Manager, In Vivo Services

Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. We are currently seeking energetic scientists and professionals to support our clients in the pharmaceutical, biotech, and medical device fields. Join us in our mission to improve public health through science!  

PBL has an immediate opening for a full-time onsite In Vivo Services Department Manager. The In Vivo Services Manager will be responsible for the daily operation and management of the department ensuring that the needs of clients are met in accordance with applicable testing standards and industry regulations. The position reports to the General Manager.

PRIMARY RESPONSIBILITIES FOR THE IN VIVO SERVICES MANAGER INCLUDE BUT ARE NOT LIMITED TO

• Manage the In-Vivo Service Department personnel in ensuring early/on-time delivery of results/reports 
• Ensure that the Department consistently operates in compliance with cGMP/GLP/ISO/ASCA/IACUC requirements
• Assume GLP Study Director or Analyst responsibilities as needed and work together with other testing departments to create a cohesive working environment for all employees
• Play a lead role focused on internal efficiency and quality of work performed in the In Vivo Services Department
• Independently oversee the day-to-day operations of In Vivo personnel in the execution of contracted in-life toxicology, pharmacology, and pharmacokinetic studies with new and existing clients
• Oversee Animal Care personnel in all aspects of daily operations of the vivarium in collaboration with the Attending Veterinarian 
• Oversee activities of team leaders and GLP Study Directors in the testing areas of cytotoxicity, biocompatibility, dosing, potency, ISO 10993 sample preparation and systemics 
• Play a lead role in maintaining a rigorous training program for new and current personnel
• Participate and lead external audits (e.g., Client/Sponsor/Regulatory) and always be audit ready
• Develop and/or support efforts focused on introducing new techniques/procedures in support of expansion efforts
• Function as the department representative in interactions with internal clients, regulatory agencies, collaborators, veterinarians, and external clients
• Contribute to Business Development through active participation with Project Managers and inter-departmental Managers/Directors in client conference calls, study quoting/costing and visiting local Bay Area clients, as applicable
• Streamline routine operations and resource planning based on business needs
• Interview and hire potential candidates to fulfill business needs
• Motivate the team and participate in team building activities 
• Perform other tasks and assignments as needed and specified by Management

QUALIFICATIONS AND SKILLS FOR THE IN VIVO SERVICES MANAGER 

• Ph.D. in Toxicology, Pharmacology, or other relevant scientific discipline.
• A minimum of 8 years of GLP/cGMP experience in a CRO or related industry.
• Candidates with a Master's Degree with extensive laboratory management experience (8+ years) are also encouraged to apply
• Relevant laboratory management experience (10+ years) may substitute for an advanced degree, but GLP/cGMP knowledge is a must. 
• A strong publication record in peer-reviewed scientific journals is preferred but not required.  
• A minimum of 5 years experience as a people manager. Candidates with a proven record of management of scientific laboratory personnel will be given priority.
• Broad knowledge of toxicology and pharmacology testing required.
• Knowledge of ISO/IEC 17025 and the FDA ASCA pilot program requirements is highly desired

 TECHNICAL SKILLS

• Independent project management, leader, and mentor
• Able to effectively communicate and train staff
• Proficient in study designs including small molecule ADMET as well as RNA/oligonucleotide and gene/cell therapy studies 
• Excellent documentation and technical scientific writing skills
• Effectively operate in an evolving, complex, and dynamic environment
• Advanced math skills, biostatistics preferred
• Critical thinking skills for advanced problem solving/risk assessing in the sciences
• Proficient in aseptic technique
• Able to analyze data and draw conclusions based on relevant guidelines and industry standards
• Experience in managing a small to midsize vivarium 
• Knowledge of medical device testing including ISO10993 is highly preferred 

PHYSICAL ABILITIES

• Ability to lift 30 pounds and stand for extensive periods of time
• Utilize ergonomics to perform repetitive motion tasks with hands and arms 

SAFETY/HAZARD INFORMATION

• Ensure labs are clean and safe and properly stocked
• Ensure personal protective equipment (PPE) is used worn in the lab at all times by peers and self
• Ensure proper handling and disposal of chemical, biological, animal, and sample waste
• Demonstrate safe handling and behaviors and perform safety lab checks
• Ability to tolerate the smell of laboratory disinfectants
• Able to work safely with Biosafety Level II (BSL II) microorganisms and bloodborne pathogens

ADDITIONAL INFORMATION

• Able to effectively navigate computer systems and multiple complex software platforms 
• Ability to work off shift hours and weekends when needed
• Knowledge of California and Federal Human Resource laws
• Local candidates preferred
• Must be onsite during department business hours Monday – Friday and as needed on weekends. 

The base pay offered for this position is $130,000 to $180,000 and will take into account internal equity and may also vary depending on the candidate’s job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits. 

Pacific BioLabs is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected factors.