицины как женское здоровье, гастроэнтерология, инфекционные заболевания, дерматология и других мировых отраслях здравоохранения.
Развивая достижения и активы «ВЕРОФАРМ», Abbott инвестирует в модернизацию производственной инфраструктуры компании, в расширение научно-исследовательских возможностей, маркетинговые и образовательные программы на благо россиян и российской системы здравоохранения.
Мы приглашаем Вас присоединиться к нашей команде в роли Инженера по развитию процессов (технологический трансфер).
!! Готовность к командировочной активности от 40% рабочего времени и больше (г. Белгород и п. Вольгинский).
Primary Job Function:
Key role in the success of the transfers of MAKE products to manufacturing facilities (internal and external)
Process development, optimization and scale up for MAKE products
Practical execution and evaluation of validation activities as well as execution of manufacturing process documentation during transfers
Development and implementation of process training for production employees
Close collaboration with I&D CoE and receiving Manufacturing sites to support builds for new products in prototype, pilot and production setting, including training of Operators, Technicians, and Manufacturing Engineers
Core Job Responsibilities:
- Formulates hypothesis, designs experiments (DOE), collects and analyzes data and presents solutions to R&D and manufacturing teams.
- Partner with product development to ensure new formulation meets pre-established technology transfer readiness criteria (“bull’s eye”)
- Lead scale up activity through pilot and manufacturing in conjunction with Product Development and Manufacturing Engineering teams. Provide Subject Matter Expert process support to operations during transfer campaigns.
- Work with cross-functional teams to understand product/process risk and characterize processes to mitigate risk.
- Author and review technical documents to support Technology Transfer activities.
- Provide guidance on design of experiments, data analyses and derivation of appropriate conclusions to junior staff. Mentor junior staff in scale up and validation activities
- Drive ongoing innovation and technology scouting activities, including networking opportunities which contribute to our development and help promote innovative technology and therapeutic ideas leading into novel drugs in the field.
- Ensure that any issues related to product or process technology are identified, a root cause analysis conducted, and corrective actions implemented to ensure resolution. Lead transfer related investigations.
- Develop and author Technology Transfer Protocols and Reports, review data summaries, technical reports, tech transfer packages, regulatory submissions and presentations
- Lead/participate in evaluation of new technology and process automation for introduction into GMP manufacturing
- Ensure high quality science, innovation, technology and deliverables, ensuring compliance with respective regulatory and quality requirements
- Works closely with Technology Transfer Lead to establish and maintain a culture of learning and continuous improvement through capturing lessons learned and enabling cross-project collaboration
- Responsible for the compilation of required GMP related and regulatory documents
Supervisory/Management Responsibilities:
Direct Reports: N/A
Indirect reports: Approximately 4-6 in matrix structure from EPO, as well as supportive departments; e.g. Product Development, Regulatory, QA Development, Clinical Development, Site PM or equivalent resources in external co-operations.
Position Accountability/Scope:
- Design and flawless execution of technology transfers from development to manufacturing
- This position has a significant impact on the end results for successful completion of an assigned technology transfer
- Acts as primary contact for all scale up/validation assigned technology transfers and is accountable for delivering on all assigned technology transfers to manufacturing sites (internal and external)
- Technical oversight of site manufacturing personnel SMEs during Technology Transfer execution. Ability to guide manufacturing personnel in equipment qualification and cleaning validation
- Key contributor for successful filings of high-quality CMC dossiers and approval of products.
Minimum Education:
Advanced academic degree in a scientific or technical field, preferably in Engineering (pharmacy, chemistry, analytical chemistry, industrial engineering and management).
Minimum Experience/Training Required:
- BS/MS in Chemical Engineering, Biochemical Engineering, Material science or related discipline with at least 10 years of relevant product and process development experience, as well as in authoring technical documentation to support regulatory submissions
- Strong technical expertise in Process Design, Optimization & Scale-up, Technology Transfer, Process Analytical Technology and manufacturing support to large scale operation
- Ability to influence, lead and drive change
- Strong understanding of regulatory requirements in the industry and cGMP manufacturing considerations
- Able to challenge current practices to constantly improve competitiveness, develop ideas and realize innovation.
- Excellent communication skills in English, both verbal and written
*Заявленное описание вакансии, а также список требований к вакансии не является полным.
Ещё больше информации про наши условия можно узнать на встрече с представителями команды по подбору.
Откликнуться на эту вакансию: Process Development Engineer (technology transfer)
Предыдущая вакансия:
Вакансия № 16748414 на должность Оператор производственной линии (г. Краснознаменск) от компании ООО Торговый дом Премиум Табакко в городе (населенном пункте) Краснознаменск