- Страна
- США
- Зарплата
- 115 000 $ – 145 000 $
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Manager, Site Facility Operations
Стабильная компания в растущем секторе биоаналогов с прозрачным диапазоном зарплаты. Четко прописанные обязанности и требования делают позицию привлекательной для опытных операционных менеджеров.
Сложность вакансии
Роль требует глубоких знаний стандартов GMP/GLP и опыта управления опасными отходами. Высокая ответственность за координацию множества отделов и соблюдение строгих регуляторных норм в биофармацевтике.
Анализ зарплаты
Предлагаемый диапазон $115k–$145k полностью соответствует рыночным ожиданиям для позиции менеджера по эксплуатации в фармацевтическом секторе Калифорнии. Верхняя граница диапазона конкурентоспособна для кандидатов с магистерской степенью и значительным опытом.
Сопроводительное письмо
I am writing to express my strong interest in the Manager, Site Facility Operations position at Coherus Biosciences. With extensive experience in managing GMP-compliant laboratory environments and a proven track record in facility maintenance and vendor management, I am confident in my ability to support your Quality Control Labs and research organization. My background includes overseeing complex equipment procurement, qualification processes, and ensuring strict adherence to EHS and hazardous waste regulations.
Throughout my career, I have excelled at bridging the gap between scientific needs and operational efficiency. I have successfully negotiated high-value service contracts and implemented streamlined inventory management systems that reduced downtime. I am particularly drawn to Coherus because of your expansive biosimilar pipeline and commitment to operational excellence. I look forward to the possibility of bringing my expertise in pharmaceutical facility leadership to your team in Camarillo.
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Описание вакансии
Title: Manager, Site Facility Operations
Reports to: Vice President, Quality Laboratory
Location: Camarillo, CA
Classification: Exempt
Overview:
The successful candidate will oversee facilities and operations management to enable our Quality Control Labs and research organization in advancing our exciting and expansive biosimilar pipeline. We are seeking a candidate with experience managing a GMP lab, including equipment, facilities and the various state licenses related to hazardous waste generation, removal, etc.
Responsibilities:
- Working closely with scientific staff to evaluate the maintain laboratory equipment operations, coordinate facility activities, waste pickups, hosting regular operations updates and supporting new employee on-boarding.
- Managing on-site and offsite
- Developing sourcing strategies with numerous vendors including daily lab consumables, production to service consumables, & general materials for non-clinical operations.
- Ability to negotiate software and equipment service contracts with regard to quality and cost
- Managing facilities group inclusive of building maintenance and upkeep.
- Managing shipping/receiving, sample intake and
- Managing equipment procurement, qualification, periodic maintenance and
- Coordinating pickup of hazardous waste from the site
- Coordinating and working with supply centers & lead department purchasing
- Performing regular inventory counts with the ability to progress technology within this
- Collaborating with key partners such as Environmental Health Services, Quality Labs, Purchasing,
- Familiar with IT data software solutions for lab operations as well as ERP
- Providing operational support to senior leadership staff and work directly on continuous improvement and operational excellence.
- Authoring and review of SOPs, memos, reports, deviations and change controls.
Qualifications:
- Masters with 2+ years experience OR
- BA/BS with 5-7+ years of experience in the Life Sciences Field OR
- Associates Degree / High School with 10+ years/9+ years of experience in the Life Sciences Field
- Experience leading Pharmaceutical facilities and laboratory operations
- Experience managing purchasing and general supply of laboratory supplies and reagents, working with cross-functional groups to track orders, reconcile orders, invoices, and receipt confirmations
- Experience overseeing MSA/MTA/SOW processes for laboratory services and laboratory materials
- Experience leading and tracking capital equipment purchases and installations for the Quality Labs and Research Department in collaboration with the leadership team, finance, and facilities
- Experience collaborating cross-functionally with other departments such as: Legal, Facilities, Finance, and IT teams
- Experience overseeing and maintaining facility policies and procedures for equipment maintenance, laboratory cleanliness and organization, and Environmental Health and Safety requirements
- Experience leading Environmental Health and Safety initiatives seeking to continually improve safety culture and processes with the EHS department
- Excellent organizational, interpersonal, verbal, and written communication skills are
- Experience with GMP and GLP requirements
The Base Salary Range for this position is $115,000 to $145,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.
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Навыки
- ERP
- Vendor Management
- GMP
- Procurement
- EHS
- GLP
- S&OP
- Facility Management
- Hazardous Waste Management
- Laboratory Operations
Возможные вопросы на собеседовании
Проверка понимания специфики работы в регулируемой среде.
Опишите ваш опыт управления лабораторией в условиях строгого соответствия стандартам GMP и GLP.
Оценка навыков управления закупками и бюджетом.
Как вы подходите к ведению переговоров по контрактам на обслуживание оборудования и ПО для оптимизации затрат без потери качества?
Проверка знаний в области безопасности и экологии.
Расскажите о вашем опыте взаимодействия с надзорными органами по вопросам утилизации опасных отходов и соблюдения норм EHS.
Оценка лидерских качеств и умения работать в команде.
Приведите пример, когда вам приходилось координировать работу нескольких отделов (IT, финансы, юристы) для реализации крупного проекта.
Проверка навыков решения проблем.
Как вы приоритизируете задачи при одновременном возникновении сбоя в работе критического лабораторного оборудования и проблем с эксплуатацией здания?
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- Страна
- США
- Зарплата
- 115 000 $ – 145 000 $