Associate Director, Patient Sample Operations Advisor (PSOA)
New Jersey, US; Cambridge, US; Gaithersburg, US | full time | Job ID: 8774
The Associate Director, Patient Sample Operations Advisor will support initiatives for Clinical Trial and Commercial Patient Samples. This role will serve as a regional trusted partner for both internal and external stakeholders in the area of collection for individualized therapies that Biontech offers.
Responsibilities:
- Adherence to the regulatory requirements and the respective procedures (policies, SOPs, instructions).
- Building, tracking, and reporting on the project planning associated with patient sample collection (tumor samples, blood and apheresis) qualification process and the site onboarding process.
- Experience interfacing with cross functional departments associated with conducting apheresis center and clinical site qualification.
- Provide real time support to operations specialists, apheresis centers, pathologists, labs and site sample collection centers for both clinical trial and commercial orders.
- Escalation and communication of ongoing topics associated with the support of apheresis operations and sample management within the region.
- Oversee site performance/experience and partner with internal and external stakeholders to implement enhancements as needed.
- Operational support as process expert for patient sample and apheresis operations activities.
- Ability to train centers on BioNTech collection processes.
- Subject matter experts that input into document creation in support of required activities for both internal and external teams.
- Document management of required documents from external centers.
- Involvement in recruiting, coaching and training of team members to acquire all theoretical and practical knowledge to guarantee functional management of the Clinical Trial Supply Management Patient Operations activities.
- Ad-hoc projects
- Travel: ability to travel up to 70% of the time to support site on-boarding and training.
Requirements:
- Degree in pathology, lab, pharmacy, chemistry, biotechnology, biochemistry, nursing, or related discipline or engineer with profound understanding of natural scientific processes
- Relevant professional experience (usually +5 years) in Pharmaceutical or Biotech or any other equivalent industry setting, working in or with pathology labs, apheresis centers to ensure appropriate collection of patient material for the purposes of manufacturing treatment product
- Project Management Experience
- Problem solving skills
- Excellent communication and presentation skills
- High level of learning agility to handle ambiguous events
- Demonstrated quality management experience
- Adherence to project timelines
- Business-professional English language skills
- Profound skills in the application of standard software (e.g. MS Office)
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Your Benefits:
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance
…and more! More details to be shared.
Expected Pay Range: $160,000/year to $200,000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
Berkeley Heights is New Jersey's growing hub within the life sciences industry and has already demonstrated the state’s commitment to innovation, collaboration, and excellence within the field. New Jersey's integrated approach to biotechnology and pharmaceuticals harmonizes academic rigor, industrial capability, and government support to create thriving conditions for a growing ecosystem. Cultivating an environment that seamlessly integrates cutting-edge research, robust manufacturing capabilities, and a dynamic business landscape, New Jersey has become a powerhouse in pharmaceuticals, biotechnology, and medical technology. As this region of New Jersey continues to develop, it stands ready to shape the future of medical science and technology, driving progress and improving health outcomes worldwide.
Apply now - We look forward to your application!
Apply for our New Jersey, US; Cambridge, US; Gaithersburg, US location and simply send us your documents using our online form.
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.