What are the responsibilities and job description for the Principle Scientist, Method Development Protein Specialist position at Aliri?
About Us:
Aliri is committed to solving industry challenges by bringing innovative bioanalysis and spatial solutions to biotech and pharma, as the complexity of the drug development landscape continues to rise.
Primary Purpose:
Plans and directs method development projects and studies in compliance with appropriate SOPS and regulatory guidelines. Develops, modifies, validates, and performs methodology for routine and/or non-routine analyses.
Job Duties and Responsibilities:
• Organizes, conducts and evaluates analytical results and testing with consideration to applicable methods, protocols, SOPs, and regulatory agency guidelines.
• Maintains study documentation and laboratory records.
• Independently sets-up, maintains, operates and performs routine and non-routine maintenance on general equipment, including problem identification and resolution as directed.
• Provides timely updates for individual analytical runs or project status to PAI and or Management.
o Performs initial reviews of analytical data for acceptability of calibration, control values, chromatography, and quantitative limits.
o Ensures all data meets acceptance criteria and troubleshoots failures.
• Ensures all data is analyzed, processed, and compiled in a timely manner
• Performs QC review of data.
• Identifies and proactively addresses deviations from normal results and informs Principal Analytical Investigator and/or management of any problems and/or deviations that may affect the integrity of the data; recommends corrective action of problems.
• Promotes a cohesive team environment.
• Sets up and performs method development and validation of various analytes in a variety of matrices with little or no supervision.
o Independently searches for and reviews scientific literature for content related to new method development/validation projects
• Suggests and performs modifications in test methods or procedures where precedence exists.
• Provides input and participates in project meetings, plans, monitors and guides project work.
• Serves as lead chemist on projects, may oversee a small group of technical staff for assigned projects, with minimal supervision.
o May perform in role as Principal Analytical Investigator (PAI) as directed.
• Ability to implement an action plan for solving project or technical problems as they occur.
• Leads in the troubleshooting of equipment and methods.
• Learns to act as an expert in key scientific area (i.e., mass spectrometry, chromatography, robotics)
o Evaluates and applies new technologies and instrumentation.
• Maintains a clean and safe laboratory work environment.
• Trains staff in advanced analytical techniques
o Trains staff in the operation, maintenance, and troubleshooting of laboratory equipment.
o Leads training sessions related to job functions; may provide in-house training and seminars to develop staff.
• Interacts with internal and external clients
o Participates in client visits as needed
o Communicates technical information to external clients.
o May attend and represent the company at conferences and other events.
• Actively participates in process improvements to increase equipment utilization and sample processing efficiencies.
• Functions as technical resource for the department.
• Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
o Schedules individual projects to ensure completion within required timelines.
o Able to review work of others for overall accuracy, timeliness, completeness, and soundness of technical judgment.
• Writes, revises and reviews methods, SOPs and portions of reports and protocols.
o Assists in evaluation of data for incorporation into written reports.
• Performs other related duties as assigned.
Experience:
Bachelor's Degree in Chemistry or related Scientific field with 10 years experience is required -OR-
Master's Degree or equivalent in Chemistry or related Scientific field with 9 years experience is required -OR-
Ph.D. or equivalent in Chemistry or related Scientific field with 7 years experience is required
*Significant work experience will be considered as a substitution for education
Knowledge, Skills, and Abilities:
Understands the method development and method validation process.
Performs complex analytical methods on biological matrices, often involving problem solving situations.
Applies and interprets scientific theories, concepts, techniques, and regulatory requirements in bioanalytical and mass spectrometry studies and accepts leadership role in developing scientific approaches.
Works in a team work setting, for technical direction on complex bioanalytical and mass spectrometry projects.
Tracks hours on a consistent project to project basis.
Monitors, evaluates, and reviews the scientific performance of assays.
Produces novel work that could be considered for scientific papers which are published in peer reviewed journals.
Able to participate in sponsor visits/audits and can reliably answer audit questions with technical clarity.
Understands how the importance of a production friendly method and the measures/steps required to make this achievable with their projects.
Drives issues observed when in validation to conclusion.
Tracks hours on a consistent project to project basis and is able to provide good rational for extending contract hours when necessary for a project.
Can contribute to long range planning for technical policies and regulatory considerations.
Can adjust scheduled work on a priority basis while still maintaining suitable advancement of other ongoing projects or diligently message when this is not possible.
Able to mentor junior chemists in other groups and help build solid good practices within the lab.
Proficient in experimental design to efficiently overcome problems encountered in MD/troubleshooting with minimal amount of runs (i.e. covers several variables with good experimental design in order to allow multiple conclusions).
Recognized expert in specific areas of assays in either drug class, extraction type, or instrumentation.
Method development on new or unusual technologies including extraction types, instrumentation, and entities (Biomarkers, low level detection, highly polar molecules).
Can designate a development track with given information such as drug class, necessary sensitivity, endogenous interference, and limited sample volume.
Preferred Qualifications:
Former Bioanalytical CRO experience; Customer service experience; LIMs experience: Strong written and verbal communication skills.
Working Conditions:
May work with potentially hazardous substances.
Mandatory immunizations and screening as required.
Overtime and weekend work as required.
Work requires some standing and sitting for long periods of time, including working within a laboratory hood and at standing bench top.
Work requires use of PPE (personal protective equipment).
Benefits:
- Medical and Dental Insurance through United Health Care
- $6,350 Qualified High Deductible Health Plan with an employer HSA contribution
- $3,300 Qualified High Deductible Health Plan with an employer HSA contribution
- $1,500 PPO Copay Plan, with choice of FSA
- Dental PPO Plan
- Vision insurance through VSP
- Additional life insurance options
- Employer Paid Basic Life & Accidental Death & Dismemberment (AD&D)
- Accident and Critical Illness and hospital indemnity plan
- Health savings and Flexible spending accounts
- Bonus Plans and rewards and recognition programs
- 401K with matching
- Fitness and Warehouse Club reimbursements
Aliri Bioanalysis provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
