8 дней назад
Manager, Manufacturing Science & Technology
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Manufacturing Science & Technology (Biotechnology and GMP Manufacturing): Leading technology transfer, process monitoring, validation, and commercial-scale GMP manufacturing support for drug substance and drug product operations with an accent on process compliance, quality standards, and cross-functional execution. Focus on coordinating process start-up activities, closing deviations, managing change controls, and supporting process characterization and PPQ activities.
Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings, events, and visits to CDMO sites is expected, with travel of up to 40%. Candidates located on the East Coast, particularly in Ohio, Massachusetts, and Rhode Island, are strongly encouraged to apply.
Company
is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.
What you will do
- Lead and execute end-to-end technology transfer activities from process development through commercial-scale GMP manufacturing.
- Conduct facility fit assessments and coordinate process start-up activities.
- Review batch records, SOPs, raw material specifications, development reports, and GMP protocols.
- Provide real-time, in-plant support during production campaigns while monitoring process parameters and quality standards.
- Trend process data, support process improvements, and drive closure of process deviations in Veeva.
- Support change controls, process comparability assessments, process characterization, PPQ activities, SOW reviews, and supply chain risk mitigation.
Requirements
- Bachelor’s degree in Biotechnology, Chemical Engineering, Pharmaceutical Engineering, or a related field.
- At least 5 years of relevant experience.
- Technical background in drug substance operations, including upstream cell culture and/or downstream purification, and/or drug product operations.
- Hands-on experience with GMP manufacturing, process validation, and technology transfer teams.
- Strong verbal and written communication, interpersonal, and cross-functional collaboration skills.
- Ability to work independently in a fast-paced, multidisciplinary environment while working remotely.
Nice to have
- Expertise in drug product fill processes.
Culture & Benefits
- Fully remote work with purposeful opportunities for in-person collaboration.
- Medical, dental, vision, and mental health support, plus an annual wellbeing reimbursement.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) plan with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning programs, LinkedIn Learning access, mentorship, employee resource groups, and service opportunities.
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