mRNA Analytical Development - CRO Project Manager
needed for a contract opportunity with Yoh Scientific's client located in Waltham, MA.
This position is in the mRNA
Analytical Development Team
of a major pharmaceutical company, and requires a Bachelor's of Science degree
and 5+ years of experience in the biotechnology/pharmaceutical industry. Schedule is full-time M-F (7am-8am start time, 8 hour shift)
and may require flexibility to work some evenings and overtime due to projects.
- Experience in QC operation including deviation, OOS/OOT investigation, validation, tech transfer, CAPA, CCR etc and CRO/CTL management experience.
- Manage analytical testing outsourced to multiple CROs /CMOs. Collaborate with internal and external teams to set priorities, plan activities, monitor progress, make decisions, resolve issues, and identify risks and mitigation plans.
- Track timelines, milestones, and deliverables for outsourced projects to provide input into overarching program plan.
- Manage sample shipment tracking, inventory for drug substance and drug product production. Coordinate with multiple vendors for testing and results output.
- Follow up with internal and external tasks for documents writing, review, and approval including protocols, reports, procedures, and specifications.
- Assist in the development of new contracts with external CROs / CMOs. Track invoices against purchase orders. Assist with budget planning and development.
- Bachelor's or Master's degree in life sciences or engineering.
- 5-8 years (Bachelor's) / 3-5 years (Master's) experience in a similar position, 5-10 total years' experience in the biotechnology / pharmaceutical industry.
- Demonstrated success in managing multiple projects effectively.
- Ability to effectively represent the Company to external CROs and CMOs.
- Experience with analytical method development and qualification, process development, and cGMP manufacturing and release.
- Desire to work in a fast-paced environment.
- Excellent organizational and communication skills.
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
to contact us if you are an individual with a disability and require accommodation in the application process.