Category: Research & Development | Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 3934
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The BioAnalytical Manager (BAM) works within the Early Development (ED) Department and works closely with pharmacologists, toxicologists and PK scientists and bioanalytical contract labs to establish analytical methods, manage method validations, stability studies and sample analysis.
This individual will be responsible for leading bioanalytical activities at bioanalytical CROs and review documents for scientific rigor and data accuracy for method validations, clinical and nonclinical bioanalytical data. This individual will be able to work independently and within ED and provide timely support to PK scientists, toxicologists and pharmacologists.
The BAM simultaneously assigned to multiple studies and is an agenda-driven ad-hoc member of the study teams. The responsibilities of BAM include: managing reagent supply, method validations, sample analysis, ensuring receipt of SOW deliverables, resolving issues.
- Support development and validation of bioanalytical LC/MS methods for discovery, non-GLP pharmacokinetic/pharmacodynamic studies and GLP toxicology studies.
- Collaborate with CROs for monitoring sample analysis to support GLP toxicology and nonclinical studies.
- Review and finalize protocols, method validations, stability studies and bioanalytical reports that meet all applicable regulatory requirements.
- Effectively collaborate with bioanalytical CROs and ensure all studies are completed in a timely manner.
- Interact closely with ED team members to ensure that bioanalytical activities are prioritized appropriately and the deliverables are achieved in a timely manner.
- Ability to manage multiple projects in the pharmaceutical industry.
Required Knowledge, Skills, and Abilities
- Experience working in bioanalytical laboratory in method development, validations or sample analysis is required. Thorough scientific knowledge in small and large molecules (nucleotides, enzymes or monoclonal antibodies) is preferred.
- Thorough understanding of method validations, sample analysis, GLP, GCP requirements, ICH guidelines and FDA guidance.
- Experience in working with clinical and preclinical teams.
- Must be detail oriented with strong documentation and organizational skills.
- Proven ability to oversee validation work and sample analysis at CRO’s.
- Excellent written and oral communication skills.
- Excellent contingency planning and time management skills and demonstrated ability to manage a number of projects simultaneously.
- Strong problem solving and analytical skills, and be capable of independent and creative thinking.
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment.
- MSs degree in chemistry, analytical sciences or relevant discipline and 5-10 years of experience in bioanalytical function required. PhD is a plus.
Description of Physical Demands:
- Routine mobility within office environment.
- Routine sitting for extended periods of time.
- Significant travel to oversee outsourced activities.
- Operating a computer, printer, telephone and other similar office machinery.
- Description of Work Environment:
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.