Scientist/Senior Scientist: Bioanalytical
Amunix Operating Inc. is seeking an experienced, resourceful, hands-on individual to join our expanding Preclinical team in the role of Scientist/Senior Scientist, Bioanalytical. The Scientist will oversee regulated bioanalytical PK and ADA development in support of nonclinical and clinical studies.
The successful candidate will possess deep scientific knowledge and technical experience in developing, troubleshooting, transferring, optimizing and validating PK and ADA assays for biotherapeutics in biological matrices. He/she must be able to design and oversee the execution of bioanalytical method development and validation studies using accepted industry methods with minimal guidance and supervision. The qualified candidate will be knowledgeable of current FDA and EMA GLP/GCP compliance as it relates to bioanalytical PK and ADA methods. The candidate is expected to manage bioanalytical projects, communicate and manage CROs to ensure high quality Bioanalytical data/reports to be delivered in accordance with project timelines. This position will report to the VP, Preclinical Development and interact with other members of the organization including the Clinical Department and Quality Assurance.
Essential duties and responsibilities include the following:
- Design, implement and manage PK and ADA assay development in accordance with current industry standard for drug candidates in support of nonclinical and clinical stage oncology programs.
- Experience in identifying and selecting high quality CROs for the conduct of nonclinical and clinical bioanalytical work.
- Able to successfully transfer and validate bioanalytical methods at CRO, and oversee the subsequent analysis of nonclinical and clinical samples.
- Review and interpret bioanalytical data/reports from nonclinical studies and clinical trials.
- Effectively communicate with other departments within the organization as well as CROs.
- Provide project summaries/reports in project team meetings.
- Experience in preparation of summary sections for regulatory (IND or foreign equivalent) filings is a plus.
- Ph.D. in relevant scientific discipline and at least 5+ years of bioanalytical laboratory experience a must.
- Pharmaceutical, biotechnology or CRO experience is highly desirable.
- Knowledge of different PK and ADA formats and industry assay validation requirements.
- Proven ability to think critically and creatively to identify and solve bioanalytical assay development challenges.
- Excellent written and verbal communication skills, and ability to write technical reports.
- Excellent organizational skills, attention to detail and the ability to work independently and within a multi-disciplinary environment as well as with external vendors
- Must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
- Physical ability to lift up to 40 lbs and work at the lab bench for extended periods of time.
- Must be prepared to travel.
We are a biopharmaceutical company developing first-in-class products using our novel half-life extension/drug delivery platform technology. As an employee, you will be able to:
- Significantly contribute to an established company (est’d 2006) with a broadly partnered and validated technology platform which is engaged in the development of a number of novel internal pipeline molecules
- Work in a highly collaborative and motivated working environment
- Receive a comprehensive benefits package, including Health, Dental, Vision, Life Insurance, Short-term/Long Term Disability and participate in matching 401(k) plans
- Receive compensation based on candidate experience
Amunix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Amunix complies with applicable state and local laws governing nondiscrimination in employment in every, location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation and training.